A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
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 cancer, and further explores the underlying immunoregulatory mechanisms.
详细描述
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 a partial response (PR) after receiving standard of care (SOC) treatment - such as FOLFOX, POLF, FLOT, SOX, CAPOX, or FOLFIRI - will be randomly assigned to two groups. Twenty patients will receive local gastric endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab, while the remaining ten patients will receive sintilimab monotherapy. Both groups will subsequently undergo standard maintenance therapy, followed by assessments of treatment efficacy, safety, and immunological evaluations of both peripheral blood and tumor tissues. Patients whose disease status is assessed as stable disease (SD) or progressive disease (PD) after SOC treatment will proceed to receive standard second-line therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
ECAT + PD-1
Patients who achieve a partial response (PR) following standard treatment will subsequently receive gastric local endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab. Sintilimab will be administered within three days before and after the ECAT procedure, and continued regularly thereafter.
干预措施: Endoscopic Cryoballoon Ablation Treatment (Procedure)
ECAT + PD-1
Patients who achieve a partial response (PR) following standard treatment will subsequently receive gastric local endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab. Sintilimab will be administered within three days before and after the ECAT procedure, and continued regularly thereafter.
干预措施: PD1 Inhibitor (Drug)
PD-1
The remaining 10 patients who achieve a partial response (PR) following standard treatment will receive sintilimab monotherapy, followed by standard maintenance therapy.
干预措施: PD1 Inhibitor (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From enrollment to study completion, assessed up to 2 years
PFS is measured from the start of treatment until the first documented evidence of disease progression (based on RECIST 1.1) or death from any cause, whichever occurs first.
Overall-Survival (OS)
时间窗: From enrollment to study completion, assessed up to 5 years
The length of time from the start of treatment until death from any cause.
次要结局
- Percentage of participants achieving complete remission (CR) and partial remission (PR) after treatment(3 to 24 weeks after the end of treatment)
- Percentage of participants achieving remission (PR+CR) and lesion stabilization (SD) after treatment(3 to 24 weeks after the end of treatment)
- Number of participants with treatment-related adverse events(From the start of treatment to 24 weeks after the end of treatment)
研究者
Zhongguang Luo, MD
Chief Physician
Huashan Hospital