Clinical trial · Interventional
SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma
SCT-I10A in Combination With SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma (HCC): A Multicenter, Randomized, Open-label,Phase 2/3 Trial
NCT04560894CI-TRIAL-00073527HCCunknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SCT510 | Drug | — | UNRESOLVED |
| SCT-I10A | Drug | — | UNRESOLVED |
| Sorafenib 200mg | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SCT-I10A+SCT510
- interventionNames
- Drug: SCT-I10A
- Drug: SCT510
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- interventionNames
- Drug: Sorafenib 200mg
Primary outcomes (2)
- measure
- Overall survival (OS)
- timeFrame
- up to 3years
- measure
- Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants must have a diagnosis of HCC not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment. * 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: * Local treatment or surgery for liver lesions within 4 weeks. * 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.
References
Publications (1)
- DERIVEDZhao 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. PMID 40769977