The Role of Low Molecular Weight Heparins (LMWH) Combined With Transarterial Chemoembolization (TACE) in Hepatocellular Carcinoma
Information source: Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatocellular Carcinoma
Intervention: LMWH (Drug); TACE (Procedure)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Eastern Hepatobiliary Surgery Hospital Official(s) and/or principal investigator(s): Shen Feng, MD, Study Chair, Affiliation: Eastern Hepatobiliary Surgery Hospital
Overall contact: Kan Tong, MD, Phone: 86-21-81870774, Email: kanto168.888@vip.163.com
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.
Clinical Details
Official title: A Clinical Randomized Control Trial of Combination TACE With and Without Low-Molecular-Weight Heparin in Hepatocellular Carcinoma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: time-to-progression(TTP)
Secondary outcome: The overall response rateOverall survival (OS) bleeding complication rate Progression Free Survival (PFS)
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
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Kan Tong, MD, Phone: 86-21-81870774, Email: kanto168.888@vip.163.com
Eastern Hepatobiliary Surgery Hospital, ShangHai, Shanghai 200438, China; Recruiting Kan Tong, MD, Phone: 86-21-81870774, Email: kanto168.888@vip.163.com Yang Jia-mei, MD, Phone: 86-21-81870808, Email: Yang-jia-mei@163.com Kan Tong, MD, Principal Investigator
Additional Information
Starting date: December 2008
Last updated: January 21, 2009
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