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Clinical Trials in China / NCT06759233
Starting soon Phase 2

Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer

NCT06759233 · tracked via the Priya Life Science China tracker
Sponsor
Zhongguang Luo, MD
Phase
Phase 2
Started
2025-05-15
Last updated
2025-04-29

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

endoscopic cryoballoon ablation treatment(ECAT)+PD-1

endoscopic cryoballoon ablation treatment(ECAT)+PD-1: 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.

Study summary

To clarify the efficacy and safety of endoscopic cryoablation combined with PD-1 monoclonal antibody treatment regimen in advanced gastric cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Huashan Hospital, Fudan University Shanghai China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06759233 on ClinicalTrials.gov ↗ ← All trials in China