Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer and Its Immune Activation Mechanism Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
To clarify the efficacy and safety of endoscopic cryoablation combined with PD-1 monoclonal antibody treatment regimen in advanced gastric cancer.
详细描述
This study is a single-center, single-arm, self-controlled, experimental, non-randomized exploratory clinical trial, aiming to enroll 15 patients with advanced gastric cancer. Each enrolled patient will be assigned a case number. This case number, along with the patient's name initials, will be recorded on every page of the case report form (CRF). Enrolled patients will receive local gastric ECAT (endoscopic cryoballoon ablation treatment) combined with PD-1 monoclonal antibody therapy for the evaluation of efficacy and safety, as well as immunological assessments of peripheral circulation and local tumor tissue. Patients will be followed during the treatment period and for six months after treatment termination for study observation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（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 in AJCC 8th edition staging, including locally progressive gastric cancer with unresectable factors (IVa) and gastric cancer with distant metastases (IVb); Bowman's staging type I, II, and III), who are unable to be surgically resected or do not tolerate surgical resection, and who have undergone progression after 1-2 lines of conventional chemotherapy;
- •Age greater than 18 years and less than 80 years;
- •WHO pathology type: adenocarcinoma, neuroendocrine tumor;
- •Expected survival greater than 3 months and controllable distant metastases as judged by the physician;
- •Important organ functions must be met: 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;
- •Blood routine: Hgb≥70g/L,ANC≥1.5×109/L,PLT≥80×109/L;
- •Coagulation function: PT and APPT <2 times the normal value;
- •Pregnancy test must be negative in women of childbearing age;
- •ECOG score ≤2;
- •Signed informed consent.
排除标准
- •Pregnant or breastfeeding women, or women with pregnancy plans within six months;
- •Infectious diseases (e.g. AIDS, syphilis, active tuberculosis);
- •Patients with active hepatitis B or C infection;
- •Combination of other primary malignant tumors;
- •Patients who have participated in a clinical trial within one month;
- •Patients taking antiplatelet or anticoagulant drugs within the last week;
- •Patients with gastric cancer combined with active bleeding;
- •Large amount of ascites (ascites ≥3000ml);
- •Cardia obstruction or pyloric obstruction;
- •patients with combined active infection or autoimmune disease;
- •Those who the doctor thinks there are other reasons not to be included in the treatment.
研究组 & 干预措施
endoscopic cryoballoon ablation treatment（ECAT）+ PD-1
Patients with advanced gastric cancer enrolled in the study will undergo ECAT (endoscopic cryoballoon ablation treatment). Within three days before or after ECAT treatment, they will receive the first dose of PD-1 monoclonal antibody therapy as part of this study (the dosing schedule for PD-1 therapy will follow the drug's prescribing information).
干预措施: endoscopic cryoballoon ablation treatment(ECAT)+PD-1 (Procedure)
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