QL1706-SOX vs SOX Alone as Neoadjuvant Therapy for Resectable Diffuse-Type Gastric Cancer

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.

NCT Number	NCT07315035
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
Conditions	Gastric Cancer Stage III
Enrollment	74 participants
Start Date	2026-01-01
Primary Completion	2028-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-02