Delving into the Latest Updates on Raltitrexed with Synapse

This is a prospective, multicentre, cohort study. For cohort 1, experimental cohort, older or Frail patients with inoperable localized colorectal cancer will receive Ultrafractionated Radiotherapy (RT) and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. All patients will receive Ultrafractionated RT and PD-1 antibody. Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive Fluorouracil/Raltitrexed and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.
For cohort 2, external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected.
The primary endpoint is complete response (CR, pathological complete response [pCR] plus clinical complete response [cCR]) rate. The secondary endpoints include the grade 3-4 acute adverse effects rate, anal preservation rate, survival etc.

Start Date01 Nov 2024

Sponsor / Collaborator

Fudan University

NCT06665087 / Not yet recruitingPhase 2IIT

Comprehensive Geriatric Assessment (CGA) Guided Ultrafractionated Radiotherapy and First-line Systemic Treatment in Elderly or Frail Patients with Metastatic Colorectal Cancer

This is a prospective, multicentre, cohort study. For cohort 1(CGA cohort), experimental cohort, older or Frail patients with metastatic colorectal cancer will receive Ultrafractionated Radiotherapy (RT) and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. All patients will receive Ultrafractionated RT and PD-1 antibody. Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive single agent chemotherapy, with/without targeted therapy, and BSC; Fit patients will receive doublet chemotherapy, with/without targeted therapy, and BSC.
For cohort 2 (external control cohort), external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected.
The primary endpoint is Progression Free Survival (PFS). The secondary endpoints include the grade 3-4 acute adverse effects (AE) rate, quality of life (QoL), the Overall Response Rate (ORR), 1-year Disease-specific survival (DSS) rate, 1-year overall survival (OS) rate etc.

Start Date01 Nov 2024

Sponsor / Collaborator

Fudan University

NCT06475287 / Not yet recruitingPhase 2IIT

The Efficacy and Safety of HAIC Combined With TQB2450 and Anlotinib in Second-line Treatment of Advanced Hepatocellular Carcinoma: an Open, Single Arm Exploratory Study

Overall, although there are many options for second-line treatment of liver cancer, the ORR is mostly limited to within 20-30%, with a median PFS of 3-5 months and a median OS of 10-20 months. The overall situation is still unsatisfactory, with low objective tumor response rates and targeted immune resistance being the main reasons affecting treatment efficacy. Increasing local treatment or overcoming resistance is currently a hot research topic. The aim of this study is to explore the effectiveness and safety of HAIC combined with TQB2450 and anlotinib for second-line treatment of advanced HCC patients.

Start Date20 Jul 2024

Sponsor / Collaborator

Fudan University

100 Clinical Results associated with Raltitrexed

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100 Translational Medicine associated with Raltitrexed

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100 Patents (Medical) associated with Raltitrexed

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Literatures (Medical) associated with Raltitrexed

01 Oct 2024·Alternative therapies in health and medicine

Safety Study of Raltitrexed Perfusion in Elderly Patients with Colorectal Cancer and Effect on CEA mRNA in Peritoneal Lavage Fluid.

Article

Author: Li, Jing ; Xie, Bo ; Wang, Yuanyuan ; Wang, Hu ; Jia, Jianguang

BackgroundIntraperitoneal chemotherapy is an effective way to kill free tumor cells in the abdominal cavity. The safety and efficacy of raltitrexed perfusion during radical surgery for elderly patients with colorectal cancer are still unclear.MethodsIn accordance with computer-generated random allocation sequences, 116 elderly patients with colorectal cancer who received radical surgery were randomly grouped into the raltitrexed intraperitoneal perfusion group or the saline intraperitoneal perfusion group from January 2020 to December 2021 in the First Affiliated Hospital of Bengbu Medical University. t tests and χ2 tests were used to analyze the difference between the two groups of the clinical characteristics, pathological features, perioperative parameters, and carcinoembryonic antigen mRNA in the peritoneal lavage fluid.ResultsNo statistically significant differences in postoperative complications after radical surgery were observed between the two groups. No statistically significant differences in peripheral blood indexes were observed between the two groups before surgery or on the first and third days after surgery. One day after radical surgery, the alanine transaminase (54.33 ± 4.93 vs 51.01 ± 5.56) and aspartate transaminase (49.28 ± 4.30 vs 50.99 ± 3.88) in the peripheral blood were higher in the raltitrexed intraperitoneal perfusion group than in the saline intraperitoneal perfusion group. At the same time, no significant difference was found on the third day after surgery. No significant differences in side effects of chemotherapy were observed between the two groups. The positive rate of carcinoembryonic antigen mRNA in the raltitrexed intraperitoneal perfusion group (8.47%) was significantly lower than that in the saline intraperitoneal perfusion group (22.81%) after surgery.ConclusionRaltitrexed perfusion during radical surgery is safe and feasible for elderly patients with CRC and can reduce the positive rate of carcinoembryonic antigen mRNA in peritoneal lavage fluid, so it can be explored as a treatment option.

19 Sep 2024·European journal of medical research

Efficacy of hepatic arterial infusion chemotherapy in patients with primary liver cancer with portal vein tumor thrombosis: a comparative analysis of different perfusion chemotherapeutic regimens.

Article

Author: Li, Yue ; Li, Sipeng ; Zhang, Wenfeng ; Tu, Xinxin ; He, Qi

BACKGROUNDPortal vein tumor thrombosis (PVTT) commonly occurs in patients with primary liver cancer (PLC). Transarterial chemoembolization (TACE) is a treatment for patients with PLC and PVTT. Some studies have shown that combining TACE therapy with hepatic arterial infusion chemotherapy (HAIC) might improve the survival rate of PLC patients with PVTT. However, few studies have compared the different regimens of PLC with PVTT. We aimed to compare the differences between the oxaliplatin + raltetrexed regimen and FOLFOX regimen.METHODSWe divided the 248 patients into two groups. There were 60 patients in the oxaliplatin + ratitetrexed group and 74 patients in the FOLFOX group. The primary endpoints were OS and PFS. The secondary endpoints were ORR and adverse events. We used SPSS software, the Kaplan-Meier method, the t test, and the rank sum test to compare the differences between the two groups.RESULTSThe median OS was 10.82 months in the oxaliplatin + raltitrexed group and 8.67 months in the FOLFOX group. The median PFS time was greater in the oxaliplatin + raltitrexed group (10.0 months) than that in the FOLFOX group (7.1 months). The ORR was greater in the oxaliplatin + raltitrexed group than that in the FOLFOX group (18.3% vs. 13.5%; P = 0.445). The DCR in the oxaliplatin + raltitrexed group was higher than that in the FOLFOX group (70.0% vs. 64.8%; P = 0.529). However, in the subgroup analysis, the difference between them was more significant in the type II PVTT subgroup. The OS was 12.08 months in the oxaliplatin + raltitrexed group and 7.26 months in the FOLFOX group (P = 0.008). The PFS was 11.68 months in the oxaliplatin + raltitrexed group and 6.26 months in the FOLFOX group (P = 0.014). In the right branch of type II PVTT, the OS was 13.54 months in the oxaliplatin + raltitrexed group and 6.89 months in the FOLFOX group (P = 0.015), and the PFS was 13.35 months in the oxaliplatin + raltitrexed group and 6.27 months in the FOLFOX group (P = 0.030). The incidence of adverse reactions was similar between the two groups.CONCLUSIONSCompared with the FOLFOX regimen, the oxaliplatin + raltitrexed chemoembolization regimen had longer OS, PFS time and ORR and DCR and it was safe and tolerable.

01 Sep 2024·Journal of Evidence-Based Medicine

Efficacy and safety of RS plus bevacizumab versus RS plus fruquintinib as the third‐line therapy in patients with refractory metastatic colorectal cancer: A real‐world propensity score matching study

Article

Author: Cao, Peng ; Qiu, Meng ; Xu, Qian ; Chen, Ye ; Zhou, Yuwen ; Leng, Wei‐Bing ; Luo, De‐Yun ; Wang, Jialing ; Liu, Jiyan

AbstractBackgroundThis study aims to compare the effectiveness and safety of the combination of raltitrexed, S‐1 (RS), and fruquintinib with the combination of RS and bevacizumab in patients with refractory metastatic colorectal cancer (mCRC).MethodsThis retrospective cohort included mCRC patients who received the RS plus fruquintinib or regorafenib as the third‐line therapy from May 2019 to April 2023. A propensity score matching (PSM) analysis was used to balance the baseline characteristics of all patients. Overall survival (OS), progression‐free survival (PFS), tumor response, and safety of the two regimens were evaluated.ResultsOf the 153 patients enrolled, 123 patients received the RS plus bevacizumab and 30 patients received the RS plus fruquintinib. After PSM, 30 pairs were analyzed. Patients treated with RS plus fruquintinib had a longer PFS than those treated with RS plus bevacizumab before PSM (5.0 months vs. 4.3 months, p = 0.008) and after PSM (5.0 months vs. 4.4 months, p = 0.012). A longer OS was also observed in RS plus fruquintinib group before PSM and after PSM, but there was no statistic difference between two groups after PSM. Both objective response rate and disease control rate were higher in the RS plus fruquintinib cohort than those in the RS plus bevacizumab cohort before PSM, and the difference in values between the two groups reduced after PSM. The adverse effects (AEs) of both groups were well tolerated.ConclusionIn patients with refractory mCRC, RS plus fruquintinib demonstrated a superior OS, PFS than RS plus bevacizumab and had manageable AEs.

100 Deals associated with Raltitrexed

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KEGG	Wiki	ATC	Drug Bank
D01064	Raltitrexed	L01BA03	DB00293

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Colorectal Cancer	AU	Pfizer Australia Pty Ltd.	15 Jul 1996

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Colorectal Liver Metastases	Discovery	FR	Hospira, Inc.	15 Dec 2010
Liver metastases	Discovery	FR	Hospira, Inc.	15 Dec 2010
Colorectal Cancer	Discovery	ES	AstraZeneca PLC	01 Nov 2003
Rectal Cancer	Discovery	TR	AstraZeneca PLC	01 Aug 2002

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03053167 (Pubmed \| BMC Cancer) Manual	Phase 2	Colorectal Cancer Second line	108	Raltitrexed+Irinotecan	(ichjgxyndl) = xwufuwvdzs eoihchazuy (kbdvfqkvin, 4.1 - 5.7) View more	Positive	02 Sep 2024
CSCO2022	Not Applicable	Colorectal Cancer	92	榄香烯乳状注射液联合雷替曲塞腹腔热灌注化疗	cpiksxnbxx(xrgehanodg) = 治疗后研究KPS评分高于对照组 ylbtaaehoy (nlewnvlfuo )	-	21 Sep 2022
				雷替曲塞腹腔热灌注+XELOX方案
NCT03126071 (ESMO2022) Manual	Phase 2	Metastatic Colorectal Carcinoma Second line	100	Bevacizumab 7.5mg/kg+Raltitrexed 3mg/m2+Irinotecan 200 mg ⁄m2 or oxaliplatin 130mg⁄m2	(diteusqgwb) = bzextslmxq smdfzsyehr (kwzzbobgwm, 5.1 - 9.4) View more	Positive	10 Sep 2022
ChiCTR1800016185 (ASCO2022) Manual	Phase 4	Metastatic Colorectal Carcinoma Second line	1,039	irinotecan+raltitrexed+target therapy	(tyyfrvibsz) = ccjtgchtlq gcuppkuvlb (vheeaxgmnb, 7.0 - 7.7) View more	Positive	02 Jun 2022
				irinotecan+raltitrexed	(tyyfrvibsz) = yonlewqiyx gcuppkuvlb (vheeaxgmnb, 4.7 - 5.7) View more
Pubmed Manual	Phase 2	Colorectal Cancer	30	Radiotherapy+Raltitrexed+Irinotecan Hydrochloride	(vqtjoygvyn) = uvzdqbqgrh zuowypddaq (ccbchkynrc ) View more	Positive	01 Jun 2022
CSCO2020	Phase 2	Metastatic Colorectal Carcinoma Second line	35	Irinotecan + Raltitrexed	(cazhqokgiw) = cljizovdam gvhbqgvstp (kymlfprvnv ) View more	-	19 Sep 2020
CSCO2020	Not Applicable	Colonic Cancer	-	奥沙利铂+卡培他滨	(lbevewdmht) = ugkpowfxgt hfqhbvzqhl (lmxdbtehuo )	Positive	19 Sep 2020
				伊立替康+雷替曲塞	(lbevewdmht) = lyxowixrsk hfqhbvzqhl (lmxdbtehuo )
AGEO multicentre (ESMO2020)	Not Applicable	Metastatic Colorectal Carcinoma First line	74	Raltitrexed	fotlndpkiy(bvngfysqhy) = 31% of patients had grade 3-4 side effects, regardless of the addition of bevacizumab (29% vs 32% without) vprikbtsln (cyyptfyzpv )	-	17 Sep 2020
				TOMOX
NCT02072317 (ASCO2019) Manual	Phase 2	stomach adenocarcinoma Second line	148	paclitaxel+raltitrexed	(krdygveuso) = vroplmltmc pghhmwyphs (qmvwlffrho ) View more	Positive	03 Jun 2019
				paclitaxel	(krdygveuso) = ibcswvcmos pghhmwyphs (qmvwlffrho ) View more
NCT03344614 (ASCO2019) Manual	Phase 2	Metastatic Colorectal Carcinoma Third line	31	Apatinib+Raltitrexed	(zlmimbbesu) = kpliiaiwvw rzrzesumjs (jtzfkogssr ) View more	Positive	31 May 2019