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To evaluate the efficacy and safety of AK104 plus lenvatinib combined with on-demand TACE in participants with unresectable, non-metastatic hepatocellular carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104+Lenvatinib+TACE | Experimental | Participants will receive AK104 IV every 3 weeks (Q3W) and Lenvatinib 12mg weight≥60kg or 8mg weight<60kg,PO QD The first Transarterial chemoembolization will be performed at the beginning of study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Biological | Subjects will receive AK104 until disease progression or for a maximum of 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, which ever occurs first. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR | ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1. | Up to 2 years |
| Disease control rate (DCR) | The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoliang Shao, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Beijing University | Beijing | Beijing Municipality | 100034 | China | ||
| Nanfang Hospital, Southern Medical University |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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| Lenvatinib | Drug | Subjects will receive lenvatinib until disease progression or for a maximum of 24 months |
|
| TACE | Procedure | On demand TACE |
|
| Up to 2 years |
| Duration of response (DoR) | Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first | Up to 2 years |
| Number of participants with adverse events (AEs) | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. | the time of informed consent signed through 90 days after the last dose |
| Guangzhou |
| Guangdong |
| 510515 |
| China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450003 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |