Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06438822

Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma

Led by West China Hospital · Updated on 2025-05-07

51

Participants Needed

1

Research Sites

117 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aimed to evaluate the efficacy and safety of the combination of cadonilimab with liposomal irinotecan plus fluorouracil and leucovorin for the treatment of advanced biliary tract cancer.

CONDITIONS

Official Title

Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with pathologically confirmed locally advanced unresectable or metastatic adenocarcinoma of the bile ducts, gallbladder, or cholangiocellular carcinoma, with primary tumors located in the intrahepatic bile ducts, hilar bile ducts, distal bile ducts, or gallbladder
  • Progression after prior gemcitabine-based systemic chemotherapy and refusal or intolerance to initial gemcitabine-based chemotherapy regimens
  • At least one measurable objective tumor lesion according to RECIST version 1.1 criteria with a maximum diameter 1 cm for spiral CT or 2 cm for plain CT or MRI performed within 28 days before enrollment
  • Aged 18 to 75 years old
  • Eastern Cooperative Oncology Group performance status (ECOG PS)  1
  • Life expectancy greater than 3 months
  • Able to participate voluntarily and sign informed consent
  • Adequate organ and bone marrow function: absolute neutrophil count 1.510^9/L, platelet count 7510^9/L, hemoglobin 90 g/L; alanine aminotransferase and aspartate aminotransferase 2.5 times the upper limit of normal; total bilirubin and serum creatinine 1.5 times the upper limit of normal
Not Eligible

You will not qualify if you...

  • Disease-free survival within 5 years due to other malignancies (except treated basal cell carcinoma of the skin and carcinoma in situ of the cervix)
  • Serious or uncontrolled infectious diseases (HIV, HBV DNA  500 IU/ml)
  • Severe uncontrolled acute infections causing fever of 38 C or higher
  • Severe hepatic or renal insufficiency or recent myocardial infarction within 3 months
  • Current or past autoimmune disease or susceptibility to recurrence
  • Serious or uncontrolled pleural effusion or ascites
  • Active tuberculosis infection within 1 year before study drug administration; history of chronic diarrhea or complete intestinal obstruction
  • Need for systemic corticosteroids (>10 mg/day prednisone equivalent) or other immunosuppressives within 14 days before study drug
  • Other serious medical or surgical conditions affecting organ function
  • Participation in another clinical trial within 4 weeks
  • Pregnant or breastfeeding women or individuals of childbearing potential unwilling to use contraception
  • History of allergic or hypersensitivity reactions to study drug components

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

West China Hospital, Sichuan University

Chengdu, Sichuan, China, 610041

Actively Recruiting

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Research Team

D

Dan Cao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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