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QL1706 + SOX in Locally Advanced Gastric or GEJ Adenocarcinoma
NCT06829797Phase 2
Key facts
- Status
- Recruiting
- Start
- Mar 2025
- Primary completion
- Feb 2028
- Countries
- 1
- Sponsor
- Shandong Provincial Hospital Affiliated to Shandong First Medical University
- Modality
- Monoclonal Antibodies, Fc-Fusion Proteins
- Conditions
- gastric adenocarcinomagastroesophageal junction adenocarcinoma
01
Overview
Phase 2, randomised, open-label trial of iparomlimab + tuvonralimab in gastric adenocarcinoma and gastroesophageal junction adenocarcinoma (2 arms), sponsored by Shandong Provincial Hospital Affiliated to Shandong First Medical University. Primary endpoint: Pathological complete response rate. Started Mar 2025; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
QL1706+SOX group
Neoadjuvant QL1706+SOX (4 cycles) -> Radical surgery (D2) -> Adjuvant QL1706+SOX (4 cycles)
SOX group
Neoadjuvant SOX (4 cycles) -> Radical surgery (D2) -> Adjuvant SOX (4 cycles)
03
Who it enrols
Adults aged 18-75 with previously untreated, locally advanced (T3N+ or T4a any N, M0) gastric or GEJ adenocarcinoma, ECOG 0-1, and expected survival >=12 months. Excludes HER2-positive patients, those with peritoneal metastases, active autoimmune diseases, or significant bleeding risks.
04
Endpoints
Primary
Pathological complete response rate
Secondary
Major pathological response rate
R0 resection rate
Event-free survival
Overall survival
Disease-free survival
Surgical safety
Adverse Events
Drug tolerance
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