Status:
UNKNOWN
Chemoembolization With or Without Antiviral Therapy for Unresectable HBV-related HCC With Low HBV DNA Replication
Lead Sponsor:
Sun Yat-sen University
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Although it is commonly accepted that antiviral therapy should be commenced before or during hepatocellular carcinoma (HCC) treatment if the patients have high viral loads and elevated ALT or total bi...
Detailed Description
In highly endemic areas, hepatitis B virus (HBV) infection plays a primary role in the etiology of HCC and is frequently observed in HCC patients. Patients with HBV-related HCC usually have a history ...
Eligibility Criteria
Inclusion
- Male or female patients from 18 to 75 years of age with a diagnosis of HCC. A diagnosis of HCC based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).
- The patient has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation, or any other treatment with chemotherapeutic agents or sorafenib.
- The patient has not been previously treated with any anti-viral agents, including interferon or nucleosides analogs (NAs).
- Adults patients with a diagnosis of HCC which is not amenable to surgical resection ,local ablative therapy or any other radically cured treatment.
- The MDT group of HCC agree to administer TACE in this patient.
- Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
- No serious concurrent medical illness.
- Unresectable TNM stage Ⅲ or Ⅳ disease.
- Zubrod-ECOG-WHO performance status: 0 or 1. and the estimated survival more than 4 months.
- Not pregnant or breast-feeding patients
- 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
- Ability to understand the protocol and to agree to and sign a written informed consent document
- The following laboratory parameters at baseline:
- Platelet count ≥ 70,000/µL
- Hemoglobin ≥ 8.5 g/dL
- Absolute neutrophil count (ANC) \>1,500/mm3
- Total bilirubin ≤ 1.5 mg/dL Serum albumin ≥ 35 g/L
- Serum creatinine ≤ 1.5 x upper limit of normal
- PT prolong time less than 3 seconds
- Cirrhotic status of Child-Pugh class A only
- ALT\<2×upper limit of normal
- Hepatitis B surface antigen positive
- If hepatitis B e antigen positive, HBV DNA level \<2000IU/mL; If hepatitis B e antigen negative, HBV-DNA\<200IU/mL.
Exclusion
- \- History of HIV or HCV infection.
- History of organ allograft
- Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- Evidence of bleeding diathesis.
- Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of study entry.
- Serious non-healing wound, ulcer, or bone fracture
- Known central nervous system tumors including metastatic brain disease
- Any event \> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0
- Severe complication after TACE.
- History of hepatotoxic medication within 8 wk prior to the current treatment.
- History of corticosteroid administration.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01894269
Start Date
July 1 2013
End Date
July 1 2016
Last Update
July 23 2013
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060