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SHR-8068 plus Adebrelimab and Chemotherapy in Advanced Gastric and Esophageal Cancer
NCT06247956Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Mar 2024
- Primary completion
- Dec 2025
- Countries
- 1
- Modality
- Monoclonal Antibodies
- Drugs
- CS1002
- Conditions
- gastric adenocarcinomaEsophageal Squamous Cell Carcinoma (ESCC)
01
Overview
Phase 2, randomised, open-label trial of CS1002 in gastric adenocarcinoma and Esophageal Squamous Cell Carcinoma (ESCC) (2 arms), sponsored by Suzhou Suncadia Biopharmaceutical. Primary endpoint: Objective Response Rate up to 1 year. Started Mar 2024; status: active, not recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
SHR-8068 + Adebrelimab + Chemo
SHR-8068 combined with Adebrelimab and platinum-containing chemotherapy (Oxaliplatin/Capecitabine or Paclitaxel/Cisplatin).
Adebrelimab + Chemo
Adebrelimab combined with platinum-containing chemotherapy (Oxaliplatin/Capecitabine or Paclitaxel/Cisplatin).
03
Who it enrols
Adult patients (18-75 years) with histologically confirmed unresectable, advanced, or metastatic gastric/GEJ adenocarcinoma or esophageal squamous cell carcinoma. Must have measurable disease (RECIST v1.1) and ECOG PS 0-1. Excludes HER2-positive patients, those with untreated CNS metastases, active autoimmune disease, or prior organ transplant.
04
Endpoints
Primary
Objective Response Rate
Secondary
Disease Control Rate
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