NCT06603974

The Efficacy and Safety of Benmelstobart for GC/EGC

An Exploratory Study of Benmelstobart in Combination with Antiangiogenesis Drugs and Neoadjuvant Chemotherapy for Locally Progressive Gastric Cancer / Gastroesophageal Junction Carcinoma

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the major pathological response (MPR) rate of locally advanced gastric cancer / gastroesophageal junction cancer treated with bemosumab combined with antiangiogenic drugs and neoadjuvant chemotherapy. Researchers will use drug Benmelstobart in combination with antiangiogenesis drugs and newadjuvant chemotherapy to see if the drug works to treat locally advanced gastric cancer / gastroesophageal junction cancer. Participants will:injection drug Benmelstobart，On the first day of each cycle, 3 weeks (21 days) were a treatment cycle.

Detailed description

The phase i/ii clinical study of benmelstobart combined with anlotinib, oxaliplatin and capecitabine in the first-line treatment of gastric / gastroesophageal junction adenocarcinoma has shown good efficacy and safety. Anti vascular drugs have also shown excellent anti-tumor effects in the neoadjuvant treatment of locally advanced gastric cancer. Therefore, this study plans to explore the efficacy of benmelstobart combined with anti angiogenic drugs and neoadjuvant chemotherapy for locally advanced gastric cancer / gastroesophageal junction cancer, and make up for this part of the treatment gap.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
PROCEDURE	surgery	After receiving the corresponding neoadjuvant treatment for 2 cycles, surgery was performed within 3-6 weeks after drug withdrawal.
DRUG	Benmelstobart	1200mg, diluted to 250ml with normal saline, infusion time 60 ± 10mins. The first day of each cycle, 3 weeks (21 days) as a treatment cycle
DRUG	tegafur	it needs to be administered according to the patient\'s body surface area\< 40mg / time at 1.25m2; \> 50mg/ time for 1.25m2 and \<1.5m2; \> 60mg/ time at 1.5m2; Oral, twice a day, after morning and evening meals, for 14 consecutive days, rest for 7 days, as a treatment cycle; Repeat every 3 weeks;
DRUG	oxaliplatin	130mg/m2, administered on the first day of each cycle, repeated every 3 weeks;
DRUG	albumin paclitaxel	260mg/m2, intravenous infusion, 30 minutes per infusion, once every 3 weeks, administered on the first and eighth days of each cycle

Timeline

• Start date: 2024-10-16
• Primary completion: 2026-07-26
• Completion: 2026-12-26
• First posted: 2024-09-19
• Last updated: 2024-09-19