SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma
NCT ID: NCT04560894
Last Updated: 2024-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2/PHASE3
405 participants
INTERVENTIONAL
2020-11-11
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SCT-I10A+SCT510
SCT-I10A
Participants receive SCT-I10A intravenously，200mg，d1，Q3w
SCT510
Participants receive SCT510 intravenously，15mg/kg，d1，Q3w
Sorafenib
Sorafenib 200mg
Participants receive sorafenib orally，400mg bid
Interventions
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SCT-I10A
Participants receive SCT-I10A intravenously，200mg，d1，Q3w
SCT510
Participants receive SCT510 intravenously，15mg/kg，d1，Q3w
Sorafenib 200mg
Participants receive sorafenib orally，400mg bid
Eligibility Criteria
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Inclusion Criteria
* No prior systemic therapy for HCC(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
* Child-Pugh ≤7 , no history of hepatic encephalopathy.
* Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
* At least one measurable lesion based on Recist1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate hematologic and organ function.
Exclusion Criteria
* Prior liver or other organ transplantation.
* Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
* Gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment.
* Hemorrhage tendency or high-risk for bleeding , severe coagulation disorders.
* Active known, or suspected autoimmune disease.
* Any condition that is not suitable for participate in this study as determined by investigator.
18 Years
ALL
No
Sponsors
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Sinocelltech Ltd.
INDUSTRY
Responsible Party
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Locations
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307 Hospital of PLA
Beijing, Beijing Municipality, China
Countries
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References
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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.
Other Identifiers
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SCT-I10A-C301
Identifier Type: -
Identifier Source: org_study_id
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