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CompletedNCT04103398TREATUpdated Feb 28, 2024

TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma

A Phase 3 interventional study of TACE+sorafenib and TACE in Hepatocellular Carcinoma, Sorafenib and Transarterial Chemoembolization, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-28.

Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
162
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The study is a multicenter phase III randomized trial. The purpose is to investigate both the efficacy and safety of transarterial chemoembolization (TACE) plus sorafenib versus TACE alone for recurrent intermediate hepatocellular carcinoma patients.

Read the detailed description

The trial will recruit 162 patients with recurrent intermediate HCC, and they will be randomized (1:1) into two groups (TACE+sorafenib group, TACE group). Patients in TACE+sorafenib group will receive TACE one day following oral sorafenib (initial dose: 400mg BID). Patients in the TACE group will receive TACE alone.

02

Conditions studied

  • Hepatocellular Carcinoma
  • Sorafenib
  • Transarterial Chemoembolization
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 162 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age: 18-75 years;
  2. Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis;
  3. Initial tumor recurrence following curative surgical resection (R0 hepatectomy) (two to three lesions with at least one lesion >3 cm in diameter or more than three lesions of any diameter). Tumor burden ≤ 50% and no distant metastasis and macroscopic vascular invasion;
  4. Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor;
  5. Eastern Cooperative Oncology Group scoring 0-1;
  6. Child-Pugh A class;
  7. At least 3 months of life expectancy;
  8. Adequate hematologic, hepatic and renal function: absolute neutrophil count ≥ 1.5x10\^9/L, platelet ≥ 60 x10\^9/L, Hb ≥ 90g/L, albumin ≥ 30g/L, total bilirubin ≤ 1.5 x upper limit of normal (ULN) , ALT \< 5×ULN, AST \< 5×ULN, alkaline phosphatase \< 4×ULN, extended prothrombin time not exceeding 6s of ULN, creatine\<1.5×ULN.

Exclusion criteria

Exclusion Criteria:

  1. Have lesions which are diffuse or can not be evaluated via imaging. Tumor burden>50%;
  2. Have a history of hepatic encephalopathy, refractory ascites, severe esophageal and gastric varices or variceal bleeding and obstructive jaundice;
  3. Have contraindications for TACE;
  4. Have metastasis in central nervous system;
  5. Allergic to intravenous contrast agents;
  6. Pregnant or breastfeeding women, or expecting to conceive or father children within two years;
  7. Infection of HIV, known syphilis requiring treatment;
  8. Have a known history of prior invasive malignancies within 5 years before enrolment;
  9. Patients with allotransplantation;
  10. Severe dysfunction involving heart, kidney or other organs;
  11. Severe active clinical infection which is over grade 2 based on NCI-CTC version 4;
  12. Patients with mental disorders which may impact informed consent;
  13. Unable to orally take drugs;
  14. Participating other clinical drug trials 12 months before enrolment.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
162 participants (actual)

Study arms

  • Experimental
    Transarterial chemoembolization combined with sorafenib

    The initial dose of sorafenib is 400mg BID and the drug therapy will last till outcome events happen or the trial ends. TACE will start one day following oral sorafenib. Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (doxorubicin 50mg for cTACE or 75mg for dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

    Combination Product: TACE+sorafenib

  • Active comparator
    Transarterial chemoembolization alone

    Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (oxaliplatin 200mg, raltitrexed 4mg, epirubicin 20mg in cTACE or 70mg in dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

    Procedure: TACE

Interventions

  • Combination productTACE+sorafenib

    The initial dose of sorafenib is 400mg BID and the drug therapy will last till outcome events happen or the trial ends. TACE will start one day following oral sorafenib. Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (doxorubicin 50mg for cTACE or 75mg for dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

  • ProcedureTACE

    Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (doxorubicin 50mg for cTACE or 75mg for dTACE) and embolizing agents (gelatin sponge for cTACE or microsphere for dTACE) into blood vessels that help tumor grow.

06

What researchers measure

Primary outcomes

  1. Overall Survival

    Defined as the time from randomization until death from any cause. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive. Patients remaining alive throughout the duration of the study will have their survival time censored on the date last seen alive.

    Time frame: 2 years

Secondary outcomes

  1. Progression Free Survival

    Defined as the time from randomization until disease progression or death from any cause, whichever happens first. Patients who withdraw or who are lost to follow-up will be censored at the date last known to be alive and progression free. Patients not having an event will be censored at the date last seen alive.

    Time frame: 2 years

  2. Time To Progression

    Defined as the time from randomization until disease progression.

    Time frame: 2 years

  3. Objective Response Rate

    The ratio of patients with complete response or partial response among all patients.

    Time frame: 2 years

  4. Disease Control Rate

    The ratio of patients with complete response, partial response or stable disease among all patients.

    Time frame: 2 years

  5. Adverse Events

    Grade 3 or severer hematological or non-hematological adverse events during the treatment period using Common Terminology Criteria for Adverse Events (CTCAE) (version 4).

    Time frame: 2 years

  6. Scoring of Quality of Life

    Using the third edition of European Organisation for Research and Treatment of Cancer (EORTC) QOL questionnaire (QLQ-C30).

    Time frame: 2 years

07

Study locations

1 site
  • The First Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510080, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04103398
Lead sponsor
Sun Yat-sen University
Responsible party
Ming Kuang (The vice president, Sun Yat-sen University) — Principal investigator
First posted
Sep 25, 2019
Start date
Oct 2, 2019
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023
Last update
Feb 28, 2024

Study contacts

Ming Kuang, PhD
study chair · First Affiliated Hospital, Sun Yat-Sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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