Gastric and Gastroesophageal Junction Adenocarcinoma
Conditions
Interventions
Treatment group:Iparomlimab and Tuvonralimab Injection+Oxaliplatin +Capecitabine
Sponsors
Qilu Hospital of Shandong University (Qingdao)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 and =90 g/L, neutrophil count >=1.5×10^9/L, platelet count >=80×10^9/L, serum albumin >=30 g/L. Hepatic Function: Total bilirubin 2000 copies/mL, oral antiviral therapy must be initiated >=1 week before study enrollment. 9.Male participants of reproductive potential must agree to use adequate contraception for 120 days after the last treatment. Female participants of reproductive potential must be willing to use adequate contraception during the study and until 120 days after the last treatment. 10.Life expectancy greater than 6 months. 11.The subject voluntarily participates in this study, has signed the informed consent form, demonstrates good compliance, and cooperates with follow-up visits.
Exclusion criteria
Exclusion criteria: 1.Patients with adenosquamous carcinoma, squamous cell carcinoma, or gastrointestinal stromal tumor (GIST); 2.Patients with peritoneal dissemination or distant metastasis; 3.Patients who have received prior antitumor therapy or radiotherapy for any malignancy; 4.Allergy to any investigational drug or its excipients, history of severe hypersensitivity, or contraindications to the investigational drug; 5.Patients with poorly controlled cardiovascular/cerebrovascular events, including: NYHA Class II+ heart failure Unstable angina Myocardial infarction within 1 year Clinically significant supraventricular/ventricular arrhythmias requiring treatment Cerebral hemorrhage or infarction (excluding asymptomatic lacunar infarcts not needing therapy) Major cardiovascular events within 12 months Uncontrolled hypertension (SBP >140mmHg or DBP >90mmHg despite monotherapy) Arterial/venous thrombosis within 6 months, or bleeding tendency within 2 months (regardless of severity) Stroke or transient ischemic attack (TIA) within 12 months; 6.Systemic therapy with traditional Chinese medicines (TCM) approved for gastric cancer or immunomodulators (e.g., thymosin, interferon, interleukin) within 2 weeks prior to the first dose, except for localized use to manage ascites; 7.Patients with a history of interstitial lung disease (ILD), non-infectious pneumonia, pulmonary fibrosis, acute lung diseases, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension, etc.); 8.Patients with active immunodeficiency or a history of autoimmune diseases, including: HIV-positive status Other acquired/congenital immunodeficiency disorders Organ transplant history Autoimmune diseases (e.g., rheumatoid arthritis, lupus); 9.Patients with severe chronic or active infections requiring systemic antibacterial, antifungal, or antiviral therapy (including tuberculosis) must be excluded. Those with a history of active TB infection within >=1 year prior to screening are also excluded, unless documented proof of completed appropriate treatment is provided. Known histories of hepatitis B or hepatitis C virus infection are additional exclusion criteria. 10.Patients with a clinically detectable second primary malignancy at enrollment, or a history of other malignancies within the past 5 years (except adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix), are excluded; 11.Any major surgical procedures performed <=28 days prior to the first dose of the investigational drug; 12.Patients with a history of allogeneic stem cell transplantation or solid organ transplantation; 13.Patients with current gastrointestinal disorders (e.g., duodenal ulcer, ulcerative colitis, intestinal obstruction) or other conditions deemed by investigators to pose risks of gastrointestinal bleeding/perforation; or a history of intestinal perforation/fistula with incomplete recovery post-surgery; 14.Patients who have received live vaccines within 30 days prior to the first dose of the investigational treatment; 15.Subjects deemed by the investigator to have other factors that may lead to premature study termination, including: Comorbid severe diseases (e.g., uncontrolled psychiatric/mental disorders requiring concurrent therapy); Clinically significant laboratory abnormalities; Social/family circumstances compromising subject safety or data/sample collection; 16.Currently participating in interventional clinical trials or having received other invest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Disease-free survival;R0 resection rate;2-year overall survival rate (2-year OS rate);Safety; | — |
Countries
China
Contacts
Public ContactCao Fangli
Qilu Hospital of Shandong University (Qingdao)
Outcome results
None listed