NCT03950271

SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma

Phase II Clinical Study of PD1 Antibody (SHR-1210) Combined With Trastuzumab, Oxaliplatin and Capecitabine for Neoadjuvant Therapy of Gastric Adenocarcinoma/Gastroesophageal Junction Adenocarcinoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to observe the efficacy and safety of immume checkpoint inhibitor PD-1 SHR1210 combined with Trastuzumab , Oxaliplatin and Capecitabine for Neoadjuvant Therapy of locally advanced resectable gastric and gastroesophageal junction adenocarcinoma.

Detailed description

This study is a prospective, one-arm, phase II clinical study to evaluate the safety and efficacy of SHR-1210 in combination with trastuzumab plus oxaliplatin and capecitabine for HER2-positive locally advanced resectable gastric adenocarcinoma and gastroesophageal junction adenocarcinoma during the perioperative treatment.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine	1. Neoadjuvant chemotherapy： SHR-1210 (200mg, d1, q3w) + trastuzumab ( 8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks) + capecitabine (1000mg/m2 bid d2-15, q3w) + Oxaliplatin (130mg/m2, d2, q3w)；4cycle 2. postoperative adjuvant chemotherapy： Capecitabine (1000mg/m2 bid d1-14, q3w) + oxaliplatin (130mg/m2, d1, q3w)；The total number of chemotherapy cycles is 8 cycles.

Timeline

• Start date: 2020-01-20
• Primary completion: 2024-01-31
• Completion: 2026-12-31
• First posted: 2019-05-15
• Last updated: 2024-02-28

Locations

1 site across 1 country: China