This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma
Aged 18-75 years, gender is not limited;
Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
HER2-negative by immunohistochemistry (IHC);
low PD-L1 expression status (CPS < 5);
Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
Cardiovascular and cerebrovascular events that are not well controlled;
Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks;
Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
Single group
Iparomlimab and Tuvonralimab (QL1706)
Drug5 mg/kg, ivdrip, Day 1, Q3W, until progressive disease or intolerable toxicity.
Oxallplation
Drug130 mg/m2, ivdrip, Day 1, Q3W, for the first 6 cycles.
Capectitabine Tablets
Drug1000 mg/m2, po, bid, Days 1-14, Q3W, until progressive disease or intolerable toxicity.
progression-free survival (PFS)
The time from the starting date of study drug to the date of first documentation of disease progression or death, whichever occurs first (per RECIST 1.1).
overall survival (OS)
The time from the starting date of study drug to the date of death due to any cause.
objective response rate (ORR)
The proportion of subjects with complete response (CR) and partial response (PR) according RESIST1.1 in total subjects.
duration of response (DOR)
The time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first.
disease control rate (DCR)
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD) in total subjects
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