Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma

Prior treatment

• 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;
• Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;
• Any major surgery was performed ≤ 28 days before the first trial drug administration;
• Live vaccine was inoculated within 4 weeks (inclusive) before the first administration of the trial drug, not including seasonal influenza vaccines but intranasal vaccine.
• Participating in other therapeutic clinical studies or using research instruments within 4 weeks before the first administration;

Other illness

• Allergic to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
• 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.);
• Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;
• Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;
• Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);
• History of allogeneic stem cell transplantation or organ transplantation;
• Duodenal ulcer, ulcerative colitis, intestinal obstruction and other gastrointestinal diseases at present; or other conditions that may cause gastrointestinal bleeding or perforation judged by the researchers; or history of intestinal perforation or fistula, but has not recovered after surgical treatment;
• Others conditions do not meet the inclusion according to the judgment of the investigator.

Lab values

• Has other factors that may lead to the forced termination of this trial according to the judgment of the investigator, such as other serious diseases (including psychological and mental diseases) requiring combined treatment, serious laboratory examination abnormalities, and family or social factors, which may affect the safety of the subject, or the collection of data and samples;

Other

• Cardiovascular and cerebrovascular events that are not well controlled;
• Brain metastasis or leptomeningeal metastasis;

• 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);
• Has at least 1 measurable lesion as determined by RECIST 1.1;
• No systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Adequate organ function;
• The life expectancy is at least 3 months;
• Willing to join the study and signed an informed consent form (ICF) with good compliance and cooperation in follow-up.