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SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis
NCT07384234Phase 2
Key facts
- Status
- Recruiting
- Start
- Apr 2026
- Primary completion
- Dec 2028
- Countries
- 1
- Sponsor
- Ruijin Hospital
- Modality
- Fc-Fusion Proteins
- Drugs
- retlirafusp alfa
- Conditions
- gastric adenocarcinomagastroesophageal junction adenocarcinoma
01
Overview
Phase 2, randomised trial of retlirafusp alfa in gastric adenocarcinoma and gastroesophageal junction adenocarcinoma (2 arms), sponsored by Ruijin Hospital. Primary endpoint: 2-year overall survival rate. Started Apr 2026; status: recruiting.
02
Design
2 arms- Study design
- Randomized
SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1
SHR-1701 1800mg Q3W + S-1 Q3W + Paclitaxel Q3W
SHR-1701 and CAPOX
SHR-1701 1800mg Q3W + Capecitabine Q3W + Oxaliplatin Q3W
03
Who it enrols
Adults with previously untreated, HER2-negative gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis and ECOG 0-1.
04
Endpoints
Primary
2-year overall survival rate
Secondary
Conversion surgery rate
R0 resection rate
Pathological complete response
Tumor regression grade
Event free survival
Disease-free survival
Overall survival
Adverse events
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