Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer

Официальное название

Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer and Its Immune Activation Mechanism Study

Обзор

To clarify the efficacy and safety of endoscopic cryoablation combined with PD-1 monoclonal antibody treatment regimen in advanced gastric cancer.

Подробное описание

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.

Вмешательства

• Процедура endoscopic cryoballoon ablation treatment(ECAT)+PD-1
  ECAT: A cryoballoon with catheter is inserted along the endoscopic forceps channel, the balloon is placed on the surface of the tumor, and the balloon is dilated so that it fits snugly over the lesion. The freezing cycle is initiated and continued for 2-3 minutes, and then the balloon is rewarmed and frozen again for 2-3 minutes; the freeze-rewarm cycle is repeated twice. PD-1:The first PD-1 monoclonal antibody treatment in this study was given within 3 days before and after ECAT treatment, and

Первичные конечные точки

• Progression-Free Survival (PFS) [Срок оценки: From enrollment to study completion, assessed up to 2 years]
• Overall-Survival (OS) [Срок оценки: From enrollment to study completion, assessed up to 5 years]

Вторичные конечные точки (3)

• Percentage of participants achieving complete remission (CR) and partial remission (PR) after treatment [Срок оценки: 3 to 24 weeks after the end of treatment]
• Percentage of participants achieving remission (PR+CR) and lesion stabilization (SD) after treatment [Срок оценки: 3 to 24 weeks after the end of treatment]
• Number of participants with treatment-related adverse events [Срок оценки: From the start of treatment to 24 weeks after the end of treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Huashan Hospital, Fudan University — Шанхай

Идентификаторы

NCT: NCT06759233 · KY2024-1042

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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