Flexible Ureteroscopy With Steerable Versus Conventional Flexible and Navigable Suction Ureteral Access Sheath (FANS) Utility in Less Than 2cm Lower Pole Stones Treatment: a Multicenter, Randomized Superiority Trial (SCULPT Trial)

This multicenter, randomized, controlled superiority trial (the SCULPT trial) aims to compare the efficacy and safety of a novel steerable flexible and navigable suction ureteral access sheath (FANS) versus the conventional FANS in the treatment of lower pole renal stones ≤2 cm. Lower pole stones are particularly challenging due to the narrow infundibular-pelvic anatomy that limits the maneuverability of standard FANS. The steerable FANS incorporates an active deflection mechanism that allows for independent control, potentially improving the success rate of accessing the lower pole calyx, performing laser lithotripsy, and aspirating stone fragments without additional adjuncts.
A total of 400 patients from 20 high-volume urological centers in China (approximately 20 patients per center) will be randomized in a 1:1 ratio to receive either steerable FANS or conventional FANS during flexible ureteroscopy. Primary outcome measures include the success rate of FANS navigation into the lower pole calyx as evidenced by direct stone visualization, effective laser lithotripsy, and successful stone aspiration. Secondary outcomes will assess immediate and 1-month stone-free rates, operative time, complication rates, instrument durability, and improvements in quality of life. This study is expected to provide critical evidence to guide clinical decision-making and potentially improve treatment efficiency for challenging lower pole renal stones.

Start Date16 Mar 2025

Sponsor / Collaborator

The First Affiliated Hospital of Guangzhou Medical University

[+6]

ChiCTR2500097618

/ SuspendedEarly Phase 1IIT

Efficacy of prolonged intravenous lidocaine for postoperative pain in patients undergoing laparoscopic hysterectomy: a double-blind, randomized, placebo-controlled trial

Start Date21 Feb 2025

Sponsor / Collaborator

Dongguan People's Hospital

100 Clinical Results associated with Dongguan People's Hospital

0 Patents (Medical) associated with Dongguan People's Hospital

901

Literatures (Medical) associated with Dongguan People's Hospital

01 May 2025·Journal of Hospital Infection

Impact of pretreatment strategies and cleaning methods on the cleaning efficacy of electrosurgical instruments: a multi-centre study

Article

Author: Ye, L-L ; Cai, Y-X ; Li, C-G ; Zhang, H ; Chen, A-Q ; He, Y-H ; Li, H ; Li, S-Y

OBJECTIVESTo investigate the impact of different pretreatment strategies and cleaning methods on the cleaning efficacy of electrosurgical instruments, with the aim of proposing an optimal protocol.METHODSIn total, 573 electrosurgical instruments were collected from three large-scale hospitals within 2 h of use between December 2023 and July 2024. The instruments were categorized into six groups: medical alkaline cleaner, multi-enzyme cleaner and instant foam-type multi-enzyme humectant followed by manual cleaning; and medical alkaline cleaner, multi-enzyme cleaner and instant foam-type multi-enzyme humectant followed by mechanical cleaning with a vacuum boiling washer. Cleaning quality was assessed through visual estimation, residual protein detection, and adenosine triphosphate (ATP) biological fluorescence detection.RESULTSVisual assessment indicated that different pretreatment and cleaning methods did not affect cleaning quality significantly (P>0.05). Residual protein detection analysis revealed that mechanical cleaning outperformed manual cleaning [adjusted odds ratio (AOR) 2.20, 95% confidence interval (CI) 1.18-4.11; P=0.013], with both medical multi-enzyme cleaners (AOR 3.72, 95% CI 1.11-12.44; P=0.033) and instant foam-type multi-enzyme humectants (AOR 3.27, 95% CI 1.07-10.03; P=0.038) combined with mechanical cleaning demonstrating superior performance. ATP detection confirmed that mechanical cleaning was more effective than manual cleaning (AOR 5.10, 95% CI 2.00-12.95; P<0.001), particularly when using a medical alkaline cleaner (AOR 6.79, 95% CI1.36-33.83; P=0.019) or a multi-enzyme cleaner (AOR 6.77, 95% CI 1.43-31.95; P=0.016) before mechanical cleaning.CONCLUSIONMechanical cleaning emerged as the critical factor for improving the cleaning efficacy of electrosurgical instruments, and no significant differences were observed between the three pretreatment strategies: medical alkaline cleaner, medical multi-enzyme cleaner, and instant foam-type multi-enzyme humectant. Furthermore, even electrosurgical instruments with complex structures maintain adequate cleanliness after standardized pretreatment and cleaning protocols.

25 Apr 2025·Cancer Research

Abstract CT011: Penpulimab versus placebo in combination with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A global, multicenter, randomized, double-blind, phase 3 trial (AK105-304)

Author: Lin, Qin ; Gu, Kangsheng ; Lin, Daren ; Hu, Xiaoye ; Yang, Haihua ; Chan, Kelvin KW ; Liu, Feng ; Jin, Feng ; Li, Jingao ; Wang, Zhongmin Maxwell ; Jiang, Yi ; Liu, Meilian ; Chen, Xiaozhong ; Bueno de Oliveira, Thiago ; Alves, Gustavo Vasconcelos ; Xia, Michelle ; Wang, Dongxia ; Xiang, Li ; Xu, Tingting ; Ding, Jianwu ; Zhang, Peng ; Li, Xiaojiang ; Wen, Jiyu ; Mak, Milena Perez ; Yao, Zhifang ; Huang, Xiaoming ; Qu, Shenhong ; Hu, Mingxiu ; Shreenivas, Aditya ; Wang, Siyang ; Qu, Song ; Wang, Rensheng ; Ai, Xiaohong ; Hu, Chunhong ; Lu, Dongmei ; Wang, Lin ; Hu, Chaosu ; Martins de Marchi, Pedro Rafael ; Pfister, David G. ; Wu, Dehua ; Huang, Shuang ; Hu, Desheng ; Chen, Yong ; Zhang, Jian ; Zhou, Ping ; Liu, Tianrun ; Chen, Lisha ; Baston Silva, Carlos Eduardo ; Li, Xianming ; Li, Baiyong

AbstractBackground:Studies have shown that the combination of PD-1 inhibitors with chemotherapy exhibits promising efficacy as a first-line treatment for Asian patients with recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). This presentation reports the results of a global phase 3 clinical trial with ethnically diverse patients treated with penpulimab plus chemotherapy vs. placebo plus chemotherapy as the first-line therapy for R/M NPC (NCT04974398).Methods:AK105-304 trial was conducted across 46 sites worldwide. Participants aged 18-75 years with previously non-systemically treated R/M NPC, stratified by disease stages (de novo metastases vs. recurrent), ECOG (0 vs. 1), liver metastasis (present vs. absent), were randomized (1:1) to receive penpulimab or placebo (200mg, Day1) in combination with gemcitabine (1000mg/m2, Day 1 and 8) and cisplatin (80mg/m2, Day1) or carboplatin (AUC5, Day1) every 3 weeks (Q3W) for up to 6 cycles, followed by maintenance therapy with penpulimab or placebo (200mg, Q3W). Placebo-arm patients were allowed to crossover to receive penpulimab monotherapy (200 mg, Q3W) upon confirmed disease progression by blinded independent center review (BICR). Primary endpoint was PFS assessed by BICR, and key secondary endpoint was OS. Other secondary endpoints included ORR, DoR and safety.Results:291 patients were randomized to penpulimab arm (n=144) or placebo arm (n=147). Baseline characteristics were generally balanced between treatment arms. By April 29, 2024, median follow-up time was 19.1 months. Per BICR assessment, median PFS was 9.6 months (95% CI: 7.1, 12.5) and 7.0 months (95% CI: 6.9, 7.3), respectively, for penpulimab+chemo and placebo+chemo (HR=0.45, 95% CI: 0.33, 0.62, two-sided P < 0.0001). Confirmed ORR was 68.1% vs. 63.9%, and median DoR was 9.8 months (95% CI: 7.0, 17.5) vs. 5.7 months (95% CI: 5.5, 6.7) (HR=0.4, 95%CI: 0.27, 0.59). OS was not mature, with 48 deaths in penpulimab arm and 49 in placebo arm (HR=0.94, 95% CI: 0.63, 1.40). After adjusting for crossover of patients from placebo to penpulimab upon PD, OS benefit became more evident, with HR of 0.62 (0.41, 0.94) by Rank Preserving Structural Failure Time (RPSFT) model, 0.75 (0.43, 1.30) by Inverse Probability of Censoring Weighting (IPCW) method, and 0.78 (0.52, 1.17) by two-stage Accelerated Failure Time (AFT) model. The incidence of Grade ≥3 TRAEs was 89.0% vs. 85.9%; SAEs was 50.7% vs. 48.6%; irAEs was 30.8% vs. 8.5%; Grade ≥3 irAEs was 4.1% vs. 0.Conclusions:Penpulimab combined with gemcitabine and cisplatin or carboplatin demonstrated statistically significant and clinically meaningful benefit with a manageable safety profile, and provides a new beneficial treatment option in the first-line treatment for R/M NPC patients globally.Citation Format:Chaosu Hu, Xiaozhong Chen, Tingting Xu, Shuang Huang, Feng Liu, Song Qu, Lisha Chen, Ping Zhou, Shenhong Qu, Xiaohong Ai, Yong Chen, Meilian Liu, Rensheng Wang, Kelvin KW Chan, Peng Zhang, Chunhong Hu, Jiyu Wen, Jian Zhang, Qin Lin, Xiaojiang Li, Kangsheng Gu, Li Xiang, Dongxia Wang, Jingao Li, Daren Lin, Desheng Hu, Jianwu Ding, Siyang Wang, Xiaoming Huang, Lin Wang, Feng Jin, David G. Pfister, Milena Perez Mak, Pedro Rafael Martins de Marchi, Yi Jiang, Haihua Yang, Xiaoye Hu, Tianrun Liu, Dehua Wu, Aditya Shreenivas, Thiago Bueno de Oliveira, Carlos Eduardo Baston Silva, Gustavo Vasconcelos Alves, Xianming Li, Zhifang Yao, Dongmei Lu, Mingxiu Hu, Zhongmin Maxwell Wang, Baiyong Li, Michelle Xia. Penpulimab versus placebo in combination with chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma: A global, multicenter, randomized, double-blind, phase 3 trial (AK105-304) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_2):Abstract nr CT011.

21 Apr 2025·Cancer Research

Abstract 4686: Efficacy and safety of efbemalenograstim alfa as primary prophylaxisfor concurrent chemo-radiotherapy induced neutropenia

Author: Li, Qiwen ; Wen, Zunbei ; Huang, Rong ; Chen, Yuanyuan ; Zhang, Xuefang ; Ji, Yongling ; Wang, Chen ; Lai, Shuzhen ; Chen, Ming ; Ouyang, Yi ; Li, Minying

Background:Concurrent chemo-radiotherapy (CCRT) occupies a pivotal position in the therapeutic management of various malignant tumors and frequently causes significant hematologic toxicity, particularly leukopenia and neutropenia. Nonetheless, granulocyte-macrophage colony-stimulating factor (GM-CSF) is not recommended for preventing CCRT, while granulocyte colony-stimulating factor (G-CSF) is seldom investigated in this setting. This study aims to evaluate the effectiveness and safety of efbemalenograstim alfa, a novel long-acting G-CSF, as a primary prophylaxis during CCRT.Method:This multicenter, open-label, randomized controlled trial will enroll 120 patients who are scheduled to undergo definitive CCRT for malignancies, including non-small cell lung cancer, small cell lung cancer, esophageal cancer, nasopharyngeal carcinoma, head and neck squamous cell carcinoma, or cervical cancer. Patients will be randomized 1:1 to study group or control group. In the study group, patients will receive efbemalenograstim alfa approximately 48 hours post-chemotherapy. In the control group, patients will receive rhG-CSF upon an absolute neutrophil count (ANC) drop below 1.0 × 109/L. Patients who developed febrile neutropenia (FN) or dose-limiting neutropenic event in the control group will receive efbemalenograstim alfa in the subsequent chemotherapy cycles. The primary endpoint is the incidence of 3/4 grade neutropenia (ANC < 1.0 × 109/L) throughout the CCRT period.Result:Efbemalenograstim alfa administration significantly reduced the incidence of grade 3/4 neutropenia during the CCRT period. Four patients (12.90%) in the efbemalenograstim alfa group experienced grade 3/4 neutropenia, compared to 14 (45.16%) in the control group, resulting in a difference of -32.26% (90% CI: -49.20%, -13.66%, p= 0.0035). The incidence of grade 3/4 neutropenia was 9.68% (study group) vs 45.16% (control group) (p=0.0009) across first chemotherapy cycle, and 3.23% (study group) vs 16.13% (control group) (p=0.0881) across second cycle. Efbemalenograstim alfa administration also resulted in shorter duration of grade 3/4 neutropenia, with a median duration of 0 day (IQR: 0-0) in study group and 0 day (IQR: 0-5) in control group (p=0.008). The depth of ANC nadir is higher in study group than that in control group (3.19 (0.26-8.45) × 109/L vs 1.00 (0.06-4.43) × 109/L, p < 0.001), the mean difference was 2.10 (1.39, 2.71) × 109/L. Efbemalenograstim alfa was well-tolerated, as no≥3 grade treatment-related adverse event (TRAE) was reported in both group. The most common treatment-emergent AEs in study group included thrombocytopenia (48.39%), anemia (45.16%) and hypokalemia (35.48%).Conclusion:Primary prophylaxis with efbemalenograstim alfa provide effective neutrophil support to patients undergoing CCRT, with good safety.Citation Format:Yuanyuan Chen, Qiwen Li, Zunbei Wen, Yi Ouyang, Shuzhen Lai, Rong Huang, Minying Li, Xuefang Zhang, Yongling Ji, Chen Wang, Ming Chen. Efficacy and safety of efbemalenograstim alfa as primary prophylaxisfor concurrent chemo-radiotherapy induced neutropenia [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4686.

News (Medical) associated with Dongguan People's Hospital

29 Nov 2024

·www.prnewswire.com

Minghui Pharmaceutical Announces Positive Topline Results from Phase Ⅲ Trial of MH004 (Tofacitinib Etocomil) Ointment in Mild to Moderate Atopic Dermatitis

SHANGHAI, Nov. 29, 2024 /PRNewswire/ -- Minghui Pharmaceutical, a late-stage biopharmaceutical company dedicated to developing transformative medicines in immunology and oncology, today announced positive topline results from its phase Ⅲ trial of MH004 (tofacitinib etocomil) ointment 1.0%, a twice-daily pan-Jak inhibitor, in adolescents (ages 12 years and older) and adults with mild to moderate atopic dermatitis (AD). This multicenter, double-blind, randomized, vehicle-controlled phase Ⅲ clinical trial was conducted to evaluate the efficacy and safety of MH004 1.0% in adolescents and adults with mild to moderate AD. A total of 377 participants were randomized 2:1 to receive either MH004 1.0% or Vehicle BID with an 8-week treatment period, followed by 44-week open-label extension for long-term safety. The primary endpoints were the proportion of participants achieving IGA-TS (Investigator Global Assessment (IGA) of 'clear' or 'almost clear' with a 2-grade improvement) at Week 4 and the proportion achieving a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 4. Key efficacy results are as follows: IGA-TS at Week 4 41.0% of individuals treated with MH004 1.0% achieving IGA-TS at Week 4 compared to 10.3% treated with vehicle (P<0.0001). EASI-75 at Week 4 58.2% of individuals treated with MH004 1.0% achieving EASI-75 at Week 4 compared to 19.8% treated with vehicle (P<0.0001). Additionally, the key secondary endpoints, including IGA-TS and EASI-75 at week 8, as well as the proportion of participants with a ≥ 4-point improvement in Itch Numerical Rating Scale (NRS4) score at week 8, were successfully met. MH004 1.0% demonstrated statistically significant improvements across all these parameters compared to the vehicle. MH004 1.0% was well-tolerated, with a safety profile consistent with findings from the previous Phase II study. All TRAEs were mild to moderate (grade 1 or 2) in severity. No drug-related serious adverse events (SAEs) were reported. "We are thrilled with the positive topline results from the Phase Ⅲ study. MH004 showed significant symptom improvement in patients with atopic dermatitis and was well-tolerated." said Guoqing Cao, Ph.D., Chief Executive Officer of Minghui Pharmaceutical. "The rapid onset of action observed with MH004 is particularly valuable for patients. These findings reinforce MH004's potential as a meaningful addition to current treatment options for atopic dermatitis, addressing both safety and efficacy needs. Moreover, MH004's benefits may extend to other inflammatory skin diseases as well. In our ongoing phase Ⅱ for vitiligo, we have seen convincing PoC, and the preliminary efficacy data looks highly encouraging." Dr. Cao continued, "I would like to extend my sincere gratitude to all the patients who participated in the trial, as well as to the physicians and staff for their dedicated work. Their contributions were essential to the success of this trial. We look forward to working with regulators to make this treatment available to patients as soon as possible." "Atopic dermatitis is a chronic inflammatory condition, particularly prevalent in children, underscoring the urgent need for effective, fast-acting topical therapies beyond corticosteroids." said Jianzhong Zhang, M.D., lead investigator in the Phase 3 trial and Professor of Peking University People's Hospital. "While corticosteroids are reasonably effective, their long-term use is often limited due to local side effects and safety concerns. MH004 demonstrated superior clinical efficacy in this pivotal phase Ⅲ study, achieving the co-primary endpoints of IGA-TS and EASI-75. The treatment also exhibited a favorable safety profile, and as the leading PI of this study, I am highly encouraged by these results and optimistic about MH004's potential to advance AD care." About Minghui Pharmaceutical Minghui Pharmaceutical, established in 2018, is a late-stage biopharmaceutical company committed to developing innovative therapies for unmet medical needs in oncology and autoimmune diseases. Leveraging expertise in medical science and proprietary technology platforms, the company is advancing a robust clinical-stage pipeline that features a range of first-in-class or best-in-class product candidates. For more information, please visit . About MH004 Ointment MH004 (tofacitinib etocomil) ointment is a topical product containing a JAK inhibitor that was designed and formulated with Minghui's proprietary technologies. MH004 is expected to have much improved skin permeability to achieve extensive target inhibition in local skin tissues without systemic toxicities that have been widely reported for oral JAK inhibitors. MH004 is intended to be used for the treatment of multiple dermatologic autoimmune diseases. Forward-Looking Statements This press release provided by Minghui Pharmaceutical Inc. (the "Company") contains forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, which may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "possible," "predict," "should," "will," "would" or words of similar meaning. These statements are based on the Company's current beliefs and expectations and subject to risks and uncertainties that may cause actual results to differ materially from those set forth in the statements herein. Risks and uncertainties include but not limited to: general industry conditions and competition; changes in economic and financial conditions of the Company's and the collaborators' businesses; the risk that clinical trials are discontinued or delayed for any reasons, including for efficacy, safety, enrollment, or manufacturing; the risk that success in early stage clinical trials may not be predictive of results in later stage trials or trials of other potential indications; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials; expectations for regulatory approvals; challenges to obtain, maintain and enforce patents and other intellectual property protection for the Company's product(s) and product candidate(s). These forward-looking statements speak only as of the date they are posted to this website, and the Company undertakes no obligation to update any forward-looking statements contained herein. SOURCE Minghui Pharmaceutical, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2

100 Deals associated with Dongguan People's Hospital

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CN117603382	Neoplasms More	Discovery
Anti-CD19 CAR T-cell therapy(Shenzhen Institute For Innovation & Translational Medicine) ( CD19 )	CD19 Expressing Malignancies More	Pending

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