Clinical trial NCT06759233: Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer
Official title: Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer and Its Immune Activation Mechanism Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: ECAT
PD-1
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Age greater than 18 years and less than 80 years;
3. WHO pathology type: adenocarcinoma, neuroendocrine tumor;
4. Expected survival greater than 3 months and controllable distant metastases as judged by the physician;
5. 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;
6. Blood routine: Hgb≥70g/L,ANC≥1.5×109/L,PLT≥80×109/L;
7. Coagulation function: PT and APPT \<2 times the normal value;
8. Pregnancy test must be negative in women of childbearing age;
9. ECOG score ≤2;
10. Signed informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or women with pregnancy plans within six months;
2. Infectious diseases (e.g. AIDS, syphilis, active tuberculosis);
3. Patients with active hepatitis B or C infection;
4. Combination of other primary malignant tumors;
5. Patients who have participated in a clinical trial within one month;
6. Patients taking antiplatelet or anticoagulant drugs within the last week;
7. Patients with gastric cancer combined with active bleeding;
8. Large amount of ascites (ascites ≥3000ml);
9. Cardia obstruction or pyloric obstruction;
10. patients with combined active infection or autoimmune disease;
11. Those who the doctor thinks there are other reasons not to be included in the treatment.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From enrollment to study completion, assessed up to 2 years
measure: Overall-Survival (OS)
timeFrame: From enrollment to study completion, assessed up to 5 years
Secondary outcomes:
measure: Percentage of participants achieving complete remission (CR) and partial remission (PR) after treatment
timeFrame: 3 to 24 weeks after the end of treatment
measure: Percentage of participants achieving remission (PR+CR) and lesion stabilization (SD) after treatment
timeFrame: 3 to 24 weeks after the end of treatment
measure: Number of participants with treatment-related adverse events
timeFrame: From the start of treatment to 24 weeks after the end of treatment
Other outcomes:
measure: Number of immune cells in peripheral blood
timeFrame: From enrollment to study completion, assessed up to 24 weeks
measure: Number of immune cells in tumor tissues
timeFrame: From enrollment to study completion, assessed up to 24 weeks
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
Study officials:
References: