To clarify the efficacy and safety of endoscopic cryoablation combined with PD-1 monoclonal antibody treatment regimen in advanced gastric cancer.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Huashan Hospital, Fudan University
Shanghai, China
Progression-Free Survival (PFS)
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.
Time frame: From enrollment to study completion, assessed up to 2 years
Overall-Survival (OS)
The length of time from the start of treatment until death from any cause.
Time frame: From enrollment to study completion, assessed up to 5 years
Percentage of participants achieving complete remission (CR) and partial remission (PR) after treatment
Objective remission rate (ORR), the percentage of participants whose tumors shrink by a certain amount and remain there for a certain period of time, including complete remission (CR) and partial remission (PR). CR (Complete remission): Complete disappearance of the target lesion, with no new lesions produced, and lasting for more than 4 weeks. PR (Partial remission): the sum of the largest diameters of the target lesions is reduced by more than 30%, and lasts for more than 4 weeks.
Time frame: 3 to 24 weeks after the end of treatment
Percentage of participants achieving remission (PR+CR) and lesion stabilization (SD) after treatment
Disease control rate (DCR) is the percentage of participants who achieve remission (PR+CR) and stabilization of lesions (SD) after the treatment. Stable disease (SD) means that the sum of the largest diameters of the tumor lesions has not shrunk to PR, or has not enlarged to PD.
Time frame: 3 to 24 weeks after the end of treatment
Number of participants with treatment-related adverse events
The number of patients who experience ECAT-related adverse events (such as intraoperative bleeding, intraoperative perforation, postoperative bleeding, etc.)
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Time frame: From the start of treatment to 24 weeks after the end of treatment