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To evaluate the efficacy and safety of cadonilimab combined with AK112 as second-line therapy in patients with advanced hepatocellular carcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104+AK112 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104+AK112 | Biological | 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dose climb stage) AK112: 20mg/kg Q3W iv D1 Eligible patients will receive AK104 plus AK112 until disease progression or withdrawn ICF or death, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first drug administration up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1. | From the first drug administration up to two years |
| Disease control Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanqiao Zhang, PhD. | Contact | 13845120210 | yanqiaozhang@126.com | |
| Guangyu Wang, PhD. | Contact | 18249038966 | guangyuwang@hrbmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Hospital | Harbin | China |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
| 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. | From the first drug administration up to two years |
| Incidence of Adverse Events | Use NCI-CTCAE version 5.0 for classification and grading. | From the first drug administration to within 90 days for the last dose |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |