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This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection
There is no stardard adjuvant treatment for HCC. This study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after radical resection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W |
|
| Arm B | No Intervention | Active surveillance |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab 200mg IV Q3W |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free Survival (RFS) | RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death due to any cause (whichever occurs first). | up to 36 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the time from the date of randomisation until death due to any cause | up to 48 months after randomization |
| RFS Rate at 12 and 24 months | RFS rate defined as the proportion of patients without recurrence or death from any cause at 12 and 24 months after randomization. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongguo Zhou | Contact | 020-87343585 | 54757370@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Bevacizumab | Drug | Bevacizumab 7.5mg/kg IV Q3W |
|
|
| at 12 and 24 months after randomization |
| OS Rate at 24 and 36 Months | OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization. | at 24 and 36 months after randomization |
| TTR(time to recurrence) | TTR is defined as the time the date of randomisation until first documented disease recurrence. | up to 36 months after randomization |
| Adverse Events (AEs) | The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v5.0 from the date of randomization to 90 days after last dose of study treatment. | up to 48 months after randomization |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |