Clinical trial · Interventional
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
NCT06759233CI-TRIAL-00089014not yet recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To clarify the efficacy and safety of endoscopic cryoablation combined with PD-1 monoclonal antibody treatment regimen in advanced gastric cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic cryoballoon ablation treatment(ECAT)+PD-1 | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- endoscopic cryoballoon ablation treatment(ECAT)+ PD-1
- description
- Patients with advanced gastric cancer enrolled in the study will undergo ECAT (endoscopic cryoballoon ablation treatment). Within three days before or after ECAT treatment, they will receive the first dose of PD-1 monoclonal antibody therapy as part of this study (the dosing schedule for PD-1 therapy will follow the drug's prescribing information).
- interventionNames
- Procedure: endoscopic cryoballoon ablation treatment(ECAT)+PD-1
Primary outcomes (2)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From enrollment to study completion, assessed up to 2 years
- description
- 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.
- measure
- Overall-Survival (OS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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; 2. Age greater than 18 years and less than 80 years; 3. WHO pathology type: adenocarcinoma, neuroendocrine tumor; 4. Expected survival greater than 3 months and controllable distant metastases as judged by the physician; 5. 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; 6. Blood routine: Hgb≥70g/L,ANC≥1.5×109/L,PLT≥80×109/L; 7. Coagulation function: PT and APPT \<2 times the normal value; 8. Pregnancy test must be negative in women of childbearing age; 9. ECOG score ≤2; 10. Signed informed consent. Exclusion Criteria: 1. Pregnant or breastfeeding women, or women with pregnancy plans within six months; 2. Infectious diseases (e.g. AIDS, syphilis, active tuberculosis); 3. Patients with active hepatitis B or C infection; 4. Combination of other primary malignant tumors; 5. Patients who have participated in a clinical trial within one month; 6. Patients taking antiplatelet or anticoagulant drugs within the last week; 7. Patients with gastric cancer combined with active bleeding; 8. Large amount of ascites (ascites ≥3000ml); 9. Cardia obstruction or pyloric obstruction; 10. patients with combined active infection or autoimmune disease; 11. Those who the doctor thinks there are other reasons not to be included in the treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.