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

Hepatocellular Carcinoma Clinical Trial

— HCC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04560894
• Other study ID #: SCT-I10A-C301
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: November 11, 2020
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Sinocelltech Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 405
• Est. completion date: September 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	307 Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sinocelltech Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		up to 3years
Primary	Progression-free survival(PFS)evaluated by the Blinded Independent Central Review Committee (BICR) based on RECIST V1.1		up to 3years
Secondary	PFS	PFS evaluated by investigator based on RECIST V1.1	up to 3years
Secondary	PFS	PFS evaluated by BICR based on mRECIST.	up to 3years
Secondary	Objective response rate (ORR)	ORR evaluated by BICR based on RECIST V1.1.	up to 3years
Secondary	ORR	ORR evaluated by BICR based on mRECIST.	up to 3years
Secondary	ORR	ORR evaluated by investigator based on RECIST V1.1	up to 3years
Secondary	Serum concentration of SCT-I10A and SCT510		up to 3years
Secondary	Anti-drug antibody (ADA)		up to 3years