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

NCT07309419 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2025-12-30

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Apatinib

Apatinib: 250m, po, QD

DRUG

Camrelizumab

Camrelizumab: 200mg, iv, Q3W

DEVICE

TACE

TACE if necessary

DRUG

Thalidomide (drug)

Thalidomide：50-75mg, PO, qn;

DRUG

Capecitabine

Capecitabine: 500mg, PO, bid

DRUG

Compound cantharides capsule

Compound cantharides capsule: 750mg, PO, tid

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-22
Primary Completion
2030-06-30
Completion
2030-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07309419 on ClinicalTrials.gov