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A Clinical Randomized Control Trial of Combination TACE With and Without Low-Molecular-Weight Heparin in Hepatocellular Carcinoma


Phase 2/Phase 3
18 Years
75 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

A Clinical Randomized Control Trial of Combination TACE With and Without Low-Molecular-Weight Heparin in Hepatocellular Carcinoma


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.


Inclusion Criteria:



1. Adults patients with a diagnosis of HCC which is not amenable to surgical resection,
liver transplantation or local ablative therapy

2. Without metastasis out of liver

3. Patients must have at least one tumor lesion that meets both of the following
criteria:

1. The lesion can be accurately measured in at least one dimension according to
RECIST criteria

2. The lesion has not been previously treated with surgery, radiation therapy,
radiofrequency ablation, percutaneous ethanol or acetic acid injection, or
cryoablation.

4. ECOG performance status (PS) <2

5. No prior targeted antiangiogenic therapy. Metronomic chemotherapies are allowed. At
least 4 weeks since prior systemic chemotherapy

6. Child-Pugh class A or B

7. No significant renal impairment (creatinine clearance < 30 mL/minute) or patients on
dialysis

8. Ability to understand the protocol and to agree to and sign a written informed
consent document -

Exclusion Criteria:

1. HBSAg(-),AFP(-).

2. prothrombin time prolonged more than 4s.

3. blood platelets count less than 50000/L.

4. Renal failure requiring dialysis.

5. Child-Pugh class C hepatic impairment.

6. clinically significant gastrointestinal bleeding within 30 days prior to study entry.

7. History of organ allograft.

8. Substance abuse (current), psychological, or social conditions that may interfere
with the patient's participation in the study or evaluation of the study results.

9. Known or suspected allergy to the investigational agents or any agent given in
association with this trial.

10. Pregnant or breast-feeding patients.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

time-to-progression(TTP)

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Shen Feng, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Eastern Hepatobiliary Surgery Hospital

Authority:

China: Ministry of Health

Study ID:

EHBH-RCT-2008-011

NCT ID:

NCT00827554

Start Date:

December 2008

Completion Date:

January 2010

Related Keywords:

  • Hepatocellular Carcinoma
  • Liver Neoplasms
  • Liver Diseases
  • Digestive System Diseases
  • Digestive System Neoplasms
  • Carcinoma, Hepatocellular
  • Liver neoplasms
  • Gastrointestinal Neoplasms
  • Adenocarcinoma
  • Hepatocellular carcinoma
  • Neoplasms
  • Transarterial chemoembolization
  • Nadroparin
  • low-molecular-weight heparin
  • chemoembolization
  • Carcinoma
  • Carcinoma, Hepatocellular

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