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Hepatocellular CarcinomaPhase 3TREATNCT04103398

TACE Plus Sorafenib Versus TACE Alone for Recurrent Intermediate Hepatocellular Carcinoma

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

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
TACE+sorafenib and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteChina
Study dates
2 Oct 2019to 31 Dec 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

  • Age: 18-75 years;
  • Diagnosed as HCC based on the American Association for the Study of Liver Diseases 2018 Guideline on Liver Cancer Diagnosis;
  • 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;
  • Histologically confirmed microvascular invasion in the specimen slices of surgically removed primary tumor;
  • Eastern Cooperative Oncology Group scoring 0-1;
  • Child-Pugh A class;
  • At least 3 months of life expectancy;
  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080

Other trials in China

About this study

Official title: TRansarterial ChEmoembolization Plus SorAfenib Versus Transarterial Chemoembolization Alone for Recurrent Intermediate Hepatocellular Carcinoma: A Phase 3, Open Label, Multicenter, Randomized Controlled Trial

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.

Being tested
TACE+sorafenib, TACE
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • TACE+sorafenibCombination product

    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.

  • TACEProcedure or surgery

    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.

Study groups in NCT04103398
Study groupRoleWhat they receive
Transarterial chemoembolization combined with sorafenibExperimentalThe 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.
Receives: Combination Product: TACE+sorafenib
Transarterial chemoembolization aloneActive comparatorEither 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.
Receives: Procedure: TACE

What is being measured

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

  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.

    Measured: 2 years

Secondary outcomes (6)

  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.

    Measured: 2 years

  2. Time To Progression

    Defined as the time from randomization until disease progression.

    Measured: 2 years

  3. Objective Response Rate

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

    Measured: 2 years

  4. Disease Control Rate

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

    Measured: 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).

    Measured: 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).

    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 posted25 Sep 2019
  2. Study start2 Oct 2019
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2023

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04103398
Sponsor's protocol ID
20190921
Acronym
TREAT
Status last verified
Feb 2024
First submitted
20 Sep 2019
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Fan W, Zhu B, Chen S, Wu Y, Zhao X, Qiao L, Huang Z, Tang R, Chen J, Lau WY, Chen M, Li J, Kuang M, Peng Z. Survival in Patients With Recurrent Intermediate-Stage Hepatocellular Carcinoma: Sorafenib Plus TACE vs TACE Alone Randomized Clinical Trial. JAMA Oncol. 2024 Aug 1;10(8):1047-1054. doi: 10.1001/jamaoncol.2024.1831.

    PubMed 38900435

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TACE+sorafenib and TACE in people with Hepatocellular Carcinoma and Sorafenib, 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 8 inclusion and 14 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall 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 NCT04103398, 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 28 Feb 2024.

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