Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites

Sponsor
China Medical University Hospital
Study ID
NCT05745233
Status
Enrolling By Invitation

Conditions

  • Malignant Ascites

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 1, 2021
Status verified
Aug 2023
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Checkpoint inhibitor (nivolumab or pembrolizumab)
    Patients with malignant ascites will received either nivolumab or pembrolizumab intraperitoneally.

Primary Outcome Measure

Response rate [ Time Frame: From the date of registration until the end of treatment, up to 2 years. ]

Related Studies