Clinical trial NCT00827554: The Role of Low Molecular Weight Heparins in Hepatocellular Carcinoma
Official title: A Clinical Randomized Control Trial of Combination TACE With and Without Low-molecular-weight Heparin in Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hepatocellular Carcinoma
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
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: time-to-progression(TTP)
timeFrame: 1 year
Secondary outcomes:
measure: The overall response rate
timeFrame: 1 year
measure: Overall survival (OS)
timeFrame: 1 year
measure: bleeding complication rate
timeFrame: 6 weeks
measure: Progression Free Survival (PFS)
timeFrame: 1 year
Other outcomes:
Locations:
city: ShangHai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital
name: Shen Feng, MD
role: STUDY_CHAIR
References: