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

NCT06957977 | Not Yet Recruiting Phase 2

• 1 other identifier: KY2025-081
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gastric Cancer; Cryoballoon Ablation

Keywords

Cryoballoon ablation; 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 (2)

ECAT + PD-1

EXPERIMENTAL

Patients who achieve a partial response (PR) following standard treatment will subsequently receive gastric local endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab. Sintilimab will be administered within three days before and after the ECAT procedure, and continued regularly thereafter.

Procedure: Endoscopic Cryoballoon Ablation Treatment; Drug: PD1 Inhibitor

PD-1

ACTIVE COMPARATOR

The remaining 10 patients who achieve a partial response (PR) following standard treatment will receive sintilimab monotherapy, followed by standard maintenance therapy.

Drug: PD1 Inhibitor

Interventions

Endoscopic Cryoballoon Ablation Treatment 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.

Also known as: ECAT

ECAT + PD-1

PD1 Inhibitor DRUG

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.

ECAT + PD-1; PD-1

Eligibility Criteria

• Age: 18 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 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;
• Age ≥18 years;
• WHO pathological types: adenocarcinoma or neuroendocrine tumors;
• Physician-assessed estimated life expectancy greater than 3 months, with distant metastases considered controllable;
• Maximum diameter of the primary tumor ≤6 cm;
• 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;
• Hematological criteria: hemoglobin (Hgb) ≥70 g/L; absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥80×10⁹/L;
• Coagulation function: prothrombin time (PT) and activated partial thromboplastin time (APTT) both \<2 times the normal value;
• Negative pregnancy test for women of childbearing potential;
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2;
• Signed informed consent form.

You may not qualify if:

• Pregnant or breastfeeding women, or women planning to become pregnant within six months;
• Patients with infectious diseases (such as HIV, syphilis, or active tuberculosis);
• Patients with active hepatitis B or hepatitis C infection;
• Patients with other concurrent primary malignancies;
• Patients who have participated in another clinical trial within the past month;
• Patients who have taken antiplatelet or anticoagulant medications within the past week;
• Patients with gastric cancer complicated by active bleeding;
• Patients with massive ascites (ascites volume ≥3000 mL);
• Patients with cardia obstruction or pyloric obstruction;
• Patients with active infections or autoimmune diseases;
• Patients deemed unsuitable for treatment by the investigator for any other reason.

Sponsors & Collaborators

• Zhongguang Luo, MD: lead

Study Sites (1)

Huashan Hospital, Fudan University, Shanghai

Shanghai, Shanghai Municipality, 200000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

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

Model Details: Patients will first receive standard treatment regimens (such as FOLFOX, POLF, FLOT, SOX, CAPOX, or FOLFIRI). Among these, 30 patients with advanced gastric cancer who achieve a partial response (PR) following standard treatment will undergo peripheral blood and local tumor tissue immunological evaluations, and will then be randomly assigned into two groups. Twenty patients will receive gastric local endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab, while ten patients will receive sintilimab monotherapy. Subsequently, both groups will continue with standard maintenance therapy, followed by assessments of treatment efficacy and safety.

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 6, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-04

Locations

CN (1)