A Phase 2 interventional study of AK104+AK112 in Hepatocellular Carcinoma, sponsored by Harbin Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-09.
Sponsored by Harbin Medical University · Phase 2, Interventional, and Treatment
To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 36 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Harbin Medical University is the lead sponsor of 87 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: AK104+AK112
Cadonilimab (AK104): 10mg/kg or 15mg/kg Q6W iv D8 (dose choosing depends on the outcome of the dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first.
Progression-Free-Survival
Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.
Time frame: From the first drug administration up to two years
Objective Response Rate
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Time frame: From the first drug administration up to two years
Disease control Rate
Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
Time frame: From the first drug administration up to two years
Overall survival
Defined as the time between the first dose to death due to any causes.
Time frame: From the first drug administration up to two years
Incidence of Adverse Events
Use NCI-CTCAE version 5.0 for classification and grading.
Time frame: From the first drug administration to within 90 days for the last dose
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Harbin Medical University