drugset / Trial / NCT07315035
QL1706-SOX vs SOX Alone as Neoadjuvant Therapy for Resectable Diffuse-Type Gastric Cancer
Phase 2
Not yet recruiting
74 enrolled
The First Affiliated Hospital with Nanjing Medical University
First Affiliated Hospital of Suzhou Medical College · collabThe Affiliated Hospital of Xuzhou Medical University · collabThe Affiliated Jiangning Hospital of Nanjing Medical University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-01-01
- Primary completion
- 2028-12-31
- Completion
- 2030-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QL1706 | Monoclonal antibody | 5 mg/kg | Intravenous |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |
| Background | S-1 | Small molecule | 40 mg | Oral |
| Background | S-1 | Small molecule | 50 mg | Oral |
| Background | S-1 | Small molecule | 60 mg | Oral |