Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer

NCT ID: NCT06759233

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-15
• Study Completion Date: 2026-12-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

endoscopic cryoballoon ablation treatment(ECAT)+PD-1

Intervention Type: PROCEDURE

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 subsequent treatment was given every three weeks according to the instructions.

Interventions

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 subsequent treatment was given every three weeks according to the instructions.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongguang Luo, MD

OTHER

Sponsor Role: lead

Responsible Party

Zhongguang Luo, MD

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Huashan Hospital, Fudan University

Shanghai, , China

Countries

China

Facility Contacts

Wanwei Zheng

Role: primary

calebzww@yeah.net

+86 13816431448

Other Identifiers

KY2024-1042

Identifier Type: -

Identifier Source: org_study_id