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This is a randomized, open-label, multicenter Phase Ib study to evaluate the effectiveness and safety of different doses of IBI310, bevacizumab combined with sintilimab in patients with locally advanced or metastatic HCC who have not previously received systemic therapy, are unsuitable for radical surgical resection or local treatment, or have progressive disease after surgical resection or local treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A(IBI310 0.5mg/kg) | Experimental | IBI310 0.5mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1,Q3W |
|
| Arm B(IBI310 0.3mg/kg) | Experimental | IBI310 0.3mg/kg IV d1 Q6W, sintilimab 200mg IV d1 Q3W, combined with bevacizumab 15mg/kg IV d1,Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI310(0.5mg/kg) | Drug | IBI310 0.5mg/kg IV d1 Q6W |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | efficacy | The proportion of patients with complete response or partial response, through study completion, an average of 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response(DOR)according to RECIST V1.1 criteria | efficacy | From date of randomization until the date of first documented progression, up to 48 months |
| Duration of Response(DOR)according to mRECIST criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| IBI310(0.3mg/kg) |
| Drug |
IBI310 0.3mg/kg IV d1 Q6W |
|
| sintilimab | Drug | sintilimab 200 mg IV d1 Q3W |
|
| bevacizumab | Drug | bevacizumab 15 mg/kg IV d1,Q3W |
|
efficacy
| From date of randomization until the date of first documented progression, up to 48 months |
| Disease Control Rate(DCR) according to RECIST V1.1 criteria | efficacy | The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years |
| Disease Control Rate(DCR) according to mRECIST criteria | efficacy | The percentage of patients whose therapeutic intervention has led to a complete response, partial response, or stable disease, through study completion, an average of 3 years |
| Time to Progression(TTP)according to RECIST V1.1 criteria | efficacy | From date of randomization until the date of first documented progression, up to 48 months |
| Time to Progression(TTP)according to mRECIST criteria | efficacy | From date of randomization until the date of first documented progression, up to 48 months |
| Progresison Free Surviva(PFS)according to RECIST V1.1 criteria | efficacy | From date of randomization until the date of the first documented progression or date of death from any cause, whichever comes first, up to 48 months |
| Progresison Free Surviva(PFS)according to mRECIST criteria | efficacy | From date of randomization until the date of the first documented progression or date of death from any cause, whichever comes first, up to 48 months |
| Overall survival (OS) | efficacy | From date of randomization until death from any cause,through study completion, an average of 3 years |
| Immune Best Overall Response(iBOR)according to iRECIST criteria | efficacy | The best timepoint response recorded from the start of the study treatment until the end of treatment, taking into account any requirement for confirmation, through study completion, an average of 3 years |
| 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 |
|---|---|
| C000632826 | sintilimab |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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