A Clinical Study of Iparomlimab and Tuvonralimab Combined With SOX Following Heterogeneous Radiotherapy as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Gastric or Gastroesophageal Junction Adenocarcinoma

Sponsor
Huazhong University of Science and Technology
Study ID
NCT07502027
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Gastric Cancer (Diagnosis)
  • Gastric Cancer (GC)
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Iparomlimab and Tuvonralimab (QL1706) — DRUG
    anti-PD-1/anti-CTLA-4 dual immunotherapy

Study Details

This study is a domestic, multicenter, single-arm clinical trial designed to evaluate the efficacy and safety of heterogeneous radiotherapy (high and low dose) sequenced with iparomlimab and tuvonralimab plus SOX as a first-line treatment for unresectable locally advanced or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.

Key Dates

First listed
Mar 30, 2026
Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Immunotherapy Combined with SOX Chemotherapy Following Radiation Therapy
    Radiation Therapy Dosage and Subsequent Treatment Regimen The radiation therapy (RT) dosage is specified as follows: For the primary tumor or main recurrent lesion: Radiation therapy at 3 Gy per fraction (F), totaling 10 fractions, administered 5 days per week. For major metastatic lesions: Radiation therapy at 2 Gy per fraction (F), totaling 1 fraction. One week after the completion of radiation therapy, iparomlimab and tuvonralimab plus SOX chemotherapy will be initiated. The planned regimen is as follows: Iparomlimab and tuvonralimab: 5 mg/kg (dose for the combined immunotherapy). SOX chemotherapy: Oxaliplatin 130 mg/m² via intravenous infusion (iv) on Day 1 (d1) + Tegafur/Gimeracil/Oteracil Potassium 40-60 mg orally (po) twice daily (bid) from Day 1 to Day 14 (d1-14). Treatment cycle: 21 days per cycle.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 1 year ]

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