Chemoembolization With or Without Antiviral Therapy for Unresectable HBV-related HCC With Low HBV DNA Replication

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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 bilirubin values with signs of cirrhosis, the dilemma exists when HBV DNA and liver function (such as ALT, AST, TBIL) remains low level. Whether antiviral therapy make sense or not in these patients with no signs of hepatitis or high viral replication remains unclear, especially for the relatively advanced stage HCC patients receiving TACE. Thus, the investigators carried out this prospective control study to compare the survivals for patients after TACE between with or without antiviral therapy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Antiviral Agents; Entecavir; Lamivudine

Criteria

Inclusion Criteria:

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 Criteria:

• 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.