Status:
NOT_YET_RECRUITING
A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer
Lead Sponsor:
Zhongguang Luo, MD
Conditions:
Gastric Cancer
Cryoballoon Ablation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study evaluates the safety and efficacy of endoscopic cryoballoon ablation treatment (ECAT) combined with a PD-1 inhibitor (sintilimab) as maintenance therapy in patients with advanced gastric ca...
Detailed Description
This study is a single-center, randomized, controlled, open-label, prospective clinical trial. A total of 42 patients with advanced gastric cancer will be enrolled. Among them, 30 patients who achieve...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Pregnant or breastfeeding women, or women planning to become pregnant within six months;
- Patients with infectious diseases (such as HIV, syphilis, or active tuberculosis);
- Patients with active hepatitis B or hepatitis C infection;
- Patients with other concurrent primary malignancies;
- Patients who have participated in another clinical trial within the past month;
- Patients who have taken antiplatelet or anticoagulant medications within the past week;
- Patients with gastric cancer complicated by active bleeding;
- Patients with massive ascites (ascites volume ≥3000 mL);
- Patients with cardia obstruction or pyloric obstruction;
- Patients with active infections or autoimmune diseases;
- Patients deemed unsuitable for treatment by the investigator for any other reason.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06957977
Start Date
May 1 2025
End Date
May 1 2027
Last Update
May 6 2025
Active Locations (1)
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1
Huashan Hospital, Fudan University, Shanghai
Shanghai, Shanghai Municipality, China, 200000