NCT06648525

Adebrelimab Combined with Irinotecan Liposomes, 5-FU, CF ± Lenvatinib As First-line Treatment for Advanced ICC

Adebrelimab Combined with Irinotecan Liposomes, 5-fluorouracil, Calcium Folinate ± Lenvatinib As First-line Treatment for Advanced Intrahepatic Cholangiocarcinoma: a Prospective Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (estimated)
• Sponsor: Harbin Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, open label, randomized, two-arm clinical study to observe and evaluate the efficacy and safety of adebrelimab combined with irinotecan liposomes, 5-fluorouracil, calcium folinate ± lenvatinib as first-line treatment for advanced intrahepatic cholangiocarcinoma (ICC).

Detailed description

This study plans to recruit 68 patients with unresectable ICC who have not received prior systematic treatment. The patients will be randomly divided into two groups. Group A: patients will receive adebrelimab+irinotecan liposomes+5-fluorouracil+calcium folinate+lenvatinib; Group B: patients will receive treatment with adebrelimab+irinotecan liposomes+5-fluorouracil+calcium folinate. The combination of irinotecan liposomes+5-fluorouracil+calcium folinate will be used 9 times (Q2W), and adebrelimab ± lenvatinib will be used until disease progression or medication for 2 years.

Conditions

• Intrahepatic Cholangiocarcinoma (Icc)

Interventions

Type	Name	Description
DRUG	Adebrelimab	Adebrelimab, IV
DRUG	Irinotecan liposomes	Irinotecan liposomes, IV
DRUG	Lenvatinib	Lenvatinib, po
DRUG	5-Fluorouracil (5-FU)	5-Fluorouracil (5-FU), IV
DRUG	Calcium Folinate	Calcium folinate, IV

Timeline

• Start date: 2024-10-01
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2024-10-18
• Last updated: 2024-10-18

Locations

1 site across 1 country: China