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Hepatocellular CarcinomaPhase 2/3NCT00827554

The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma

A Phase 2/3 study testing LMWH and TACE in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital 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 a major tumor type worldwide, especially in China as the sequence of hepatitis B and liver cirrhosis. Activation of the coagulation system occurs commonly in patients with malignancy. 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?
LMWH and TACE
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
Dec 2008to Oct 2011
Phase
Phase 2/3
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 with a diagnosis of HCC which is not amenable to surgical resection, liver transplantation or local ablative therapy
  • Without metastasis out of 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.
  • ECOG performance status (PS) <2
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  • No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At least 4 weeks since prior systemic chemotherapy
  • Child-Pugh class A or B
  • No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on dialysis
  • Ability to understand the protocol and to agree to and sign a written informed consent document -

Who cannot join

  • HBSAg(-)，AFP(-).
  • prothrombin time prolonged more than 4s.
  • blood platelets count less than 50000/L.
  • Renal failure requiring dialysis.
  • Child-Pugh class C hepatic impairment.
  • clinically significant gastrointestinal bleeding within 30 days prior to study entry.
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  • 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.
  • Pregnant or breast-feeding patients.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Eastern Hepatobiliary Surgery Hospital

    Shanghai, Shanghai Municipality, 200438

Other trials in China

About this study

Official title: A Clinical Randomized Control Trial of Combination TACE With and Without Low-molecular-weight Heparin in Hepatocellular Carcinoma

Hepatocellular carcinoma (HCC) is a major tumor type worldwide, especially in China as the sequence of hepatitis B and liver cirrhosis. Activation of the coagulation system occurs commonly in patients with malignancy. Several studies have suggested that anticoagulant therapy may improve survival in patients with malignancy. The low molecular weight heparins (LMWHs) lend themselves to such studies because of their effects in experimental models of malignancy and the relative ease of administration compared with unfractionated heparin. The purpose of the present RCT was to determine whether addition of LMWH to transarterial chemoembolization (TACE) would improve HCC patient outcome compared with TACE alone.

Read the detailed description

100 patients will be randomly assigned to receive either TACE alone or TACE plus LMWH. A block of every 4 participants and a stratified randomization according to portal vein cancer emboli will be used to restrict randomization. LMWH consisted of nadroparin Ca will be given at a dose of 4100 U twice daily during 6 weeks after TACE. The time to progression(TTP) and overall survival within two years will be used to evaluate the effect of LMWH on HCC.

Being tested
LMWH, TACE
Keywords
Liver Neoplasms, Liver Diseases, Digestive System Diseases, Digestive System Neoplasms, Carcinoma, Hepatocellular, Gastrointestinal Neoplasms, Adenocarcinoma, Hepatocellular carcinoma, Neoplasms, Transarterial chemoembolization, Nadroparin, low-molecular-weight heparin, chemoembolization
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms, Liver Diseases, Digestive System Diseases, Digestive System Neoplasms, Gastrointestinal Neoplasms, Adenocarcinoma, Neoplasms

What participants receive

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

  • LMWHDrug

    Also called fraxiparine, GlaxoSmithKline

    Nadroparin Ca 4100 AXa iu twice daily lasted for 6 weeks

  • TACEProcedure or surgery

    Also called transarterial embolization/chemoembolization

    transarterial chemoembolization with lipiodol 1-1.5ml/cm tumor diametres，pharmorubicin 20mg，5-Fu 1g and Carboplatin 150mg。

Study groups in NCT00827554
Study groupRoleWhat they receive
LMWH plus TACEExperimental50 HCC patients will be allocated to receive Nadroparin 4100 AXa iu twice daily 3 days after TACE which lasted for 6 weeks
Receives: Drug: LMWH; Procedure: TACE
TACE aloneActive comparator50 HCC patients randomly assigned to receive TACE without LMWH
Receives: Drug: LMWH; Procedure: TACE

What is being measured

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

  1. time-to-progression(TTP)

    Measured: 1 year

Secondary outcomes (4)

  1. The overall response rate

    Measured: 1 year

  2. Overall survival (OS)

    Measured: 1 year

  3. bleeding complication rate

    Measured: 6 weeks

  4. Progression Free Survival (PFS)

    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 posted22 Jan 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionAug 2011
  4. Study completionOct 2011

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00827554
Sponsor's protocol ID
EHBH-RCT-2008-011
Status last verified
Mar 2016
First submitted
21 Jan 2009
Last updated
1 Apr 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing LMWH and TACE in people with Hepatocellular Carcinoma, run by Eastern Hepatobiliary Surgery Hospital 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 10 inclusion and 10 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 1 Apr 2016. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

time-to-progression(TTP) (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 NCT00827554.

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 Apr 2016.

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