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

Phase 2

Active, not recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: SCT-I10A; Drug: Sorafenib 200mg; Drug: SCT510

• Registration Number: NCT04560894
• Lead Sponsor: Sinocelltech Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-11-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01
• Primary Completion: 2024-04
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 405

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCT-I10A+SCT510	SCT-I10A	-
SCT-I10A+SCT510	SCT510	-
Sorafenib	Sorafenib 200mg	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

307 Hospital of PLA; 🇨🇳 Beijing, Beijing, China