QL1706-SOX vs SOX Alone as Neoadjuvant Therapy for Resectable Diffuse-Type Gastric Cancer
Status:
NOT_YET_RECRUITING
Trial end date:
2030-12-31
Target enrollment:
Participant gender:
Summary
The goal of this randomized, open-label, phase II clinical trial is to determine whether adding the PD-1/CTLA-4 bispecific antibody QL1706 to standard SOX chemotherapy increases the pathological complete response rate in adults aged 18-75 years with resectable, locally advanced, diffuse-type, HER2-negative gastric adenocarcinoma (cT3-4aNxM0). Participants will be randomly assigned (1:1) to receive 3-4 neoadjuvant cycles of QL1706 plus SOX or SOX alone every 3 weeks, followed by curative-intent gastrectomy with D2 lymphadenectomy, and will be monitored post-operatively every 3 months for 2 years and every 6 months thereafter for recurrence, survival, and safety.
Phase:
PHASE2
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborators:
First Affiliated Hospital of Suzhou Medical College The Affiliated Hospital of Xuzhou Medical University The Affiliated Jiangning Hospital of Nanjing Medical University