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

Sinocelltech

Status and phase

Active, not recruiting

Phase 3

Phase 2

Conditions

Hepatocellular Carcinoma

Treatments

Drug: SCT-I10A

Drug: Sorafenib 200mg

Drug: SCT510

Study type

Interventional

Funder types

Industry

Identifiers

NCT04560894

SCT-I10A-C301

Details and patient eligibility

About

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.

Enrollment

405 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.