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Clinical Trials in China / NCT05745233
Enrolling by invitation Not applicable

Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites

NCT05745233 · tracked via the Priya Life Science China tracker
Sponsor
China Medical University Hospital
Phase
Not applicable
Started
2021-01-01
Last updated
2023-08-24

Condition(s) studied

Malignant Ascites

Investigational drug(s) / intervention(s)

Nivolumab →Pembrolizumab →

Nivolumab: 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: 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 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Response rate — From the date of registration until the end of treatment, up to 2 years.
    Control of ascites Rate of ascites control = number of patients who have less ascites determinded by five-point method and subjective symptoms / all patients

Trial sites (1)

FacilityCityRegionStatus
China Medical University Hospital Taichung Please Select

On this site

📄 Opdivo (nivolumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile →

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Other trials for the same condition

Treatment of Malignant Ascites Caused by Advanced Epithelial Solid Tumors With M701 Bispecific Antibody Active, not recruiting
Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy Recruiting
Dual-targeting VEGFR1 and PD-L1 CAR-T for Pleural, Peritoneal, or Leptomeningeal Metastases Recruiting
A Phase I Study of SIM0388 in Participants With Malignant Ascites. Recruiting
WSK-IM02 in Advanced Solid Tumors With Malignant Effusions (Phase I) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05745233 on ClinicalTrials.gov ↗ ← All trials in China