Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer

NCT06759233 | Not Yet Recruiting Phase 2

• 1 other identifier: KY2024-1042
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastric Cancer

Keywords

ECAT; PD-1

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Percentage of participants achieving complete remission (CR) and partial remission (PR) after treatment

  3 to 24 weeks after the end of treatment

• Percentage of participants achieving remission (PR+CR) and lesion stabilization (SD) after treatment

  3 to 24 weeks after the end of treatment

• Number of participants with treatment-related adverse events

  From the start of treatment to 24 weeks after the end of treatment

Other Outcomes (2)

• Number of immune cells in peripheral blood

  From enrollment to study completion, assessed up to 24 weeks

• Number of immune cells in tumor tissues

  From enrollment to study completion, assessed up to 24 weeks

Study Arms (1)

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).

Procedure: endoscopic cryoballoon ablation treatment(ECAT)+PD-1

Interventions

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.

endoscopic cryoballoon ablation treatment（ECAT）+ PD-1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Zhongguang Luo, MD: lead

Study Sites (1)

Huashan Hospital, Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: January 6, 2025
• Study Start: May 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

CN (1)