A Study of the Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction With Camrelizumab+SOX Control Camrelizumab+SOX+ Trastuzumab
- Sponsor
- Henan Cancer Hospital
- Study ID
- NCT05583383
- Status
- Unknown
Conditions
- Advanced Gastric Adenocarcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- camrelizumab — DRUGcamrelizumab was administered intravenously at a fixed dose of 200 mg, on the first day, once every 3 weeks, with a cycle of 3 weeks. Infusion for 30 min each time (no less than 20 min and no more than 60min); SOX: Oxaliplatin: 130 mg/m2, administered intravenously, on the first day, once every three weeks, and every three weeks is a cycle; S-1: according to BSA (\< \<1.25 40 mg;; 1.25-1.5 50 mg; \> \>1.5 60 mg), oral administration, d1-d14 twice a day, 3 weeks as a cycle; Trastuzumab was administered intravenously, with an initial loading dose of 8 mg/kg and a subsequent dose of 6 mg/kg, with a cycle of 3 weeks.
Study Details
A Study of the Advanced Adenocarcinoma of Stomach and Gastroesophageal Junction With Camrelizumab+SOX Control Camrelizumab+SOX+ Trastuzumab
Key Dates
- Start date
- Mar 31, 2022
- Status verified
- Oct 2022
- Primary completion
- Mar 31, 2025
- Completion
- Mar 31, 2025
Study Design
- Enrollment
- 62 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Cohort 1camrelizumab was administered intravenously at a fixed dose of 200 mg, on the first day, once every 3 weeks, with a cycle of 3 weeks. Infusion for 30 min each time (no less than 20 min and no more than 60min); SOX: Oxaliplatin: 130 mg/m2, administered intravenously, on the first day, once every three weeks, and every three weeks is a cycle; S-1: according to BSA (\< \<1.25 40 mg;; 1.25-1.5 50 mg; \> \>1.5 60 mg), oral administration, d1-d14 twice a day, 3 weeks as a cycle; Trazumab was administered intravenously, with an initial loading dose of 8 mg/kg and a subsequent dose of 6 mg/kg, with a cycle of 3 weeks
- Active Comparator: Cohort 2camrelizumab was administered intravenously at a fixed dose of 200 mg, on the first day, once every 3 weeks, with a cycle of 3 weeks. Infusion for 30 min each time (no less than 20 min and no more than 60min); SOX: Oxaliplatin: 130 mg/m2, administered intravenously, on the first day, once every three weeks, and every three weeks is a cycle; S-1: according to BSA (\< \<1.25 40 mg;; 1.25-1.5 50 mg; \> \>1.5 60 mg), oral administration, d1-d14 twice a day, 3 weeks as a cycle;
Primary Outcome Measure
Pathological complete response rate(pCR) [ Time Frame: up to 2 years ]
Central Contacts
- LiuYing LiuYing, Doctor13783604602
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