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

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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 refused or were intolerable to initial treatment with gemcitabine-based chemotherapy regimens;

• 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;

• Aged 18 to 75 years old;

• Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1;

• Life expectancy of greater than 3 months;

• Must be able to participate the study voluntarily and sign the informed consent document;

• 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.

Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Dan Cao
caodan@scu.edu.cn
86-28-85422589
Time Frame
Start Date: 2024-08-30
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 51
Treatments
Experimental: Cadonilimab+NIFU regimen
There will be two cohorts. Cohort 1 includes patients who have failed first-line treatment with gemcitabine-based chemotherapy combined with PD-L1/PD-1 monoclonal antibody immunotherapy. Cohort 2 includes patients who have failed chemotherapy with gemcitabine-based chemotherapy as a first-line treatment and who had not been treated with PD-L1/PD-1 monoclonal antibody immunotherapy.
Related Therapeutic Areas
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov