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This study will investigate if Toripalimab (A PD-1 Inhibitor) will improve recurrence-free survival (RFS) compared to placebo in participants with HCC and are at high risk of recurrence after complete resection with no residual of tumour.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | TORIPALIMAB 240mg ,Q3W, up to 16 cycles |
|
| Group B | Placebo Comparator | Placebo 240mg Q3W, up to 16 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TORIPALIMAB INJECTION(JS001 ) | Biological | Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| BICR-RFS | Defined as the time from randomization to the first documented disease recurrence or death. | Time frame is up to 31 months (for interim analysis, up to 44 months for Primary analysis) |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-RFS | the time from randomization to the date of the first documented progressive disease (tumor evlauation by BICR in accordance with RECIST 1.1), or to the date of death for any cause, whichever occurs first | up to 44 months |
| 12-month recurrence-free survival rate (RFS12) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital,Fudan University | 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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probability of patients without recurrence or death for any cause at Month 12 |
| up to 44 months |
| 24-month recurrence-free survival rate (RFS24) | probability of patients without recurrence or death for any cause at Month 24 | up to 44 months |
| Time to recurrence (TTR) | the time from randomization to the first documented disease recurrence | up to 44 months |
| Time to local recurrence (TTLR) | the time from randomization to the first documented local disease recurrence | up to 44 months |
| Overall survival (OS) | the time from randomization to death for any cause | up to 44 months |
| 12- and 24-month overall survival rate (OS12 and OS24) | probability of patients surviving at Month 12 and 24, respectively | up to 44 months |
| Incidence of AEs | Incidence of AEs (including SAEs and AESIs) is evaluated by the investigator, and severity is determined in accordance with CTCAE v5.0 | up to 44 months |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |