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Hepatocellular CarcinomaPhase 3SELECTNCT01906216

Sorafenib Chemoembolization Evaluation Controlled Trial

A Phase 3 study testing Sorafenib and TACE in people with Hepatocellular Carcinoma, run by Air Force Military Medical University, China 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

This prospective, multicenter, randomized, controlled study aims to evaluate the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) in advanced hepatocellular carcinoma (HCC) patients compared with sorafenib alone, and to determine the prognostic factors that influence the survival. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Sorafenib and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
1 siteChina
Study dates
Sep 2013to 30 Jun 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Prior informed consent
  • Advanced stage HCC/ Barcelona Clinic Liver Cancer(BCLC) C stage
  • Confirmed Diagnosis of HCC:
  • Cirrhotic subjects: Clinical diagnosis by Asian Pacific Association for the Study of the Liver(AASLD) criteria.
  • Non-cirrhotic subjects: for subjects without cirrhosis, histological or cytological confirmation is mandatory
  • Documentation of original biopsy for diagnosis is acceptable
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  • Child Pugh class A without ascites or hepatic encephalopathy
  • Eastern Cooperative Oncology Group(ECOG) Performance Status of 0-1
  • At least one uni-dimensional lesion measurable by CT-scan or MRI according to the RECIST, mRECIST and EASL criteria,respectively
  • single lesion>5cm
  • 2-3 lesions, at least one lesion>3cm if more than 4 lesions, no limitation of the tumor size, but the sum of size of all tumor lesions should be less than 50% of liver parenchyma.
  • Male or female subjects ≥ 18 years of age
  • Ability to swallow oral medications
  • Life expectancy of at least 12 weeks
  • Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
  • Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 7 days prior to randomization:
  • Hemoglobin > 9.0 g/dl
  • Absolute neutrophil count (ANC) >1,500/mm3
  • Platelet count≥50x109/L
  • ALB≥28g/L
  • Total bilirubin < 2 mg/dL
  • Alanine aminotransferase(ALT) and aspartate aminotransferase(AST) < 5 x upper limit of normal
  • Blood urea nitrogen(BUN) and creatinine < 1.5 x upper limit of normal
  • International normalized ratio(INR) < 1.7, or prothrombin time（PT） < 4 seconds above control

Who cannot join

  • Diffuse HCC or tumor burden ≥50% of liver parenchyma
  • Main portal vein obstruction, vascular invasion in hepatic vein or inferior vena cava
  • Presence of metastasis in biliary tract,brain or bone
  • Poor blood supply for the liver tumor lesions; poor blood supply refers that the tumor lesions fail to show obvious contrast uptake in the arterial phase and washout in venous or late phases by CT scan or MRI
  • Any contraindications for hepatic embolization procedures:
  • Known hepatofugal blood flow
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  • Known porto-systemic shunt
  • Renal failure / insufficiency requiring hemo-or peritoneal dialysis
  • Target lesions having previously been treated with local therapy such as resection of HCC, radiofrequency ablation (RFA), percutaneous ethanol injection (PEI)
  • Other molecular target drugs ongoing or completed < 4 weeks prior to the baseline scan
  • Prior transarterial embolization or systemic chemotherapy
  • Any ≥ CTC adverse events(AEs) grade 2 acute toxic effects of any prior local treatment
  • Patients with untreated varices or active bleeding
  • History of cardiac disease:
  • Congestive heart failure >New York Heart Association (NYHA) class 2
  • Uncontrolled hypertension
  • Known history of HIV infection
  • Active clinically serious infections (> grade 2 NCI-CTCAE Version 3.0), except for Hepatitis B virus(HBV) and hepatitis C virus(HCV) infection
  • Clinically significant gastrointestinal bleeding within 4 weeks prior to start of study drug
  • Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug
  • Previous or concurrent cancer that is distinct in primary site or histology from HCC. Any cancer curatively treated >3 years prior to entry is permitted
  • Any contraindication for sorafenib or doxorubicin administration
  • Pregnant or breast-feeding subjects
  • Any disease(within 6 months of randomization)which could affect the evaluation of the study drug
  • Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
  • Major surgery within 4 weeks prior to start of study drug (e.g. thoracolaparotomy is not allowed, but noninvasive surgery, e.g. biopsy, is allowed)
  • Autologous bone marrow transplant or stem cell rescue within 1 year prior to start of study drug
  • History of organ allograft

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xijing Hospital of Digestive Disease

    Xi'an, Shaanxi, 710032

Other trials in China

About this study

Official title: Sorafenib With or Without Transarterial Chemoembolization (TACE) in Advanced Hepatocellular Carcinoma : A Multicenter, Randomized, Controlled Trial

This prospective, multicenter, randomized, controlled study aims to evaluate the efficacy and safety of sorafenib combined with transarterial chemoembolization (TACE) in advanced hepatocellular carcinoma (HCC) patients compared with sorafenib alone, and to determine the prognostic factors that influence the survival.

Data on the efficacy and safety of sorafenib in combination with TACE in patients with advanced HCC are lacking. Because in western countries, advanced HCC is considered as a contraindication for TACE treatment. However, clinical practice patterns differ markedly between Asia and western countries: in Asia TACE is performed in selected advanced HCC patients. We consider sorafenib combined with TACE could achieve better survival benefit than sorafenib alone in selected advanced HCC patients.

Read the detailed description

PRIMARY OBJECTIVE:

To compare the overall survival of selected advanced HCC patients treated with sorafenib combined with TACE with sorafenib alone.

SECONDARY OBJECTIVES:

  1. To compare the time to progression (TTP, according to mRECIST criteria).
  2. To compare the tumor response and disease control rate according to Response Evaluation Criteria in Solid Tumors (RECIST1.1), modified Response Evaluation Criteria in Solid Tumors (mRECIST) and European Association of Liver Disease (EASL) criteria.
  3. To compare the safety.

OTHER OBJECTIVES:

  1. To explore the prognostic value of AFP response after treatment.

OUTLINE: This is a multicenter, phase 3, prospective, randomized, controlled trial. Patients are stratified according to

  1. ECOG ( 0 vs. 1)
  2. Tumor burden
  3. single vs. multiple lesions
  4. tumor size (>8cm vs. ≤8cm)
  5. vascular invasion (yes vs. no)
  6. extrahepatic metastasis (yes vs. no)
  7. Alpha fetoprotein(AFP)(≤ 200 ng/mL vs. > 200 ng/mL) Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening). Patients undergo the first conventional transarterial chemoembolization (TACE) within 3-7 days after the first administration of sorafenib. The conventional TACE consists of an injection containing a mixture of chemotherapeutic agents (doxorubicin) and lipiodol followed by embolization with polyvinyl alcohol (PVA) or beads until complete stasis was achieved in the tumor-feeding vessels. Tumor-feeding vessels should be selected/superselected whenever possible. TACE will be repeated "on demand" depending on the radiological response.

ARM II: Patients receive two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening).

MAINTENANCE THERAPY: Standard follow-up evaluations include contrast-enhanced CT scan and laboratory assessment. Laboratory assessment will be performed every 4 weeks. Radiological follow-up (contrast-enhanced CT scan in liver and chest X-ray) will be performed during week 4 and week 8 after initiation of treatment and thereafter every 8 weeks.

Being tested
Sorafenib, TACE
Keywords
Hepatocellular carcinoma, 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

    Also called Bay 43-9006, Sorafenib (Nexavar®)

    Sorafenib will be supplied as 200 mg tablets. All subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening).

  • TACEProcedure or surgery

    The first treatment of TACE should be completed within 3-7 days after the administration of sorafenib started. In all cases, TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) or beads until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible. TACE will be repeated "on demand" depending on the radiological response.

Study groups in NCT01906216
Study groupRoleWhat they receive
SorafenibActive comparatorAll subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening). Sorafenib may be taken either with a low/moderate fat meal or without food. Subjects are to continue sorafenib according to the study protocol if the adverse events could be safely controlled.
Receives: Drug: Sorafenib
Sorafenib combined with TACEExperimentalSorafenib will be supplied as 200 mg tablets. All subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening). In addition, the subjects in this arm will receive the treatment of conventional transarterial chemoembolization. In all cases, TACE consists of an injection containing a mixture of chemotherapeutic agents(doxorubicin) and lipiodol followed by embolization with polyvinyl alcohol (PVA) or beads.
Receives: Drug: Sorafenib; Procedure: TACE

What is being measured

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

  1. Overall survival

    Overall survival (OS) analysis is measured from the time of randomization until death occurred from any cause.

    Measured: The final analysis will occur when the expected number of death (173 events) is reached. Up to 2.5 years

Secondary outcomes (3)

  1. Time to progression

    The time to progression is measured from the time of randomization to the radiologically confirmed progression according to mRECIST criteria.

    Measured: The time to progression will be assessed at the end of the study, up to 2.5 years

  2. Tumor response

    Tumor response will be evaluated according to RECIST, mRECIST and EASL criteria, respectively. Tumor response will be presented in the terms of complete response, partial response, stable disease and progression disease.

    Measured: Tumor response will be assessed up to 2.5 years

  3. Adverse events

    The terms and grade of adverse events will be presented according to the Common Terminology Criteria for Adverse Events(CTCAE:version 4.0)

    Measured: The adverse events will be assessed up to 2.5 years.

Timeline

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

  1. First posted24 Jul 2013 (estimated)
  2. Study startSep 2013
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

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
Single blind
Who is masked
Outcomes assessor
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01906216
Sponsor's protocol ID
XHDD-001
Acronym
SELECT
Status last verified
Aug 2024
First submitted
29 May 2013
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No

Publications

  • Zhao Y, Wang WJ, Guan S, Li HL, Xu RC, Wu JB, Liu JS, Li HP, Bai W, Yin ZX, Fan DM, Zhang ZL, Han GH. Sorafenib combined with transarterial chemoembolization for the treatment of advanced hepatocellular carcinoma: a large-scale multicenter study of 222 patients. Ann Oncol. 2013 Jul;24(7):1786-1792. doi: 10.1093/annonc/mdt072. Epub 2013 Mar 18.

    PubMed 23508822

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib and TACE in people with Hepatocellular Carcinoma, run by Air Force Military Medical University, China 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 24 inclusion and 28 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 Aug 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: The final analysis will occur when the expected number of death (173 events) is reached. Up to 2.5 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 NCT01906216, 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 Aug 2024; AzTrials last refreshed its copy on 31 Oct 2026.

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