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Hepatocellular CarcinomaNCT02529761

TACE With or Without Sorafenib in Intermediate Stage Hepatocellular Carcinoma

A study testing Sorafenib and TACE in people with Hepatocellular Carcinoma, run by Air Force Military Medical University, China 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 The sponsor has not verified this record for over two years, so it may be out of date.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 multicenter prospective nonrandomized study is to evaluate the efficacy of TACE combined with sorafenib compared with TACE monotherapy in term of overall survival in intermediate-stage HCC. 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
330 participants
Where
1 siteChina
Study dates
Aug 2015to Oct 2021
Phase
Interventional
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
  • Intermediate stage HCC/ BCLC B stage
  • Confirmed Diagnosis of HCC:
  • Cirrhotic subjects: Clinical diagnosis by AASLD criteria. HCC can be defined in cirrhotic subjects by one imaging technique (CT scan, MRI, or second generation contrast ultrasound) showing a nodule larger than 2 cm with contrast uptake in the arterial phase and washout in venous or late phases or two imaging techniques showing this radiological behavior for nodules of 1-2 cm in diameter. Cytohistological confirmation is required for subjects who do not fulfill these eligibility criteria.
  • Non-cirrhotic subjects: For subjects without cirrhosis, histological or cytological confirmation is mandatory. Documentation of original biopsy for diagnosis is acceptable
  • Child Pugh class A/B(7) class without ascites or hepatic encephalopathy
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  • ECOG Performance Status of 0-1
  • At least one uni-dimensional lesion measurable by CT-scan or MRI according to the RECIST 1.1, 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 subject ≥ 18 years of age
  • Ability to swallow oral medications
  • Life expectancy of at least 12 weeks
  • Pregnancy test negative within 14 days before treatment. 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 functions 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
  • ALT and AST < 5 x upper limit of normal
  • BUN and creatinine < 1.5 x upper limit of normal
  • INR < 1.7, or PT < 4 seconds above control

Who cannot join

  • Diffuse HCC or tumor size ≥50% of liver parenchyma
  • Vascular invasion
  • Presence of extrahepatic metastasis
  • 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)
  • Investigational drugs or other molecular target drugs ongoing or completed < 4 weeks prior to the baseline scan
  • Prior transarterial embolization or anti-tumor systemic chemotherapy
  • Any ≥ CTC AE 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 4.0), except for HBV and 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 which could affect the evaluation of the study drug: unstable angina, active CAD, uncontrolled arrhythmias, and myocardial infarction
  • 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.

Guohong Han, MD contact

+862984771528

guohhan@126.com

Wei Bai, MD contact

chris41532@163.com

China1 site, 1 recruiting

  • Xijing Hospital of digestive disease, Fourth Military Medical University

    Xi'an, Shaanxi, 710032

    Han, hangh@fmmu.edu.cn

    Guohong Han, MD,Ph.D

    Recruiting

Other trials in China

About this study

Official title: Transarterial Chemoembolization (TACE) With or Without Sorafenib in Intermediate Stage Hepatocellular Carcinoma: a Multicenter Prospective Nonrandomized Study

This multicenter prospective nonrandomized study is to evaluate the efficacy of TACE combined with sorafenib compared with TACE monotherapy in term of overall survival in intermediate-stage HCC.

Read the detailed description

Sorafenib, a multikinase inhibitor, has been successfully applied for solid tumors such as renal cancer and HCC.

According to the Barcelona Clinic Liver Cancer (BCLC) staging classification, transarterial chemoembolization (TACE) has been recommended as a first line-therapy for patients at intermediate stage - BCLC B class (multinodular asymptomatic tumors without an invasive pattern).

Because sorafenib may improve the efficacy of locoregional therapy by decreasing post-TACE angiogenesis, sorafenib in combination with TACE has attracted considerable attention as a promising therapy

Being tested
Sorafenib, TACE
Keywords
HCC, sorafenib, TACE, overall survival
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

    Also called conventional transarterial chemeombolization

    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) particles 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 NCT02529761
Study groupRoleWhat they receive
Sorafenib combined with TACEExperimental220 subjects in this study group will receive the treatment of sorafenib combined with conventional TACE.
Receives: Drug: Sorafenib; Procedure: TACE
TACE monotherapyActive comparator110 subjects in this study group will receive the treatment of conventional TACE monotherapy.
Receives: Procedure: TACE

What is being measured

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

  1. Overall survival

    Overall survival analysis is measured from the treatment start until death occurred from any cause

    Measured: The last patient has been on study for 1.5 year

Secondary outcomes (4)

  1. Time to progression

    The time to progression is measured from the treatment start to the radiologically confirmed progression

    Measured: The time to progression will be assessed at the end of the study, up to 3 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 at week 4 and week 8 after initiation of treatment and thereafter every 8 weeks (±7 days), up to 3 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 every 4 weeks, up to 3 years

  4. Prognostic factor

    The Cox proportional model will be used to assess the prognostic factors

    Measured: The analysis will be perfomed when the last patient has been on study for 1.5 year

Timeline

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

  1. First posted20 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionAug 2021 (estimated)
  4. Study completionOct 2021 (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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02529761
Sponsor's protocol ID
S-T 002
Status last verified
Aug 2019
First submitted
18 Aug 2015
Last updated
1 Aug 2019
Results posted
No
Data monitoring committee
No

Publications

  • European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.

    PubMed 22424438

  • 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 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 23 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: status not confirmed, as of the sponsor's last update on 1 Aug 2019. 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.

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 Guohong Han, MD (+862984771528, guohhan@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: The last patient has been on study for 1.5 year). 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 NCT02529761, which also lists 2 linked publications.

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 1 Aug 2019.

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