The goal of this Phase II clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 plus Oxaliplatin) in patients with previously untreated advanced or metastatic gastric cancer or gastroesophageal junction cancer.
The main questions it aims to answer are:
1、What is the objective response rate (ORR) of the combination of QL1706 and SOX chemotherapy? 2、What are the safety and tolerability of this combination therapy? Participants will：
1. Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 weeks. 2. Receive SOX chemotherapy (Oxaliplatin via intravenous infusion on Day 1 and S-1 orally twice daily for 14 days) every 3 weeks for up to 6 cycles. 3. Continue maintenance therapy with QL1706 combined with S-1 after 6 cycles until disease progression or unacceptable toxicity. 4. Undergo tumor imaging assessments (CT or MRI) every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter to monitor the disease.
Voluntarily participate in the clinical study; fully understand and are informed about the study and sign the Informed Consent Form (ICF); willing to follow and able to complete all trial procedures.
Age 18-80 years, gender is not limited.
Patients with locally advanced unresectable, recurrent unresectable, or metastatic gastric cancer (GC) or gastroesophageal junction cancer (GEJC) confirmed by imaging and other examinations, and histopathologically confirmed as adenocarcinoma.
Provide a report confirming HER2 overexpression or amplification negativity; defined as IHC 0/1+, or IHC 2+ with FISH/ISH negative.
White blood cell count (WBC) ≥ 3,000/mm³ (3.0 × 10⁹/L);
Absolute neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10⁹/L);
Platelet count (PLT) ≥ 100,000/mm³ (100 × 10⁹/L);
Hemoglobin (Hb) ≥ 9.0 g/dL (90 g/L).
Single group
Iparomlimab and Tuvonralimab (QL1706)
DrugAdministered via intravenous (IV) infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.
SOX Chemotherapy
DrugOxaliplatin: 130mg/m2, iv.gtt, single infusion, 21 days as a cycle, Day 1. Tigio: 40mg (body surface area(BSA)\<1.25m2), 50mg (BSA≥1.25m2, and BAS\<1.5m2), 60mg (BSA ≥1.5m2), p.o, bid, 21 days as a cycle, Day 1-14.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who achieve a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Disease Control Rate (DCR)
DCR is defined as the percentage of participants whose Best Overall Response (BOR) is confirmed as Complete Response (CR), Partial Response (PR), or Stable Disease (SD), as assessed by the investigator according to RECIST v1.1.
Progression-Free Survival (PFS)
PFS is defined as the time from the date of enrollment to the date of the first documented disease progression (according to RECIST v1.1) or death from any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from the date of enrollment to the date of death due to any cause.
1-Year Progression-Free Survival (PFS) Rate
The proportion of participants who are alive and free of disease progression at 1 year after enrollment.
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