A Phase III Randomized Study of TACE Plus an Oral Triple-Agent Cocktail Versus TACE Plus First-Line Targeted Immunotherapy in Unresectable Hepatocellular Carcinoma

Sponsor
Shanghai Zhongshan Hospital
Study ID
NCT07309419
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib: 250m, po, QD
  • Camrelizumab — DRUG
    Camrelizumab: 200mg, iv, Q3W
  • TACE — DEVICE
    TACE if necessary
  • Thalidomide (drug) — DRUG
    Thalidomide：50-75mg, PO, qn;
  • Capecitabine — DRUG
    Capecitabine: 500mg, PO, bid
  • Compound cantharides capsule — DRUG
    Compound cantharides capsule: 750mg, PO, tid

Study Details

This is a prospective, multicenter, randomized, open-label phase 3 study evaluating the efficacy and safety of transarterial chemoembolization (TACE) combined with a triple oral cocktail regimen versus TACE combined with targeted therapy plus immunotherapy as first-line treatment for unresectable hepatocellular carcinoma (HCC).

Key Dates

Start date
Dec 22, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2030
Completion
Jun 30, 2030

Study Design

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

Arms

  • Active Comparator: Arm A: apatinib + camrelizumab + TACE
    Participants will receive apatinib plus camrelizumab on Day 1 of a 21-Day cycle, after every on-demand transarterial chemoembolization procedure.
  • Experimental: Arm B: Thalidomide + Capecitabine + Compound cantharides capsule + TACE
    Participants assigned to this arm will receive an oral triple-agent regimen consisting of thalidomide, capecitabine, and compound cantharides capsules. The oral regimen will be initiated immediately after the initial transarterial chemoembolization (TACE) procedure and administered continuously thereafter.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to ~4 years ]

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