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

NCT07315035 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2026-01-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • First Affiliated Hospital of Suzhou Medical College

    collaborator OTHER

  • The Affiliated Hospital of Xuzhou Medical University

    collaborator OTHER

  • The Affiliated Jiangning Hospital of Nanjing Medical University

    collaborator OTHER

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07315035 on ClinicalTrials.gov