Combining cadonilimab with chemotherapy for advanced bile duct cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of cadonilimab when combined with liposomal irinotecan, leucovorin, and fluorouracil in patients with advanced cholangiocarcinoma. It targets individuals who have not responded to previous gemcitabine-based chemotherapy and have specific measurable tumor lesions. The study aims to provide a new treatment option for patients with locally advanced unresectable or metastatic bile duct cancer.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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;
2. Progression after prior gemcitabine-based systemic chemotherapy and refused or were intolerable to initial treatment with gemcitabine-based chemotherapy regimens;
3. At least one measurable objective lesion of the tumor according to the RECIST version 1.1 criteria, which must have a maximum diameter of ≥1 cm for spiral CT or ≥2 cm for plain CT or MRI; and should be performed within 28 days prior to enrollment;
4. Aged 18 to 75 years old;
5. Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1;
6. Life expectancy of greater than 3 months;
7. Must be able to participate the study voluntarily and sign the informed consent document;
8. Adequate organ and bone marrow function as below:

Absolute neutrophil count ≥1.5\*109/L , platelet count ≥75\*109/L , hemoglobin ≥90g/L; Alanine aminotransferase, and aspartate aminotransferase ≤2.5 × upper limit of normal; Total bilirubin and serum creatinine ≤1.5 × upper limit of normal.

Exclusion Criteria:

1. Disease-free survival within 5 years due to other malignancies (except for adequately treated basal cell carcinoma of the skin and carcinoma in situ of the cervix);
2. Serious or uncontrolled infectious disease (HIV, HBV DNA \> 500IU/ml);
3. Severe uncontrolled acute infection (infection causing a fever of 38℃ or higher)；
4. Severe hepatic or renal insufficiency; or recent history of myocardial infarction (within 3 months)；
5. Current or past autoimmune disease and susceptibility to its reoccurrence;
6. Serious or uncontrolled pleural effusion or ascites;
7. Subjects with a history of active tuberculosis infection within 1 year prior to the first administration of study drug. If in the judgment of the investigator, subjects with more than 1 year prior to the first administration of study drug were considered suitable for enrollment; Subjects with a long history of chronic diarrhea or the presence of complete intestinal obstruction;
8. Subjects requiring systemic therapy with corticosteroids (\> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs within 14 days prior to administration of study drug.
9. Combined with other serious medical and surgical conditions that affected organ function;
10. Participated in other clinical trial within 4 weeks;
11. Pregnant or breastfeeding women or subjects of childbearing potential (males or females with less than 1 year of menopause) who were unwilling to use contraception;
12. Subjects with a history of allergic or hypersensitivity reactions to components of the study drug;

Where it's running

• West China Hospital, Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Dan Cao
• Email: caodan@scu.edu.cn
• Phone: 86-28-85422589

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.