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
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.