SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma

Conditions

Hepatocellular Carcinoma

Brief summary

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.

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.

2025-08-062 citations

10.1038/s41392-025-02333-5

SCT-I10A combined with a bevacizumab biosimilar (SCT510) versus sorafenib in the first-line treatment of advanced hepatocellular carcinoma: A randomized phase 3 trial.

Jianming Xu, Yanqiao Zhang, Gang Wang, Weiqing Chen, Zhuang Li et al. (19 authors)

Journal of Clinical Oncology2024-06-0112 citations

10.1200/jco.2024.42.16_suppl.4092

Interventions

DRUGSCT-I10A

Participants receive SCT-I10A intravenously，200mg，d1，Q3w

DRUGSCT510

Participants receive SCT510 intravenously，15mg/kg，d1，Q3w

DRUGSorafenib 200mg

Participants receive sorafenib orally，400mg bid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame	Description
ORR	up to 3years	ORR evaluated by BICR based on mRECIST.
PFS	up to 3years	PFS evaluated by investigator based on RECIST V1.1
Anti-drug antibody (ADA)	up to 3years	—
Serum concentration of SCT-I10A and SCT510	up to 3years	—
Objective response rate (ORR)	up to 3years	ORR evaluated by BICR based on RECIST V1.1.

Countries

China

Outcome results

None listed