Adjuvant Entecavir or Tenofovir for Postoperative HBV-HCC
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|ClinicalTrials.gov Identifier: NCT02650271|
Recruitment Status : Recruiting
First Posted : January 8, 2016
Last Update Posted : January 18, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Entecavir Drug: Tenofovir||Phase 3|
Hepatocellular carcinoma (HCC) is associated with a poor prognosis, and its incidence has increased dramatically in many countries. Hepatectomy is a radical therapy for early-stage HCC. However, even after radical resection, the prognosis for HCC patients remains discouraging because of the high recurrence rate and frequent incidence of intrahepatic metastasis. Therefore, preventing HCC recurrence is very important.
Hepatitis B virus (HBV) infection is the major risk factor for HCC development in China. Some retrospective studies have shown that tenofovir or entecavir treatment for HBV-related HCC patients can effectively reduce the HCC recurrence rate and increase the survival rate after hepatectomy. However, which drug has more efficacy has not been addressed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Adjuvant Entecavir or Tenofovir for Hepatitis B Virus Related Hepatocellular Carcinoma After Curative Hepatic Resection|
|Actual Study Start Date :||February 2, 2021|
|Estimated Primary Completion Date :||December 25, 2022|
|Estimated Study Completion Date :||December 30, 2022|
Patients will be received entecavir (10 mg/d) after 3 days of liver resection.
Patients will be received entecavir (10 mg/d) before liver resection.
Other Name: ETV
Active Comparator: Tenofovir
Patients will be received tenofovir (1#/d) after 3 days of liver resection.
Patients will be received tenofovir before liver resection.
- overall survival [ Time Frame: 1-year ]
- Recurrence rate [ Time Frame: 1-year ]
- Perioperative reactivation of hepatitis B virus replication [ Time Frame: 1-month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650271
|Contact: Jian-Hong Zhong, MDfirstname.lastname@example.org|
|Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University||Recruiting|
|Nanning, Guangxi, China, 530021|
|Contact: Jian-Hong Zhong, MD email@example.com|