Sorafenib Plus TACE Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced HCC (SOURCE)

  • STATUS
    Recruiting
  • End date
    Sep 15, 2023
  • participants needed
    158
  • sponsor
    Sun Yat-sen University
Updated on 16 February 2022
tyrosine
TACE
sorafenib
chemoembolization

Summary

This trial is a multi-center, phase III, randomized (1:1) clinical trial. The aim is to explore the efficacy and safety of Sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with Sorafenib alone. The primary endpoint is recurrence-free survival. This trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. The patients will be randomized into Sorafenib group and Sorafenib+TACE group as 1:1 ratio.

Details
Condition Hepatocellular Carcinoma
Treatment Sorafenib, Transarterial Chemoembolization
Clinical Study IdentifierNCT04143191
SponsorSun Yat-sen University
Last Modified on16 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Primary hepatocellular carcinoma without any treatments
Received curative hepatic resection
ECOG score 0-1
Child-Pugh grade A
Sufficient liver and kidney function

Exclusion Criteria

Diffused lesions; tumor thrombosis in SMV or IVC
Extra-hepatic metastasis
Contraindication of TACE, like portal-systemic shunt, obvious atherosclerosis, etc
Allergic to the contrast agent of TACE
Dysfunction of liver, kidney or bone marrow
Concomitant other malignant tumor or HIV infection
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