Overview
Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2026-12-01
2026-12-01
Target enrollment:
0
0
Participant gender:
All
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/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
China Medical University HospitalTreatments:
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