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AzTrials

Hepatocellular CarcinomaPhase 3NCT01833299

Transcatheter Arterial Chemoembolization Combined With Sorafenib for Unresectable Hepatocellular Carcinoma

A Phase 3 study testing TACE-Sorafenib group and TACE in people with Hepatocellular Carcinoma and Face Cancer, 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

Hepatocellular carcinoma (HCC) is the 6th most common cancer and the third most frequent cause of cancer death worldwide. Hepatic resection (HR) has been the standard treatment modality for HCC aiming at clinical cure. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma, Face Cancer
What is being tested?
TACE-Sorafenib group and TACE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteChina
Study dates
Jan 2010to Dec 2018
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

  • Adults patients ( 18-75 years of age) with a diagnosis of HCC which is not amenable to surgical resection or local ablative therapy
  • Histological confirmed HCC or clinical/laboratory diagnosis of HCC or nodules larger than 2 cm with typical vascular features or AFP > 200
  • Patient must have quantifiable disease limited to the liver
  • Patients must have at least one tumor lesion that meets both of the following criteria:
  • The lesion can be accurately measured in at least one dimension according to RECIST criteria
  • The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
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  • ECOG performance status (PS) <2
  • No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy,At least 4 weeks since prior TACE, At least 4 weeks since prior interferon.
  • Not pregnant
  • No significant baseline liver dysfunction. Cirrhotic status of Child-Pugh class A only
  • No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
  • No current infections requiring antibiotic therapy
  • Not on anticoagulation or suffering from a known bleeding disorder
  • No unstable coronary artery disease or recent MI

Who cannot join

  • Previous or concurrent cancer that is distinct in primary site or histology from HCC except cervical carcinoma in situ, treated basal-cell carcinoma of the skin, superficial bladder tumors (Ta, Tis \& T1), and any cancer curatively treated > 3 years prior to entry is permitted
  • Renal failure requiring hemo- or peritoneal dialysis
  • Child-Pugh B \& C hepatic impairment
  • History of cardiac disease: > NY Heart Association (NYHA) class 2 congestive heart failure, active coronary artery disease, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, and uncontrolled hypertension. Myocardial infarction more than 6 months prior to study entry is permitted.
  • Active clinically serious infections (> CTCAEv3 grade 2)
  • Known history of HIV
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  • Known central nervous system tumors including metastatic brain disease
  • History of organ allograft
  • Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • Known or suspected allergy to the investigational agents or any agent given in association with this trial.
  • Patients unable to swallow oral medications.
  • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of the study drug. Both men and women enrolled in this trial must use adequate barrier birth control measures during the course of the trial.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 90 mmHg, despite optimal medical management
  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
  • Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
  • Serious non-healing wound, ulcer, or bone fracture

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Centre of Sun Yat-Sen University

    Guangzhou, 510060

Other trials in China

About this study

Hepatocellular carcinoma (HCC) is the 6th most common cancer and the third most frequent cause of cancer death worldwide. Hepatic resection (HR) has been the standard treatment modality for HCC aiming at clinical cure. In both Europe and Unit States proposed guidelines for HCC, HR was recommend only for patients with a single HCC lesion and preserved liver function . Unfortunately, only 10%-30% of HCCs are amenable to such "curative" surgical resection at the time of diagnosis, because of tumor multifocality, portal vein invasion, and underlying advanced liver cirrhosis . Alternatively, transarterial chemoembolization (TACE) has become the most popular modality for palliative treatment for the other patients. However, the long term outcomes were generally poor for HCC patients treated with TACE.

Recently, sorafenib has shown some promises in improvement of 3-month survival among patients with advanced HCC. It is claimed that sorafenib has become the standard of care for patients advanced HCC.

Thus, the purpose of this study was to prospectively compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC .

Read the detailed description

Hepatocellular carcinoma (HCC) is a common cause of cancer mortality in Asia. Most patients present with intermediate or advanced disease. Percutaneous ethanol injection, radiofrequency ablation, and transcatheter arterial chemoembolization (TACE) are not considered as a curative treatment and have achieved very limited success in eradicating large HCC.

Two phase III trials were shown to be efficacious and well-tolerated in patients with advanced HCC. Median overall survival was significantly 2 to 3 months longer in the sorafenib group than that in the placebo. It is interesting to recognize the combined therapeutic effect of TACE with sorafenib. The proposed study will make an important contribution to understanding not only the safety and efficacy of sorafenib in addition to TACE in patients diagnosed with unresectable HCC, but this will also be the first clinical trial prospectively to compare the effectiveness of sorafenib combined with TACE with that of TACE alone in the treatment of unresectable HCC

Being tested
TACE-Sorafenib group, TACE
Keywords
TACE, Sorafenib, overall survival, time to progression
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-Sorafenib groupProcedure or surgery

    Also called TACE combined with Sorafenib

    Transcatheter arterial chemoembolization drugs and dosage:TACE with chemothrapy drugs (E-ADM 50mg, carboplatin 300 mg, MMC 8mg)and followed with embolization with lipiodol and absorbable gelatin sponge particles or polyvinyl alcohol particles.

    Oral sorafenib (400 mg BID) will be start the 2-4 weeks after the first TACE treatment and will continue until the patient shows disease progression, until unacceptable toxicity occurs, or until study termination.

  • TACEProcedure or surgery

Study groups in NCT01833299
Study groupRoleWhat they receive
TACE groupActive comparatorTranscatheter arterial chemoembolization drugs and dosage:TACE with chemothrapy drugs (E-ADM 50mg, carboplatin 300 mg, MMC 8mg)and followed with embolization with lipiodol and absorbable gelatin sponge particles or polyvinyl alcohol particles.
Receives: Procedure: TACE
TACE+sorafinibExperimentalTACE+sorafinib
Receives: Procedure: TACE-Sorafenib group

What is being measured

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

  1. Effectiveness of sorafenib combined with TACE

    Measure:overall survival Measured from the date of TACE until the date of death or last visit

    Measured: 1 year

Secondary outcomes (1)

  1. Time to progression

    Measured: 1 year

Timeline

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

  1. First posted16 Apr 2013 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2016
  4. Study completionDec 2018

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01833299
Sponsor's protocol ID
TACE-Sorafenib
Status last verified
Feb 2020
First submitted
13 Apr 2011
Last updated
11 Feb 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • Parkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin 2005;55:74-108. Llovet JM, Real MI, Montan˜a X, et al. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002;359:1734-59. Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359:378-90. Bruix J, Llovet JM. Major achievements in hepatocellular carcinoma. Lancet 2009 21;373:614-616.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TACE-Sorafenib group and TACE in people with Hepatocellular Carcinoma and Face Cancer, 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 14 inclusion and 18 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 11 Feb 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?

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?

Effectiveness of sorafenib combined with TACE (time frame: 1 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 NCT01833299, 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 11 Feb 2020.

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