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 — DRUG
    camrelizumab 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 1
    camrelizumab 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 2
    camrelizumab 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

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