A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer

Korábbi kezelés

• Patients with other concurrent primary malignancies;
• Patients who have taken antiplatelet or anticoagulant medications within the past week;

Más betegség

• Patients with infectious diseases (such as HIV, syphilis, or active tuberculosis);
• Patients with active hepatitis B or hepatitis C infection;
• Patients with gastric cancer complicated by active bleeding;
• Patients with active infections or autoimmune diseases;

Egyéb

• Pregnant or breastfeeding women, or women planning to become pregnant within six months;
• Patients who have participated in another clinical trial within the past month;
• Patients with massive ascites (ascites volume ≥3000 mL);
• Patients with cardia obstruction or pyloric obstruction;
• Patients deemed unsuitable for treatment by the investigator for any other reason.

• Patients diagnosed with advanced gastric cancer (stage IV according to the AJCC 8th edition, including locally advanced unresectable gastric cancer [stage IVa] and gastric cancer with distant metastasis [stage IVb]; Borrmann classification types I, II, or III) who are deemed ineligible for surgical resection or unable to tolerate surgery, and meet the indications for first-line therapy with sintilimab combined with fluoropyrimidine- and platinum-based chemotherapy;
• Age ≥18 years;
• WHO pathological types: adenocarcinoma or neuroendocrine tumors;
• Physician-assessed estimated life expectancy greater than 3 months, with distant metastases considered controllable;
• Maximum diameter of the primary tumor ≤6 cm;
• Adequate major organ function, defined as:① Liver function: ALT and AST ≤ 2.5 times the positive range, total bilirubin ≤ 2.0mg/dL; ② Renal function: creatinine clearance ≥ 40mL/min calculated using the EPI formula;
• Hematological criteria: hemoglobin (Hgb) ≥70 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥80×10⁹/L;
• Coagulation function: prothrombin time (PT) and activated partial thromboplastin time (APTT) both <2 times the normal value;
• Negative pregnancy test for women of childbearing potential;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
• Signed informed consent form.