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NCT05745233Enrolling by invitation

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

Source: ClinicalTrials.gov · Last updated 24 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Interventional
Enrollment
30 (estimated)
First submitted
16 Feb 2023
Start date
1 Jan 2021
Primary completion date
Dec 2026
Lead sponsor
China Medical University Hospital
NCT number
NCT05745233

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 1 Jan 2021 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Patients have intolerant abdominal pain

Who the study is looking for

  • 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.

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
China Medical University Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.