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

Cholangiocarcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438822
• Other study ID #: 2024(791)
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 28, 2024
• Est. completion date: November 30, 2026

Study information

• Verified date: May 2024
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 51
• Est. completion date: November 30, 2026
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Combination Product:
• Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil
cadonilimab at a dosage of 6 mg/kg on day 1 of each 21-day cycle combined with intravenous liposomal irinotecan at a dosage of 70 mg/m2 for 90 min on day 1 plus leucovorin at a dosage of 400 mg/m2 for 30 min on day 1 and fluorouracil at a dosage of 400 mg/m2 for 46 h every 2 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate (ORR)	The total number of participants in the intention-to-treat (ITT) population who achieve a complete response (CR) or partial response (PR) will be considered valid, and the statistical results were used to calculate the ORR based on imaging (CT/MRI) using the RECIST v1.1 criteria.	Up to 2 years