Clinical trial NCT06957977: A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer
Official title: A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gastric Cancer
Cryoballoon Ablation
Keywords: Cryoballoon ablation
ECAT
PD-1
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: This study is a single-center, randomized, controlled, open-label, prospective clinical trial. A total of 42 patients with advanced gastric cancer will be enrolled. Among them, 30 patients who achieve a partial response (PR) after receiving standard of care (SOC) treatment - such as FOLFOX, POLF, FLOT, SOX, CAPOX, or FOLFIRI - will be randomly assigned to two groups. Twenty patients will receive local gastric endoscopic cryoballoon ablation treatment (ECAT) combined with sintilimab, while the remaining ten patients will receive sintilimab monotherapy. Both groups will subsequently undergo standard maintenance therapy, followed by assessments of treatment efficacy, safety, and immunological evaluations of both peripheral blood and tumor tissues. Patients whose disease status is assessed as stable disease (SD) or progressive disease (PD) after SOC treatment will proceed to receive standard second-line therapies.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From enrollment to study completion, assessed up to 2 years
measure: Overall-Survival (OS)
timeFrame: From enrollment to study completion, assessed up to 5 years
Secondary outcomes:
measure: Percentage of participants achieving complete remission (CR) and partial remission (PR) after treatment
timeFrame: 3 to 24 weeks after the end of treatment
measure: Percentage of participants achieving remission (PR+CR) and lesion stabilization (SD) after treatment
timeFrame: 3 to 24 weeks after the end of treatment
measure: Number of participants with treatment-related adverse events
timeFrame: From the start of treatment to 24 weeks after the end of treatment
Other outcomes:
measure: Number of immune cells in peripheral blood
timeFrame: From enrollment to study completion, assessed up to 24 weeks
measure: Number of immune cells in tumor tissues
timeFrame: From enrollment to study completion, assessed up to 24 weeks
Locations:
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University, Shanghai
state: Shanghai
Study officials:
References: