Lenvatinib Combined With TACE and Camrelizumab in Conversion Resection for Advanced Hepatocellular Carcinoma (LEN-TAC Study)

Sponsor
Wen Tianfu
Study ID
NCT05738616
Phase
PHASE3
Status
Recruiting
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Conditions

  • Advanced Hepatocellular Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Lenvatinib combined with TACE and Camrelizumab — COMBINATION_PRODUCT
    Once subjects have signed the informed consent and passed screening, they will be randomized in a 1:1 ratio to either the experimental arm (lenvatinib combined with TACE and camrelizumab) or the control arm (lenvatinib combined with TACE).

Study Details

Compared to systemic therapy alone, conversion therapy is promising to improve the prognosis of patients with advanced hepatocellular carcinoma (HCC). Triple therapy (lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab) may have significant efficacy in conversion therapy for patients with advanced HCC, but its safety and efficacy remain unknown. To address this, we have designed a randomized, open-label, parallel-controlled trial to evaluate the safety and efficacy of lenvatinib combined with transcatheter arterial chemoembolization and camrelizumab versus lenvatinib combined with transcatheter arterial chemoembolization in conversion resection for advanced HCC. Totally 196 patients with BCLC C stage HCC will be rigorously screened and included, and the primary endpoints of the study are overall survival. This study aims to provide valuable insights into new treatment strategies for advanced HCC.

Key Dates

Start date
May 10, 2024
Status verified
Apr 2024
Primary completion
May 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
196 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: lenvatinib combined with TACE and camrelizumab
  • Active Comparator: lenvatinib combined with TACE

Primary Outcome Measure

Overall survival [ Time Frame: 3-year ]

Central Contacts

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