NCT06759233Not yet recruitingPhase 2
Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer
Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer and Its Immune Activation Mechanism Study
Source: ClinicalTrials.gov · Last updated 29 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To clarify the efficacy and safety of endoscopic cryoablation combined with PD-1 monoclonal antibody treatment regimen in advanced gastric cancer.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 19 Sept 2024
- Start date
- 15 May 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Zhongguang Luo, MD
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06759233
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 15
- From 15 May 2025 to the primary completion date, 31 Dec 2025
- 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 taking antiplatelet or anticoagulant drugs within the last week;
Other illness
- Infectious diseases (e.g. AIDS, syphilis, active tuberculosis);
- Patients with active hepatitis B or C infection;
- Combination of other primary malignant tumors;
- Patients with gastric cancer combined with active bleeding;
- patients with combined active infection or autoimmune disease;
Other
- Pregnant or breastfeeding women, or women with pregnancy plans within six months;
- Patients who have participated in a clinical trial within one month;
- Large amount of ascites (ascites ≥3000ml);
- Cardia obstruction or pyloric obstruction;
- Those who the doctor thinks there are other reasons not to be included in the treatment.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.