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The purpose of the study is to assess the safety, tolerability and effectiveness of Sintilimab in combination with IBI305 in patients with HCC as the first-line treatment compared with Sorafenib. This study is a randomised, Open-label，Multi-center Study. The primary endpoint is overall survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab +IBI305 | Experimental |
| |
| Sorafenib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | 200mg IV d1， Q3W |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | up to 24 months after randomization | |
| Progression-free survival (PFS) | Progression-free survival (PFS) in two arms based on RECIST V1.1 by Independent Radiological Review Committee, IRRC. | up to 24 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS in two arms based on RECIST V1.1 by investigator. | up to 24 months after randomization |
| Objective response rate (ORR) | Objective response rate (ORR) in two arms based on RECIST V1.1 by IRRC and investigator . |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34143971 | Derived | Ren Z, Xu J, Bai Y, Xu A, Cang S, Du C, Li Q, Lu Y, Chen Y, Guo Y, Chen Z, Liu B, Jia W, Wu J, Wang J, Shao G, Zhang B, Shan Y, Meng Z, Wu J, Gu S, Yang W, Liu C, Shi X, Gao Z, Yin T, Cui J, Huang M, Xing B, Mao Y, Teng G, Qin Y, Wang J, Xia F, Yin G, Yang Y, Chen M, Wang Y, Zhou H, Fan J; ORIENT-32 study group. Sintilimab plus a bevacizumab biosimilar (IBI305) versus sorafenib in unresectable hepatocellular carcinoma (ORIENT-32): a randomised, open-label, phase 2-3 study. Lancet Oncol. 2021 Jul;22(7):977-990. doi: 10.1016/S1470-2045(21)00252-7. Epub 2021 Jun 15. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 21, 2021 | |
| Reset | Aug 16, 2021 |
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| IBI305 | Drug | 15mg/kg IV d1， Q3W |
|
|
| Sorafenib | Drug | 400mg PO BID |
|
| up to 24 months after randomization |
| Disease control rate (DCR) | DCR in two arms based on RECIST V1.1 by IRRC and investigator. | up to 24 months after randomization |
| Duration of response (DOR) | DOR in two arms based on RECIST V1.1 by IRRC and investigator. | up to 24 months after randomization |
| Time to progression (TTP) | TTP in two arms based on RECIST V1.1 by IRRC and investigator. | One assessment was performed every 6 weeks (±7 days) from the time of randomization, and once every 12 weeks (±7 days) after 48 weeks. |
| Time to response (TTR) | TTR in two arms based on RECIST V1.1 by IRRC and investigator. | up to 24 months after randomization |
| PFS | PFS in two arms based on mRECIST by IRRC. | up to 24 months after randomization |
| Objective response rate (ORR) | Objective response rate (ORR) in two arms based on mRECIST by IRRC. | up to 24 months after randomization |
| Time to progression (TTP) | TTP in two arms based on mRECIST by IRRC. | up to 24 months after randomization |
| Duration of response (DOR) | DOR in two arms based on mRECIST by IRRC. | up to 24 months after randomization |
| Disease control rate (DCR) | DCR in two arms based on mRECIST by IRRC. | up to 24 months after randomization |
| Time to response (TTR) | TTR in two arms based on mRECIST by IRRC. | up to 24 months after randomization |
| Anti-drug antibody (ADA) | Immunogenicity measured by anti-drug antibody (ADA) for Sintilimab and IBI305. | up to 24 months after randomization |
| EORTC QLQ-C30 | up to 24 months after randomization |
| EORTC QLQ-HCC18 | up to 24 months after randomization |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 21, 2021 | Aug 16, 2021 |
| 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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