Combining cadonilimab with chemotherapy for advanced bile duct cancer

Second-line Treatment of PD-1 and CTLA-4 Blockade Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma: a Single-arm, Prospective Phase II Trial

This study is testing if combining a new drug called cadonilimab with chemotherapy can help people with advanced bile duct cancer who haven't responded to other treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: chemotherapy, prednisone, cadonilimab
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06438822 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced bile duct cancer that has progressed after gemcitabine-based chemotherapy.

Not a fit: Patients with resectable tumors or those who have not progressed after initial gemcitabine treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced cholangiocarcinoma who have limited treatment alternatives.

How similar studies have performed: While this specific combination has not been widely tested, similar approaches using immunotherapy and chemotherapy have shown promise in other cancer types.

Eligibility criteria

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 this trial is running

Chengdu, Sichuan

• West China Hospital, Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Dan Cao

Conditions Cholangiocarcinoma