Tests nivolumab or pembrolizumab in the belly for fluid from advanced cancers
Tests immune drugs given into the abdomen for fluid buildup from cancer.
Plain-language title generated from the registry record
Registry title: Intraperitoneal Immune Checkpoint Inhibitor for Malignant Ascites
Key facts
- Where
- Taichung, TaiwanSee the site
Where in Taiwan
- China Medical University HospitalTaichung, TaiwanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China Medical University Hospital
- Trial code
- NCT05745233
- Record updated
- 24 August 2023
- Original description
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.Read full original descriptionShow less
The Effect of Intraperitoneal Immune Checkpoint Inhibitor on Malignant Ascites of Patients With Gastric, Pancreatic or Biliary Tract Cancer
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.
Inclusion: 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: Patients who are receiving intraperitoneal treatment for their malignant ascites including therapeutic paracentesis; 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; Patients have ascites which is related to causes other than the malignancies; Patients with active infection; Patients with bleeding disorders; Patient with active cardiopulmonary disease or history of ischemic heart disease; Patients have intolerant abdominal pain.