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The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCT-I10A+SCT510 | Experimental |
| |
| Sorafenib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCT-I10A | Drug | Participants receive SCT-I10A intravenously,200mg,d1,Q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | up to 3years | |
| Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1 | up to 3years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | PFS evaluated by investigator based on RECIST V1.1 | up to 3years |
| PFS | PFS evaluated by BICR based on mRECIST. | up to 3years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 307 Hospital of PLA | Beijing | Beijing Municipality | 100071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40769977 | Derived | Zhao C, Zhang Y, Wang G, Zheng J, Chen W, Lu Z, Zhuang L, Gu S, Han L, Zheng Z, Yu Z, Yang Y, Sun H, Wei X, Cheng Y, Lin H, Zhu B, Wu G, Lei K, Wang W, Wang Y, Chen K, Xu X, Zheng C, Bi Y, Ding S, Zhang J, Li W, Liu H, Wang J, Liu X, Du Y, Cai L, Wang J, Luo Z, Xing B, Shen J, Yang L, Wu J, Jiang O, Peng Z, Liu X, Cao B, Shen L, Xu A, Li A, Chen S, Fu T, Chen J, Jin C, Zhang L, Lv J, Zhang C, Zhang X, Wang Y, Su H, Zhou Q, Gai W, Xie L, Xu J. Finotonlimab (PD-1 inhibitor) plus bevacizumab (bevacizumab biosimilar) as first-tier therapy for late-stage hepatocellular carcinoma: a randomized phase 2/3 trial. Signal Transduct Target Ther. 2025 Aug 6;10(1):249. doi: 10.1038/s41392-025-02333-5. |
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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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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| SCT510 |
| Drug |
Participants receive SCT510 intravenously,15mg/kg,d1,Q3w |
|
| Sorafenib 200mg | Drug | Participants receive sorafenib orally,400mg bid |
|
| Objective response rate (ORR) | ORR evaluated by BICR based on RECIST V1.1. | up to 3years |
| ORR | ORR evaluated by BICR based on mRECIST. | up to 3years |
| ORR | ORR evaluated by investigator based on RECIST V1.1 | up to 3years |
| Serum concentration of SCT-I10A and SCT510 | up to 3years |
| Anti-drug antibody (ADA) | up to 3years |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| 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 |