Researchers are gearing up for a clinical trial that could potentially change how we approach intrahepatic cholangiocarcinoma (ICC) treatment. The phase 2 clinical trial is expected to be completed by December 1, 2023. The study aims to evaluate the safety and efficacy of combining cadonilimab with gemcitabine and cisplatin (Gem/Cis) as first-line therapy in patients with advanced ICC.
A total of 64 participants will be evaluated for a follow-up period of 2 years. The inclusion criteria for participants are such that they should be adults 18 to 75 years of age, be histologically or cytologically diagnosed with ICC, have at least 1 measurable lesion, haven’t received any systemic treatment previously, have adequate medullary hematopoiesis function, renal function and hepatic function, and those with no cardiac insufficiency or chest pain. They must also have an expected survival time of over 3 months.
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Eligible participants will receive cadonilimab (up to 12 months) in combination with gemcitabine and cisplatin (for a maximum of 6 to 8 cycles) until withdrawal from the study, the occurrence of unacceptable toxicity, or radiologic disease progression, whichever occurs first.
The primary outcome of the study is the objective response rate, while the secondary outcomes include disease control rate, progression free survival, adverse events, overall survival, and 6-month progression free survival rate per RECIST 1.1.
An earlier study, TOPAZ-1 phase 3, conducted earlier revealed that using an antiPD-L1 antibody as an immune checkpoint inhibitor alongside Gem/Cis results in enhanced progression-free survival and overall survival. Cadonilimab is a novel bispecific antibody of the IgG1 class that targets both PD-1 and CTLA-4 and can potentially increase tumor immune surveillance.
With limited standard treatment options currently available for this disease, the results of this clinical trial study hold promise for patients seeking an improved quality of life and extended survival.
Cadonilimab combined with GEM/CIS as first line therapy in patients with advanced ICC. ClinicalTrials.gov. March 23, 2023. Accessed April 11, 2023.