NCT07315035

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

A Randomized, Controlled, Phase-II Trial of Neoadjuvant QL1706 (Iparomlimab /Tuvonralimab) Combined With SOX Versus SOX Alone Followed by Curative Gastrectomy in Patients With Locally Advanced Diffuse-Type Gastric Adenocarcinoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer Stage III

Interventions

Type	Name	Description
DRUG	QL1706 (Iparomlimab/Tuvonralimab)	QL1706 is a first-in-class, fixed-ratio bispecific monoclonal antibody produced in a single Chinese hamster ovary cell line that simultaneously targets PD-1 (IgG4 framework) and CTLA-4 (IgG1 framework) with an approximate 2:1 molar ratio. This molecular design delivers dual immune checkpoint blockade in one infusion, distinguishing it from separate-agent combinations such as nivolumab plus ipilimumab. In this study QL1706 is given at 5 mg/kg (actual body weight) as a 60-minute intravenous infusion on day 1 of each 21-day cycle, immediately followed by oxaliplatin 130 mg/m² (2-hour infusion) and oral S-1 (40-60 mg bid days 1-14). The sequence is repeated for 3-4 cycles before planned surgery; no intra-patient dose escalation or reduction is allowed, but infusion may be delayed ≤12 weeks for immune-related adverse events. The comparator arm receives identical SOX chemotherapy without any investigational antibody, ensuring that any difference in pathological outcome can be attributed spec
DRUG	SOX Chemotherapy	SOX chemotherapy consists of oxaliplatin 130 mg/m² delivered as a 2-hour intravenous infusion on day 1 plus oral S-1 (tegafur 40-60 mg, gimeracil and oteracil potassium in fixed 1:0.4:1 molar ratio) taken twice daily on days 1-14 of a 21-day cycle, repeated for 3-4 cycles before curative-intent gastrectomy. The S-1 dose is calculated by body-surface area: \<1.25 m² → 40 mg, 1.25-1.5 m² → 50 mg, \>1.5 m² → 60 mg per administration.

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-12-31
• Completion: 2030-12-31
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: China