CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 51 target
Drug / intervention
Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracilcombination
Likely dose
Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil 6 mg/kgfrom record
Key inclusion· 6
  • Pathologically confirmed locally advanced unresectable or metastatic adenocarcinoma of bile ducts, gallbladder, or cholangiocellular carcinoma
  • Primary tumors in intrahepatic, hilar, distal bile ducts, or gallbladder
  • Aged 18 to 75 years old
  • At least one measurable lesion ≥1 cm (spiral CT) or ≥2 cm (plain CT/MRI) per RECIST v1.1
Key exclusion· 14
  • Disease-free survival within 5 years from other malignancies (except adequately treated basal cell carcinoma or cervical carcinoma in situ)
  • Serious or uncontrolled infectious disease (HIV, HBV DNA >500IU/ml)
  • Severe uncontrolled acute infection with fever ≥38°C
  • Severe hepatic or renal insufficiency

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06438822
NCT06438822Phase 2RecruitingOn TrackUpdated 13mo ago

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

West China Hospital·interventional·Posted Jun 3, 2024·Updated May 7, 2025

In Brief

A Phase 2 clinical trial evaluating Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracil for Cholangiocarcinoma. Currently recruiting, targeting 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2Recruiting
202520262027
First PostedJun 3, 2024
Enrollment StartAug 30, 2024
Primary CompletionAug 30, 2026
Study CompletionNov 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 2.1 years agoPrimary completion in 2 months

Interventions

Cadonilimab Combined With Liposomal Irinotecan Plus Leucovorin and Fluorouracilcombination

cadonilimab at a dosage of 6 mg/kg on day 1 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 2400 mg/m2 for 46 h every 2 weeks.