Phase IIa Study of CVM-1118 with Sintilimab and TACE in Adults with Incurable Non-metastatic Hepatocellular Carcinoma

What this Trial Is About

This trial is a Phase IIa, single-arm, open-label study evaluating the combination of CVM-1118 with Sintilimab and transarterial chemoembolization TACE in adults with incurable, non-metastatic hepatocellular carcinoma HCC. The goal is to assess the efficacy, safety, and pharmacokinetics of this combination treatment in participants who cannot undergo curative surgery or transplantation. The study is conducted in China and aims to support future U.S. marketing applications for the investigational drugs. Participants will receive CVM-1118 orally at 200 mg twice daily and Sintilimab intravenously at 200 mg every three weeks. The TACE procedure, either conventional or drug-eluting beads, will be performed up to four times per participant with specific limits per lesion and intervals between treatments. Treatment continues until unacceptable side effects, disease progression, death, withdrawal of consent, or for up to two years. CVM-1118 dosing is paused around TACE procedures to reduce risks associated with the procedure. During the study, participants will undergo tumor assessments every nine weeks using RECIST criteria, pharmacokinetic blood sampling, and regular safety evaluations. After treatment ends, a safety follow-up occurs 28 days post-treatment, followed by survival follow-up every 12 weeks until death or study closure. Researchers will measure objective response rates, disease control, duration of response, progression-free and overall survival, as well as adverse events and pharmacokinetic parameters.

A Phase IIa, Single-arm, Open-label Clinical Study to Evaluate the Efficacy, Safety and PK of CVM-1118 in Combination With Sintilimab and TACE in Participants With Incurable/Non-metastatic HCC