A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

May 1, 2026

Study Completion Date

May 1, 2027

Conditions
Gastric CancerCryoballoon Ablation
Interventions
PROCEDURE

Endoscopic Cryoballoon Ablation Treatment

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.

DRUG

PD1 Inhibitor

The first administration of the PD-1 monoclonal antibody is initiated when patients achieve a partial response (PR) following standard treatment. Subsequent administrations are given every three weeks according to the prescribing information.

Trial Locations (1)

200000

Huashan Hospital, Fudan University, Shanghai, Shanghai

All Listed Sponsors
lead

Zhongguang Luo, MD

OTHER