NCT05781958

Cadonilimab Combined With Gem/Cis as First Line Therapy in Patients With Advanced ICC

Cadonilimab Combined With Gemcitabine and Cisplatin as First Line Therapy in Patients With Advanced Intrahepatic Cholangiocarcinoma: A Single Center, Single Arm, Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Shen Feng · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

TOPAZ-1 phase III trail demonstrated that the addition of immune checkpoint inhibitor anti-PD-L1 antibody improved progression-free survival (PFS) and overall survival (OS) compared to Gem/Cis alone. Cadonilimab is a first-in-class bispecific, humanized IgG1 antibody targeting PD-1 and CTLA-4, which has the potential to boost immune surveillance in tumors. The goal of this clinical trial is to evaluated the efficacy and safety of cadonilimab combined with gemcitabine and cisplatin as first Line therapy in patients with advanced intrahepatic cholangiocarcinoma. Eligible participants will receive cadonilimab (up to 12 months) plus gemcitabine and cisplatin (for maximum of 6-8 cycles) until radiologic disease progression, unacceptable toxicity, or withdrawal from the study, whichever occurred first. The primary endpoint is objective response rate.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Cadonilimab+Gem/Cis	Cadonilimab (500mg, iv, Q3W, Day1) with gemcitabine(1000mg/m\^2, iv, Q3W, Day1and Day8) plus cisplatin(25mg/m\^2, iv, Q3W, Day1and Day8) up to 8 cycles followed by cadonilimab (500mg, iv, Q3W, Day1) plus capecitabine（1000 mg/m\^2 orally according to Body Surface Area (BSA)，BID，Q3W，on Days 1-14）as maintenance therapy until disease progression or other discontinuation criteria, up to 24months.

Timeline

• Start date: 2022-11-24
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2023-03-23
• Last updated: 2023-11-02

Locations

1 site across 1 country: China