The Efficacy and Safety of Benmelstobart for GC/EGC
NCT06603974 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-09-19
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.
Conditions
Interventions
- 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
-
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
Sponsors & Collaborators
-
Xijing Hospital
lead OTHER
Principal Investigators
-
Liu Hong, master · Department of Digestive Surgery, Xijing Hospital, Air Force Medical University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-16
- Primary Completion
- 2026-07-26
- Completion
- 2026-12-26
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