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Hepatocellular CarcinomaPhase 3SOURCENCT04143191

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

A Phase 3 study testing Sorafenib and Transarterial chemoembolization in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sorafenib and Transarterial chemoembolization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
158 participants
Where
1 siteChina
Study dates
15 Sep 2019to 15 Sep 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Ming Kuang, MD, PhD. contact

008687755766 ext. 8576

kuangm@mail.sysu.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    Ming Kuang, Ph.D., 008687755766 ext. 8576, kuangm@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Sorafenib Plus Transarterial Chemoembolization Versus Sorafenib Alone as Postoperative Adjuvant Treatment for Resectable Primary Advanced Hepatocellular Carcinoma: A Phase 3, Multicenter, Randomized Controlled Trial

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.

Being tested
Sorafenib, Transarterial chemoembolization
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SorafenibDrug

    Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.

  • Transarterial chemoembolizationProcedure or surgery

    Also called TACE

    TACE including conventional TACE (cTACE) and DEB-TACE. Treatment choices are according to the specific condition of each patient and the experience of interventional radiologists.

Study groups in NCT04143191
Study groupRoleWhat they receive
SorafenibActive comparatorPatients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. If any drug related adverse event occurred, the dosage will be reduced.
Receives: Drug: Sorafenib
Sorafenib plus TACEExperimentalPatients in this arm will take Sorafenib orally with the dose of 400mg bid on the third day after randomization till recurrence or the end of this trial. TACE will be performed on the fourth day after randomization. If any drug related adverse event occurred, the dosage will be reduced.
Receives: Drug: Sorafenib; Procedure: Transarterial chemoembolization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence-free survival

    Recurrence-free survival indicates the interval between randomization and tumor recurrence or death.[0-2 years] Longer RFS time indicates better prognosis.

    Measured: 2 years

Secondary outcomes (4)

  1. Overall survival

    Overall survival indicates the interval between randomization and death.[0-2years]Longer OS time indicates better prognosis.

    Measured: 2 years

  2. Time to recurrence

    Time to recurrence indicates the interval between randomization and tumor recurrence.[0-2years]Longer TTR time indicates better prognosis.

    Measured: 2 years

  3. Severe adverse events

    Incidence rate of severe adverse events. [0-100%]. lower rate indicates more safety of the treatment

    Measured: 2 years

  4. Quality of life

    Questionnaire score of EORTC-QOL. Higher score indicates better quality of life

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start15 Sep 2019
  3. Primary completion15 Sep 2021 (estimated)
  4. Study completion15 Sep 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
158 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04143191
Sponsor's protocol ID
FAH-20190358
Acronym
SOURCE
Status last verified
Mar 2020
First submitted
26 Oct 2019
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peng Z, Fan W, Liu Z, Xiao H, Wu J, Tang R, Tu J, Qiao L, Huang F, Xie W, Zhuang W, Guo W, Li S, Hua Y, Shen S, He Q, Li D, Li J, Kuang M. Adjuvant Transarterial Chemoembolization With Sorafenib for Portal Vein Tumor Thrombus: A Randomized Clinical Trial. JAMA Surg. 2024 Jun 1;159(6):616-624. doi: 10.1001/jamasurg.2024.0506.

    PubMed 38568599

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib and Transarterial chemoembolization in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ming Kuang, MD, PhD. (008687755766 ext. 8576, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04143191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.

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