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NCT06957977

PHASE2

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

Sponsor: Zhongguang Luo, MD

View on ClinicalTrials.gov

Summary

This study evaluates the safety and efficacy of endoscopic cryoballoon ablation treatment (ECAT) combined with a PD-1 inhibitor (sintilimab) as maintenance therapy in patients with advanced gastric cancer, and further explores the underlying immunoregulatory mechanisms.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-01

Completion Date

2027-05-01

Last Updated

2025-05-06

Healthy Volunteers

Conditions

Gastric Cancer Cryoballoon 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.

Inclusion Criteria: 1. Patients diagnosed with advanced gastric cancer (stage IV according to the AJCC 8th edition, including locally advanced unresectable gastric cancer \[stage IVa\] and gastric cancer with distant metastasis \[stage IVb\]; Borrmann classification types I, II, or III) who are deemed ineligible for surgical resection or unable to tolerate surgery, and meet the indications for first-line therapy with sintilimab combined with fluoropyrimidine- and platinum-based chemotherapy; 2. Age ≥18 years; 3. WHO pathological types: adenocarcinoma or neuroendocrine tumors; 4. Physician-assessed estimated life expectancy greater than 3 months, with distant metastases considered controllable; 5. Maximum diameter of the primary tumor ≤6 cm; 6. Adequate major organ function, defined as: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; 7. Hematological criteria: hemoglobin (Hgb) ≥70 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥80×10⁹/L; 8. Coagulation function: prothrombin time (PT) and activated partial thromboplastin time (APTT) both \<2 times the normal value; 9. Negative pregnancy test for women of childbearing potential; 10. Eastern Cooperative Oncology Group (ECOG) performance status ≤2; 11. Signed informed consent form. Exclusion Criteria: 1. Pregnant or breastfeeding women, or women planning to become pregnant within six months; 2. Patients with infectious diseases (such as HIV, syphilis, or active tuberculosis); 3. Patients with active hepatitis B or hepatitis C infection; 4. Patients with other concurrent primary malignancies; 5. Patients who have participated in another clinical trial within the past month; 6. Patients who have taken antiplatelet or anticoagulant medications within the past week; 7. Patients with gastric cancer complicated by active bleeding; 8. Patients with massive ascites (ascites volume ≥3000 mL); 9. Patients with cardia obstruction or pyloric obstruction; 10. Patients with active infections or autoimmune diseases; 11. Patients deemed unsuitable for treatment by the investigator for any other reason.

Locations (1)

Huashan Hospital, Fudan University, Shanghai

Shanghai, Shanghai Municipality, China