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

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sinocelltech Ltd.
• Treatments: Sorafenib

Criteria

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.