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This is a randomized, open-label, controlled, multicenter Phase III study to evaluate the effectiveness and safety of IBI310 combined with sintilimab and sorafenib 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 had progressive disease after surgical resection or local treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab combined with IBI310 | Experimental |
| |
| Sorafenib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI310 | Drug | IBI310 IV d1, Q6W |
| |
| Sintilimab |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | up to 24 months after randomization | |
| Objective response rate (ORR) | Objective response rate (ORR) in two arms based on RECIST V1.1 by the IRRC | up to 24 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival (PFS) in two arms based on RECIST V1.1 by the IRRC and investigator | up to 24 months after randomization |
| Duration of response(DOR) | Duration of response(DOR) in two arms based on RECIST V1.1 by the IRRC and investigator |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Universtiy Zhongshan Hospital | Shanghai | Shanghai Municipality | 200000 | China |
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| Drug |
sintilimab IV d1, Q3W |
|
| Sorafenib | Drug | Sorafenib 400mg po |
|
| up to 24 months after randomization |
| Disease control rate(DCR) | Disease control rate(DCR) in two arms based on RECIST V1.1 by the IRRC and investigator | up to 24 months after randomization |
| Time to progression(TTP) | Time to progression(TTP) in two arms based on RECIST V1.1 by the IRRC and investigator | up to 24 months after randomization |
| Time to response(TTR) | Time to response(TTR) in two arms based on RECIST V1.1 by the IRRC and investigator | up to 24 months after randomization |
| The incidence and severity of Treatment-Emergent Adverse Events | up to 24 months after randomization |
| 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 |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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