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

This is a single-arm, open-label Phase IIa study designed to evaluate the efficacy, safety, and PK of CVM-1118 in combination with Sintilimab (Tyvyt ®) and TACE in participants with incurable/non-metastatic HCC. Approximately 40 participants will be enrolled, all receiving CVM-1118 (200 mg orally \[PO\], twice daily \[BID\]) in combination with Sintilimab (200 mg via intravenous \[IV\] infusion every 3 weeks \[Q3W\]) and TACE. All participants will initiate treatment with CVM-1118 and Sintilimab on Cycle 1 Day 1 (C1D1), with each cycle lasting 21 days, continuing until the occurrence of unacc

Trial Details

NCT ID
NCT07521852
Phase
PHASE2
Sponsor
TaiRx, Inc.
Status
RECRUITING
Cancer Type
Hepatocellular Carcinoma (HCC) Liver Cancer
Interventions
  • CVM-1118 + Sintilimab + TACE
Locations (sample)
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • 1\) Participant is ≥18 years of age, at the time of providing the documented informed consent.
  • 2\) Diagnosis of hepatocellular carcinoma
  • Pathologically or cytologically-confirmed or clinically diagnosed in accordance with American Association for the Study of Liver Diseases (AASLD) c…
  • 3\) No evidence of extrahepatic disease on any available imaging. 4) Disease not amenable to curative surgery or transplantation or curative ablation.

For full eligibility, visit ClinicalTrials.gov.

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