NCT06957977Not yet recruitingPhase 2
A Randomized Controlled Study of Endoscopic Cryoablation Combined With PD-1 Inhibitor for Maintenance Therapy in Advanced Gastric Cancer
Source: ClinicalTrials.gov · Last updated 6 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 27 Apr 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 May 2026
- Lead sponsor
- Zhongguang Luo, MD
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06957977
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 1 May 2025 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with other concurrent primary malignancies;
- Patients who have taken antiplatelet or anticoagulant medications within the past week;
Other illness
- Patients with infectious diseases (such as HIV, syphilis, or active tuberculosis);
- Patients with active hepatitis B or hepatitis C infection;
- Patients with gastric cancer complicated by active bleeding;
- Patients with active infections or autoimmune diseases;
Other
- Pregnant or breastfeeding women, or women planning to become pregnant within six months;
- Patients who have participated in another clinical trial within the past month;
- Patients with massive ascites (ascites volume ≥3000 mL);
- Patients with cardia obstruction or pyloric obstruction;
- Patients deemed unsuitable for treatment by the investigator for any other reason.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University, Shanghai Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.