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Trial Title:
Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Advanced Cholangiocarcinoma
NCT ID:
NCT06438822
Condition:
Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Leucovorin
Fluorouracil
Irinotecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil
Description:
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.
Arm group label:
Cadonilimab+NIFU regimen
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 28, 2024
Completion date:
November 30, 2026
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06438822
