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A study to evaluate cadonilimab (AK104) + lenvatinib in combination with transarterial chemoembolization (TACE) versus TACE in participants with incurable/non-metastatic hepatocellular carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | AK104+ Lenvatinib in Combination With Transarterial Chemoembolization (TACE) |
|
| Arm B | Placebo Comparator | Placebo for AK104 + Placebo for Lenvatinib in Combination With TACE |
|
| Arm C | Other | AK104 + Placebo for Lenvatinib in Combination With TACE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Drug | intravenous |
| |
| Lenvatinib |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | PFS is defined as the time from randomization to the first documented progressive disease or death due to any cause, whichever occurs first. Responses are according to RECIST 1.1 as assessed by blinded independent central review (BICR). | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | Up to approximately 2 years |
| PFS per RECIST 1.1 | Assessed by investigators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Liu | Contact | +86 (0760) 8987 3999 | clinicaltrials@akesobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Guoliang Shao, MD | Zhejiang Cancer Hospital | Principal Investigator |
| Gaojun Teng, MD | Zhongda Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450004 | China |
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| Drug |
oral |
|
| TACE | Procedure | TACE (chemo and embolic agent injection into the hepatic artery) |
|
| Placebo for AK104 | Other | intravenous |
|
| Placebo for Lenvatinib | Other | oral |
|
| Up to approximately 2 years |
| Objective Response Rate (ORR) per RECIST 1.1 and Modified Response Evaluation Criteria in Solid Tumors (mRECIST) | Assessed by BICR and investigators | Up to approximately 2 years |
| Duration of Response (DOR) per RECIST 1.1 and mRECIST | Assessed by BICR and investigators | Up to approximately 2 years |
| Disease Control Rate (DCR) per RECIST 1.1 and mRECIST | Assessed by BICR and investigators | Up to approximately 2 years |
| Time to Response (TTR) per RECIST 1.1 and mRECIST | Assessed by BICR and investigators | Up to approximately 2 years |
| Hunan Cancer Hospital | Recruiting | Changsha | Hunan | 410006 | China |
|
| Zhongda Hospital Southeast University | Recruiting | Nanjing | Jiangsu | 210009 | China |
|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310005 | China |
|
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C531958 | lenvatinib |
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