Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites

• Status: Enrolling by invitation
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This projectis aim to evaluate the efficacy of immune checkpoint inhibitor (pembrolizumab or nivolumab) on the malignant ascites of patients with advanced gastric, pancreatic and biliary tract cancers.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: China Medical University Hospital
• Treatments: Nivolumab; Pembrolizumab

Criteria

Inclusion Criteria:

• Patients have cyto-/histologically confirmed malignant ascites from gastric, pancreatic or biliary tract adenocarcinoma

• Patients have malignant ascites more than 1000ml

• Patients have no history of prior intraperitoneal therapy for malignant ascites

• Patients have life expectancy of at least 4 weeks

• Patients have adequate platelet count ≥ 50,000/ul

• Women or men of reproductive potential should agree to use an effective contraceptive method

• All patients must be informed of the investigational nature of this study and must sign written informed consents.

Exclusion Criteria:

• Patients have ascites which is related to causes other than the malignancies

• Patients who are receiving intraperitoneal treatment for their malignant ascites including therapeutic paracentesis

• Patients with active infection

• Patients with bleeding disorders

• Patient with active cardiopulmonary disease or history of ischemic heart disease

• Patients have intolerant abdominal pain

• Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator