The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC).
All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

Start Date01 Nov 2025

Sponsor / Collaborator

The University of Chicago

NCT06780787

/ Not yet recruitingPhase 2IIT

Phase II Clinical Trial of FOLFOX, Botensilimab, Plus Balstilimab in Patients With Localized Rectal Cancer

This phase II trial tests how well fluorouracil, oxaliplatin and leucovorin calcium (folinic acid) (FOLFOX) with botensilimab and balstilimab given before surgery (neoadjuvant) works in treating patients with rectal adenocarcinoma that has not spread to other parts of the body (localized). Currently, neoadjuvant therapy for rectal cancer includes chemotherapy and chemoradiation. Despite these aggressive treatments, only about half of patients achieve a complete clinical response. In fact, over half of rectal cancer patients go on to have surgery and often suffer post-surgery complications involving urine and bowel problems. Thus, there has been an increased focus on non-surgical treatments. Chemotherapy drugs, such as fluorouracil, oxaliplatin and leucovorin calcium, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as botensilimab and balstilimab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant FOLFOX with botensilimab and balstilimab may improve the rate of complete response and decrease the need for surgery and radiation therapy in patients with localized rectal adenocarcinoma.

Start Date30 Jun 2025

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT06622057

/ Not yet recruitingPhase 3

Phase III, Randomized, Double-blind Study of Combination Therapy With D07001-Softgel Capsules and Capecitabine vs Placebo and Capecitabine in Patients With Advanced BTC After Failed on Gemcitabine, Platin, and FOLFOX or Irinotecan Regimens

The object of this trial is to evaluate the efficacy of D07001-softgel capsules + capecitabine compared with placebo + capecitabine by overall survival (OS).
Eligible patients with advanced biliary tract cancer (BTC) will be randomized (1:1:1) to receive either 60 mg D07001-softgel, 100 mg D07001-softgel, or placebo, combine with capecitabine. Treatment will be continued until disease progression, death, withdraw consent, or completing 12 treatment cycles , whichever occurs first.

Start Date01 Apr 2025

Sponsor / Collaborator

InnoPharmax, Inc.

100 Clinical Results associated with Capecitabine

100 Translational Medicine associated with Capecitabine

100 Patents (Medical) associated with Capecitabine

11,868

Literatures (Medical) associated with Capecitabine

01 Dec 2025·Journal of Gastrointestinal Cancer

Impact of Retroperitoneal Lymphadenopathy (RPLN) on the Outcomes of Locally Advanced Gall Bladder Cancer (GBC) Following Chemotherapy (CT) or Chemotherapy Followed by Consolidation Chemoradiotherapy (CTRT)

Article

Author: Naik, Nagendra ; Priyanka, Parul ; Agrawal, Sushma

INTRODUCTION:

Retroperitoneal lymphadenopathy is considered a metastatic disease in GBC; however, some surgical series of radical surgery with enlarged RPLN who underwent RPLN dissection have shown results marginally inferior to those without enlarged RPLN. Radiological RPLN comprises a major proportion of advanced non-metastatic GBC. There is dilemma in the intent of treatment to be offered in such cases. We are reporting our series of outcome of GBC with RPLN treated with first-line CT followed by consolidation CTRT.

MATERIALS AND METHODS:

Non-metastatic locally advanced GBC with good performance status (KPS ≥ 80) were initiated on first-line CT (cisplatin-gemcitabine), and thereafter, responders were evaluated by CECT-angiography and PET-CT scan for resectability. If found unresectable, they were offered consolidation CTRT to a dose of 45 Gy by conventional fractionation (3D-CRT technique) along with concurrent capecitabine at 1250 mg/m² to GBC and regional lymphatics including RPLN. Thereafter, boost dose of 9 Gy/5# was given to GBC only. Response assessment was done using CECT abdomen by RECIST criteria v 1.1. Outcomes (overall survival) of the two groups (RPLN vs non-RPLN) were computed with Kaplan-Meier survival curves and chi-square tests using SPSS v 20.

RESULTS:

Among 189 patients of advanced non-metastatic GBC recruited from 2011 to 2022, 80 had RPLN. The demographic features of both groups were comparable. Overall, 68% of the patients were women, 30% underwent upfront stenting for obstructive jaundice, and 90% had T3 and T4 disease. Only 10% had undergone upfront laparoscopic staging and had pathologically proven RPLN. Forty percent of the patients received four cycles of CT only and 50% of the patients received six cycles or more and 33% received CTRT. By RECIST criteria, 10% vs 16% achieved complete response (CR), 39% vs 41% achieved partial response (PR), 16% vs 15% achieved stable disease (SD), 2.7% vs 6% had disease progression (PD), and 14.5% vs 3.7% were non-evaluable in non-RPLN group vs RPLN group, respectively. 12% vs 6% could undergo radical surgery in non-RPLN group vs RPLN group (p = 0.03). The median OS was 9 months (95% CI 7.6-10.3 months) vs 10 months (95% CI 8-9.8 months) (p = NS) in non-RPLN group vs RPLN group, respectively. In those who received CT only, the median OS was 7 months vs 8 months, while in those who received CT followed by CTRT, the median OS was 14 months vs 13 months (p = 0.65) in non-RPLN group vs RPLN group, respectively.

CONCLUSIONS:

Based on this analysis, we conclude that RPLN constitutes a major proportion of advanced non-metastatic GBC and has outcomes similar to those without RPLN if treated with radical intent. RPLN should not be considered a metastatic disease and should be treated with radical intent.

01 Dec 2025·CANCER CHEMOTHERAPY AND PHARMACOLOGY

DPYD genotype should be extended to rare variants: report on two cases of phenotype / genotype discrepancy

Article

Author: Goldwirt, Lauriane ; Teixeira, Luis ; Thomas, Fabienne ; Jacqz-Aigrain, Evelyne ; Vilquin, Paul ; Mourah, Samia ; Medard, Yves

The enzyme dihydropyrimidine dehydrogenase (DPD) is the primary catabolic pathway of fluoropyrimidines including 5 fluorouracil (5FU) and capecitabine. Cases of lethal toxicity have been reported in cancer patients with complete DPD deficiency receiving standard dose of 5FU or capecitabine. DPD is encoded by the pharmacogene DPYD in which more than 200 variants have been identified. Different approaches have been developed for screening DPD-deficiency, including DPYD genotyping and phenotyping. Plasma uracil ([U]) and dihydrouracil ([UH₂]) concentrations are routinely used as surrogate markers for systemic DPD activity: [U] ≥ 16 ng/ml and < 150 ng/ml, and [U] ≥ 150 ng/mL indicate partial and complete DPD deficient phenotype, respectively, while values of 5 or 10 for [UH2]/([U] ratio are often cited. Four clinically relevant DPYD defective variants (DPYD*13, DPYD*2A, p.Asp949Val and haplotype B3), are targeted in genetic testing via PCR. In practice, pretreatment [U], alone or combined with these 4 recommended DPYD alleles guides individual dosage selection, though this approach has limitations. This is illustrated by two cases showing discrepancy between DPD deficient phenotype and normal standard genotype. In these two cases, DPYD exome sequencing with Next Generation Sequencing identified rare inactive variants, establishing concordance between phenotype and genotype. In patient 1, [U] levels of 21.1 and 25.5 ng/mL, indicated partial deficiency though the targeted genotype was normal and 5FU dose was adjusted based on the phenotype. In patient 2, [U] levels of 16.2 and 15.2 ng/mL were near the 16 ng/ml threshold. With a normal genotype, he as considered non-deficient as targeted genotype was normal and the standard dose was administered. These two cases underscore the need to pair DPD phenotyping with whole DPYD gene sequencing, due to the frequent discrepancies between these pharmacogenetic tools, the burden of rare variants and ethnic differences in variant frequencies.

01 Dec 2025·Journal of Gastrointestinal Cancer

Nivolumab Combined with Chemotherapy in FGFR2 and PD-L1 Co-Expressing Metastatic Gastric Cancer: A Prospective Phase 2 NIVOFGFR2 Study

Article

Author: Guliyev, Fuad ; Otkhozoria, Nana ; Musayeva, Gunel ; Mahmudova, Samira ; Kahharov, Alisher ; Abbasov, Bahadur ; Tsimafeyeu, Ilya

BACKGROUND:

Immunotherapy is increasingly significant in treating metastatic gastric cancer. This prospective phase 2 study investigates the efficacy and safety of combining nivolumab with chemotherapy in patients with metastatic gastric cancer co-expressing FGFR2 and PD-L1.

METHODS:

Eligible patients were aged 18 years or older, with previously untreated HER-2 negative, PD-L1 positive, and FGFR2 positive metastatic gastric adenocarcinoma. Patients received nivolumab (360 mg every 3 weeks) in combination with chemotherapy (CAPOX: capecitabine 1000 mg/m² twice daily on days 1-14 and oxaliplatin 130 mg/m² on day 1, every 3 weeks). Tumor assessments were conducted using RECIST v1.1 every 8 weeks for 48 weeks, then every 12 weeks. The primary endpoint was the 1-year progression-free survival (PFS) rate. Secondary endpoints included median PFS, overall survival (OS), objective response rate (ORR), and grade ≥ 3 adverse events (AEs).

RESULTS:

From June 2022 to October 2023, 194 patients were assessed for eligibility, with 23 patients enrolled and treated. At a median follow-up of 17.3 months, the 1-year PFS rate was 30.4%, with a median PFS of 6.0 months (95% CI, 4.3-7.7). The median OS was 15.1 months (95% CI, 13.2-16.8). The ORR was 21.7%, with one complete response and four partial responses. Grade 3 or higher TRAEs were reported in 34.8% of patients, primarily associated with chemotherapy. No treatment-related deaths occurred.

CONCLUSIONS:

While the primary endpoint of improved 1-year PFS rate was not met, the study offers valuable insights into the potential benefits of combining nivolumab with chemotherapy in FGFR2 and PD-L1 co-expressing metastatic gastric cancer. Future research should optimize patient selection, assess combined immunotherapy and targeted anti-FGFR2 therapy, and further investigate the role of subsequent treatments to maximize therapeutic benefits.

330

News (Medical) associated with Capecitabine

24 Jan 2025

·www.fda.gov

Safety announcement: FDA highlights importance of DPD deficiency discussions with patients prior to capecitabine or 5FU treatment

The U.S. Food and Drug Administration (FDA) is providing this communication to increase awareness of recent updates to the product labeling of capecitabine and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All healthcare providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and discuss testing options for DPD deficiency with their patients. Fluoropyrimidines are a class of anti-cancer drugs that include fluorouracil (5-FU) and capecitabine, a prodrug of 5-FU. The DPYD gene encodes the enzyme DPD, which breaks down >80% of fluorouracil. Patients with certain homozygous or compound heterozygous variants in the DPYD gene, known to result in complete or near complete absence of DPD activity (complete DPD deficiency), are at increased risk for acute early-onset toxicity and serious, including fatal, adverse reactions (e.g., mucositis, diarrhea, neutropenia, and neurotoxicity). Patients with partial DPD activity (partial DPD deficiency) may also have increased risk of serious, including fatal, adverse reactions.Project RenewalThe FDA Oncology Center of Excellence, under Project Renewal, updated the product labeling of Xeloda (capecitabine tablets) to include additional information on DPD deficiency and the importance of discussing DPD deficiency with patients; a safety labeling change updated the 5-FU labeling to include the same DPD deficiency information as in Xeloda. The product labeling of both drugs state: Capecitabine or fluorouracil are not recommended for use in patients known to have certain homozygous or compound heterozygous DPYD variants that result in complete DPD deficiency. No dose has been proven safe for patients with complete DPD deficiency. There is insufficient data to recommend a specific dose in patients with partial DPD deficiency. All healthcare providers should inform patients of the potential for serious and life-threatening adverse reactions due to DPD deficiency. Providers should discuss with their patient whether the patient should be tested for genetic variants that are associated with an increased risk of serious adverse reactions from the use of capecitabine or 5-FU. Providers should consider testing prior to initiating capecitabine or fluorouracil to reduce the risk of serious adverse reactions. Providers should be aware of the signs and symptoms associated with adverse reactions due to DPD deficiency and advise patients to immediately contact their provider if these occur, including severe mucositis, diarrhea, neutropenia, and neurotoxicity. Providers should withhold or permanently discontinue capecitabine or 5-FU based on clinical assessment of the onset, duration, and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe reactions, which may indicate complete DPD deficiency. Four DPYD variants have been associated with impaired DPD activity in White populations, and one variant has been associated with impaired activity in individuals of African ancestry. See the full prescribing information for Xeloda and 5-FU for additional information on DPD deficiency, located in Sections 5, 12.5, and 17.The FDA will continue to monitor this safety issue and evaluate the evolving landscape and impact of DPD deficiency on the safety of capecitabine and fluorouracil; additional regulatory actions will be considered. The FDA urges patients and healthcare providers to report side effects involving capecitabine or 5-FU products to the FDA MedWatch program.

Drug Approval

24 Jan 2025

·www.prnewswire.com

CG Pharmaceuticals: Progress of U.S. Phase 1b/2 Metastatic Pancreatic Cancer Clinical Trial at the ASCO Gastrointestinal Symposium

ORINDA, Calif., Jan. 23, 2025 /PRNewswire/ -- CG Pharmaceuticals (CG Pharma), a clinical biopharmaceutical company located in the San Francisco Bay Area, was established as an independent entity in 2024 after licensing ivaltinostat from CG Invites. The company has since been conducting various research projects on ivaltinostat in the U.S. including the metastatic pancreatic cancer (mPDAC) clinical trial (NCT05249101). The results of the completed Phase 1b study and the progress report of Phase 2 will be presented at the ASCO Gastrointestinal Symposium on Friday, January 24. In the Phase 1b study, a total of 28 patients with locally advanced or metastatic PDAC who had received at least one prior line of therapy were administered ivaltinostat at 3 different dose levels (60, 125 and 250 mg/m² on days 1 and 8) in combination with capecitabine (1000 mg/m², administered twice daily on days 1-14) of a 21-day cycle. Treatment-emergent adverse event (TEAE) profile was similar across dose levels, with the most common TEAEs (primarily grade 1-2) including fatigue, nausea, palmar-plantar erythrodysesthesias, constipation, and diarrhea. No serious adverse events that were related to ivaltinostat occurred in any of the 3 dose cohorts. At the time of data cutoff (12/28/2024), there were 7 patients still alive, 18 deaths (all due to disease progression after discontinuation from study; no deaths directly related to study treatment), 1 patient lost to follow-up, and 2 study withdrawals. The longest-surviving patient has been alive for 27 months and the maximum duration of treatment was 20 months. Two thirds (65%) from a total of 28 patients showed stable disease or no evidence of disease, 14% experienced disease progression, and 22% were not evaluated. The safety and efficacy results of the Phase 1b clinical study demonstrated that ivaltinostat can be effectively combined with cytotoxic chemotherapy to treat mPDAC. With the RP2D of ivaltinostat established at 250 mg/m2 from Phase 1b, this combination is now being evaluated in the Phase 2 randomized portion of the study comparing ivaltinostat plus capecitabine versus capecitabine alone in the maintenance setting for patients with mPDAC who underwent first line fluoropyrimidine-based therapy for at least four months without disease progression in terms of Progression-Free Survival and Overall Survival. The ongoing Phase 2 trial began patient enrollment in January 2024 and has already achieved over 62% of its target enrollment across 17 U.S. clinical trial sites. CG Pharma anticipates completing Phase 2 patient enrollment and follow-ups this year, with a final clinical study report expected by mid-2026. Ivaltinostat: A Promising New Approach Ivaltinostat, an epigenetic-targeting HDAC inhibitor, has shown exceptional safety and pharmacokinetic profiles compared to other investigational agents in its class. Metastatic pancreatic cancer remains a deadly malignancy with limited treatment options, underscoring the urgent need for innovative therapies like ivaltinostat. Leadership Statements: Dr. Joong Myung Cho, founder of CrystalGenomics and majority shareholder of CG Pharma, highlighted the significance of addressing unmet medical needs through the development of new therapies like ivaltinostat: "For 40 years, I have been dedicated to developing innovative treatments for diseases with limited therapeutic options. Our Phase 2 trial for metastatic pancreatic cancer is progressing smoothly, and we look forward to sharing top-line results soon." Dr. Gene Cho, CG Pharma's Vice President of Global Strategy, remarked: "We are actively engaging with partners and investors to support CG Pharma's success. Exciting updates are forthcoming." Forward-Looking Statement Disclosure: This press release may contain certain forward-looking statements relating to the goals, business strategy, financial and market position, product development, and projections for the Company. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed, and actual results may differ. The information in this release is provided only as of the written date, and CG Pharmaceuticals undertakes no obligation to update any forward-looking statements contained in this release, except as required by law. Contact: Gene Young Cho, Ph.D. Vice President of Global Strategy at CG Pharmaceuticals, Inc. Phone: 925-259-7333 Mobile: 925-899-9637 Email: [email protected] SOURCE CG Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Phase 2Clinical Result

23 Jan 2025

·www.prnewswire.com

Cadonilimab (PD-1/CTLA-4) Phase III Data for First Line Treatment of Advanced Gastric Cancer Published in Nature Medicine

HONG KONG, Jan. 22, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is excited to announce that the prestigious medical journal Nature Medicine published the results of the company's independently developed PD-1/CTLA-4 bispecific antibody cadonilimab in combination with oxaliplatin and capecitabine for the first-line treatment of unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma in a Phase III clinical study (COMPASSION-15/AK104-302). The results of the COMPASSION-15 study were previously orally presented at the 2024 American Association for Cancer Research (AACR) Annual Meeting. This recognition represents an additional validation of cadonilimab's clinical value in addressing critical unmet need. Previously, clinical research findings on cadonilimab in the treatment of various malignancies have been published in internationally renowned journals such as The Lancet, The Lancet Oncology, Nature Medicine, Drugs, and Clinical Cancer Research. The Phase III clinical data in the Nature Medicine publication indicates that, regardless of PD-L1 expression, cadonilimab combined with chemotherapy regimen significantly improves overall survival benefits for the entire population of advanced gastric cancer patients and reduces the risk of disease-related death (OS HR 0.62). Even for the PD-L1 low-expressing and negative group, the cadonilimab regimen demonstrated a meaningful survival benefit for patients (OS HR 0.70), effectively addressing the current limitations of PD-1 monoclonal antibody first-line treatment for PD-L1 low-expression and negative gastric cancer. In September 2024, the cadonilimab regimen for the first-line treatment of advanced gastric cancer was approved and is now widely used in clinical practice, offering a comprehensive and efficacious immunotherapy option for patients. A Phase III clinical trial of cadonilimab combined with a VEGFR-2 monoclonal antibody for PD-1/L1 inhibitor-pretreated advanced gastric adenocarcinoma and gastroesophageal junction adenocarcinoma patients is currently advancing on scheduling. Akeso's comprehensive clinical strategy for both first-line and subsequent-line treatments in various cancer types will further expand cadonilimab's indications, providing a novel and effective solution for these patients. Cadonilimab's ability to target both PD-1 and CTLA-4, two key immune checkpoints, demonstrates its synergistic anti-tumor mechanisms, further demonstrating Akeso's leadership in the global bispecific antibody field for cancer immunotherapy. Currently, cadonilimab is being investigated in over 23 clinical studies across 16 indications, targeting tumor types such as gastric cancer, lung cancer, liver cancer, cervical cancer, and pancreatic cancer. In addition to the already approved indications for recurrent/metastatic cervical cancer and first-line gastric cancer, as well as the first-line cervical cancer indication currently under review, cadonilimab is also undergoing five Phase III clinical trials for liver cancer, non-small cell lung cancer, and gastric cancer. Research across multiple indications, including cervical cancer, gastric cancer, and non-small cell lung cancer, has demonstrated that cadonilimab exhibits breakthrough efficacy across "broad population", demonstrating clinically meaningful positive outcomes for PD-L1 high-expressing, low-expressing, and even PD-L1-negative patient populations. Clinical benefit across multiple cancer types and tumor PD-L1 expression status shows that cadonilimab not only advances current cancer immunotherapies, but also significantly broadens their patient coverage. Cadonilimab holds the potential to become a cornerstone drug in the next generation of cancer immunotherapy and is expected to be widely used in combination with antibody-drug conjugates (ADCs) and other high-potential targets. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3ImmunotherapyAACRClinical Result

100 Deals associated with Capecitabine

External Link

KEGG	Wiki	ATC	Drug Bank
D01223	Capecitabine	L01BC06	DB01101

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Gastrooesophageal junction cancer	US	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Pancreatic Cancer	US	CHEPLAPHARM Arzneimittel GmbH	14 Dec 2022
Rectal Cancer	JP	Chugai Pharmaceutical Co., Ltd.	19 Sep 2016
Esophageal Carcinoma	AU	Dr. Reddy's Laboratories (Australia) Pty Ltd.	24 Jun 2013
Locally advanced breast cancer	EU	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	EU	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	EU	KRKA dd	20 Apr 2012
Locally advanced breast cancer	IS	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	IS	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	IS	KRKA dd	20 Apr 2012
Locally advanced breast cancer	LI	KRKA dd	20 Apr 2012
Locally advanced breast cancer	LI	Accord Healthcare SLU	20 Apr 2012
Locally advanced breast cancer	LI	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	NO	Teva Pharmaceuticals Europe BV	20 Apr 2012
Locally advanced breast cancer	NO	KRKA dd	20 Apr 2012
Locally advanced breast cancer	NO	Accord Healthcare SLU	20 Apr 2012
Stomach Cancer	CN	Chugai Pharmaceutical Co., Ltd.	17 Oct 2008
Breast cancer recurrent	JP	CHEPLAPHARM Arzneimittel GmbH	12 Dec 2007
Colonic Cancer	JP	Chugai Pharmaceutical Co., Ltd.	30 Apr 2003
Advanced gastric carcinoma	EU	CHEPLAPHARM Arzneimittel GmbH	02 Feb 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
ER-positive/HER2-negative Breast Cancer	Phase 3	FR	UNICANCER	11 Jun 2020
GRPR Positive/ER Positive/HER2 Negative Breast Cancer	Phase 3	FR	UNICANCER	11 Jun 2020
Metastatic gastric adenocarcinoma	Phase 3	US	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	JP	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	AR	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	BE	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	CA	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	CZ	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	DK	Eli Lilly & Co.	20 Jan 2015
Metastatic gastric adenocarcinoma	Phase 3	FI	Eli Lilly & Co.	20 Jan 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


PRODIGE83-ACABi-PRONOBIL (ASCO_GI2025)	Not Applicable	Biliary Tract Neoplasms Adjuvant	324	Capecitabine	tlzjdcomcu(eawyjknbef) = 27% of grade 3-4 twfjevgtsa (ukaeqlncoo ) View more	Positive	23 Jan 2025
				capecitabine (No adjuvant treatment)
NCT02451553 (Phase I/Ib study of afatinib with capecitabine, ASCO_GI2025)	Phase 1	Solid tumor \| Neoplasms EGFR amplified \| EGFR/HER2/HER3 pathway alterations	41	Afatinib 20 mg	clpxdyduyi(lhxhqklydr) = eygrxnwbzs ugebhnjmdn (vakhovislk ) View more	Negative	23 Jan 2025
				Afatinib 30 mg	clpxdyduyi(lhxhqklydr) = kfixmflefv ugebhnjmdn (vakhovislk ) View more
NCT02767661 (MECCA, Pubmed \| Literature) Manual	Phase 3	Hormone receptor positive HER2 negative breast cancer Hormone Receptor Positive \| HER2 Negative	254	metronomic capecitabine + an aromatase inhibitor	yiwhgswbjf(ovxsnmtctw) = tcoqifmkvz piphgibfav (qkublaymob ) View more	Positive	02 Jan 2025
				An aromatase inhibitor	yiwhgswbjf(ovxsnmtctw) = otgsdbmfnb piphgibfav (qkublaymob ) View more
NCT04324476 (Pubmed) Manual	Phase 2	Metastatic Colorectal Carcinoma	52	CAPOX/CAPIRI plus bevacizumab	nycrhgolht(tszvapuxdp) = fzqkahyrsr bijfhlowax (kgmykvppuk, 9.0 - 12.4) View more	Positive	11 Dec 2024
ESMO_ASIA2024	Not Applicable	Head and Neck Neoplasms	101	Capecitabine 2000 mg + Cyclophosphamide 100 mg	fsxhtxolvz(ckzoxwnuqf) = most patients experiencing manageable Grade 1 mucositis npyhcdkfdh (hddbvropae )	Positive	07 Dec 2024
ESMO_ASIA2024	Not Applicable	Colorectal Cancer	214	capecitabine (Age ≥60 years)	anjqcrgopv(zguxnayygf) = znvxfwiavz wgatdiedju (xzhwlabuht )	-	07 Dec 2024
				Capecitabine monotherapy	anjqcrgopv(zguxnayygf) = hbjbhxsodz wgatdiedju (xzhwlabuht )
NCT03487666 (CTgov)	Phase 2	Triple Negative Breast Cancer	45	Nivolumab (Arm A- Nivolumab)	gncypdswuy(puajsmkvay) = ksspcvdhds wbqffuisjg (wgipogndmc, wzzdndksdo - ogbvhlltqb) View more	-	03 Dec 2024
				Capecitabine (Arm B- Capecitabine)	gncypdswuy(puajsmkvay) = vmxfdqngea wbqffuisjg (wgipogndmc, zgfrdgqfpp - jxawxnntsc) View more
NCT03259035 (CCTG CO.28 \| NEO \| CO.28, CTgov)	Phase 2	Rectal Cancer	58	folinic acid+oxaliplatin+capecitabine+fluorouracil	jpmlncapuu(doxwqqnjgg) = ubzpklcsnl ovkotqvhvn (nmxqcnmvei, aeghszovyq - vtyriygbrv) View more	-	10 Oct 2024
NCT03691051 (PERMEATE, Pubmed \| EClinicalMedicine) Manual	Phase 2	HER2 Positive Breast Cancer HER2 Positive	78	Pyrotinib plus capecitabine	uqqpekhkpi(xfanpmbgwb) = orgwztyire iyifyrjzvu (nghdoajfnj, 24.4 - not reached) View more	Positive	01 Oct 2024
				Pyrotinibcapecitabine (Radiotherapy-naïve brain metastases)	uqqpekhkpi(xfanpmbgwb) = ndrgpmuvty iyifyrjzvu (nghdoajfnj, 12.6 - 33.3) View more
ASTRO2024	Not Applicable	Breast Cancer	-	Concurrent chemoradiotherapy with capecitabine 1000mg/m2 bid	arnyjpzmgt(zovdgpreqa) = None but 1 patient discontinued concurrent medication because of gastrointestinal reaction vrqxjxnxfx (jfgynhhvkw ) View more	-	01 Oct 2024
				Low-dose maintenance therapy with capecitabine 500mg tid

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis