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The efficacy and safety of AK104 as adjuvant therapy in hepatocellular carcinoma of high recurrence risk after curative resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK104 | Active Comparator | AK104 IV every three weeks |
|
| placebo | Placebo Comparator | Placebo IV every three weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK104 | Biological | Subjects will receive AK104 until disease progression or for a maximum of 16 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence free survival (RFS) by BICR | The time comfirmed by BICR from randomization to recurrence or death. | Up to 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| 12-months recurrence free survival (RFS-12) | The proportion of patients without recurrence or death at 12 month. | 12 months |
| 24-months recurrence free survival (RFS-24) | The proportion of patients without recurrence or death at 24 month. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Liu, M.D. | Contact | (0760)89873999 | clinicaltrials@akesobio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Fan, Ph.D. | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | 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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| placebo | Biological | Subjects will receive placebo until disease progression or for a maximum of 16 cycles |
|
| 24 months |
| Time to recurrence (TTR) | The time from randomization to recurrence. | Up to 48 months |
| Overall survival (OS) | The time from randomization to death for any reason. | Up to 48 months |
| Types and proportions of adverse events (AEs) | Up to 48 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |