Clinical trial · Interventional
Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites
The Effect of Intraperitoneal Immune Checkpoint Inhibitor on Malignant Ascites of Patients With Gastric, Pancreatic or Biliary Tract Cancer
NCT05745233CI-TRIAL-00069056enrolling by invitationN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Ascites | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nivolumab | Drug | Nivolumab | ALIAS |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Checkpoint inhibitor (nivolumab or pembrolizumab)
- description
- Patients with malignant ascites will received either nivolumab or pembrolizumab intraperitoneally.
- interventionNames
- Drug: Nivolumab
- Drug: Pembrolizumab
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- From the date of registration until the end of treatment, up to 2 years.
- description
- Control of ascites Rate of ascites control = number of patients who have less ascites determinded by five-point method and subjective symptoms / all patients
Secondary outcomes (1)
- measure
- Adverse effects
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDWang 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
- DERIVEDWang 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. 2026 Feb;31(2):281-291. doi: 10.1007/s10147-025-02930-y. Epub 2025 Dec 10. PMID 41369826