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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| endoscopic cryoballoon ablation treatment(ECAT)+ PD-1 | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| endoscopic cryoballoon ablation treatment(ECAT)+PD-1 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | From enrollment to study completion, assessed up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of immune cells in peripheral blood | Peripheral blood will be analyzed for the number of immune cells after applying flow cytometry and mRNA sequencing. | From enrollment to study completion, assessed up to 24 weeks |
| Number of immune cells in tumor tissues |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Shanghai | China |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 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. | 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.) | From the start of treatment to 24 weeks after the end of treatment |
Apply mRNA sequencing, immunohistochemistry and immunofluorescence to analyze the number of immune cells in tumor tissues, including CTL, Treg, DC, TAM, MDSC, NK, NKT and so on. |
| From enrollment to study completion, assessed up to 24 weeks |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |