Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites

NCT05745233 | Enrolling By Invitation

• 1 other identifier: CMUH107-REC1-180
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Ascites

Outcome Measures

Primary Outcomes (1)

• Response rate

  Control of ascites Rate of ascites control = number of patients who have less ascites determinded by five-point method and subjective symptoms / all patients

  From the date of registration until the end of treatment, up to 2 years.

Secondary Outcomes (1)

• Adverse effects

  From the date of registration until treatment termination, up to 2 years.

Study Arms (1)

Checkpoint inhibitor (nivolumab or pembrolizumab)

EXPERIMENTAL

Patients with malignant ascites will received either nivolumab or pembrolizumab intraperitoneally.

Drug: Nivolumab; Drug: Pembrolizumab

Interventions

Nivolumab DRUG

Intraperitoneal administration of nivolumab Nivolumab 20 mg in normal saline 100ml will be infused intraperitoneally through a temporary catheter in 10 minutes after paracentesis in a weekly interval.

Also known as: Opdivo

Checkpoint inhibitor (nivolumab or pembrolizumab)

Pembrolizumab DRUG

Intraperitoneal administration of pembrolizumab Pembrolizumab 20 mg in normal saline 100ml will be infused intraperitoneally through a temporary catheter in 10 minutes after paracentesis in a weekly interval.

Also known as: Keytruda

Checkpoint inhibitor (nivolumab or pembrolizumab)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Please Select, 404, Taiwan

Location

Related Publications (2)

• Wang ST, Chiu CF, Bai HJ, Bai LY. Intraperitoneal nivolumab in a patient with pancreatic cancer and refractory malignant ascites. Eur J Cancer. 2021 May;148:48-50. doi: 10.1016/j.ejca.2021.01.045. Epub 2021 Mar 15. No abstract available.

  PMID: 33735808 BACKGROUND

• Wang HT, Yu YL, Lo WJ, Lin MC, Chu CL, Chen CY, Wang ST, Chiu CF, Bai EJ, Bai LY. Intraperitoneal nivolumab for malignant ascites in patients with advanced gastrointestinal or pancreaticobiliary tract cancer. Int J Clin Oncol. 2025 Dec 10. doi: 10.1007/s10147-025-02930-y. Online ahead of print.

  PMID: 41369826 DERIVED

MeSH Terms

Interventions

Nivolumab; pembrolizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Li-Yuan Bai

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Division of Hematology and Oncology

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: February 27, 2023
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)