HBV and Liver Cancer

NOTE: This section contains only hepatitis B-related liver cancer (HCC) clinical trials, for a complete list, please click here.

*CHB=Chronic hepatitis B, Liver cancer=hepatocellular carcinoma or HCC

 

A Study of Molecular Genetic Factors for Liver Cancer in the Greater Baltimore Area –U.S.
Patients between the age of 18 & 90 who have been diagnosed with HCC or have a high risk of developing HCC due to chronic hepatitis B or C. Contact: Dr. Dean L. Mann at 410-328-5512, dmann001@umaryland.edu or Dr. Xin Wang at 301-496-2099 or xw3u@nih.gov and refer to identifier – NCT00913757  (Study ID # 999909149, 09-C-N149)

Pembrolizumab (Keytruda) in Advanced Hepatocellular Carcinoma –U.S.
This is a phase II trial of Pembrolizumab (Keytruda) in patients with advanced, unresectable hepatocellular carcinoma. Contact Dr. Lynn Feun at 305-243-6606 or lfeun@med.miami.edu and refer to identifier NCT02658019. (Study ID # 20151049) 

Navitoclax and Sorafenib Tosylate in Treating Patients with Relapse or Refectory Solid Tumors – U.S.
This phase I trial studies the side effects and the best dose of navitoclax when given together with sorafenib tosylate in treating patients with solid tumors that have returned (relapsed) or do not respond to treatment (refractory). Navitoclas and sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. For study contact information in each state, region, or country, please go to the study’s description page and find the study location nearest you. The study’s sponsor is The National Cancer Institute (NCI). Refer to the study identifier – NCT02143401. (Study ID # NCI-2014-01043)

An Immuno-therapy Study to Evaluate the Effectiveness, Safety, and Tolerability of Nivolumab or Nivolumab in Combination With Other Agents in Patients with Advanced Liver Cancer (CheckMate040) – U.S. and International
This is a three phased study designed to establish the safety of nivolumab at different dose levels for each of the three cohorts (uninfected hepatocellular carcinoma (HCC), hepatitis C virus (HCV)-infected HCC subjects, and hepatitis B virus (HBV)-infected subjects), generate additional clinical data at specified doses for each of the 3 cohorts, and compare the efficacy of nivolumab and sorafenib in the treatment of Advanced HCC. For study contact information in each state, region, or country, please go to the study’s description page and find the study location nearest you. The study’s sponsor is Bristol-Myers Squibb. Refer to identifier NCT01658878. (Study ID # CA209-040, 2012-001514-42) 

A Study of Nivolumab Compared to Sorafenib as a Primary Treatment in Patients With Advanced Hepatocellular Carcinoma -- US and International
The purpose of this study is to determine if nivolumab or sorafenib is more effective in the treatment of Advanced Hepatocellular Carcinoma. For study contact information in each state, region or country, please go to the study’s description page and find the study location nearest you. The study’s sponsor is Bristol-Myers Squibb. Refer to the study identifier -- NCT02576509. (Study ID # CA209-459)

A Basic-clinical Translational Research in Hepatitis B Virus (HBV)-Specific Antigen Peptides and HepG2 Cell Lysate Co-activated Dendritic Cells Combined with Transarterial Chemoembolization (TACE) in HBV-related HCC Treatment (BTRHBVAPHCLCDCCTCHBVHCCT) - China
Researchers want to put forward a new scientific therapy called “Activated Dendritic-cells Combined Cyclophosphamide” (ADCC) combine with TACE for patients with advanced hepatocellular carcinoma to prolong their survival time. Contact: Yanling Huang at +8615626459901 or hyanlin3@mail2.sysu.edu.cn or Yuehua Huang at +8613318818899 and refer to identifier NCT03086564. (Study ID # huyangyuehuateam). 

Adjuvant Entecavir for Postoperative HBV-HCC -- China
This study aims to compare the effect of antiviral therapy with entecavir and lamivudine for hepatitis B virus-related liver cancer (hepatocellular carcinoma) after radical hepatectomy. Included patients will randomly divide into two groups. Contact Jian-Hong Zhong at zhongjianhong66@163.com or 86-771-5330855 and refer to identifier NCT02650271 (Study ID AEVT-HCC). 

Follow-up Strategy of Chronic Hepatitis B for Early Detection and Diagnosis of Hepatocellular Carcinoma: A Randomized Control Trial – China
The aim of this study is to establish an all-round and convenient follow-up strategy of CHB for early detection and diagnosis of Hepatocellular Carcinoma (HCC), by investigating whether different surveillance time intervals and surveillance methods are beneficial for chronic hepatitis B and cirrhotic patients with different risk of HCC. Contact: Zhongzhen Su at Sun Yat-Sen University at 0086-020-85252010 or sp9313@126.com and refer to identifier NCT02817685. (Study ID # SYSU2016)

Oral Vitamin D Treatment for the Prevention of Hepatocellular Carcinoma (VDHCC) – China (Not yet recruiting)
The purpose of this study is to determine whether vitamin D is effective in the prevention of hepatocellular carcinoma in those patients with chronic hepatitis B. Contact: Yutian Chong at ytchongkyzy@126.com and refer to identifier NCT02779465. (Study ID # SYSU-CYT-VD5010)

Study of Liver Resection With Versus Without Hepatic Inflow Occlusion for the HBV-related HCC (OHx-NOHx) – China
The study aims to compare the perioperative and long-term outcomes of liver resection for HBV-related HCC with versus without hepatic inflow occlusion. Contact Dr. Shichun Lu at +86 10 68160801 or sclu_301@163.com and refer to identifier NCT02563158. (Study ID # JFJZYY-GD-15-01)

TCR-Redirected T Cell Infusions to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation - China
This study plans to recruit 10 subjects with Hepatitis B virus (HBV) related HCC after liver transplantation. The objective of the study is to assess the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target population. Contact Dr. Lietao Li at (65) 6224 6157 or clinicaltrials@liontcr.com and refer to NCT02686372. (Study ID # LTCR-HCC-I-1)

TCR-Redirected T Cell Infusions to Treat Recurrent Hepatocellular Carcinoma Post Liver Transplantation - China
This study plans to recruit 10 patients with Hepatitis B virus (HBV) related HCC who underwent liver transplantation and are confirmed to have recurrent HCC. The objective of the study is to assess the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target population. Contact Dr. Lietao Li at (65) 6224 6157 or clinicaltrials@liontcr.com and refer to NCT02719782. (Study ID # LTCR-HCC-I-2) 

The Investigation of Peginterferon Alfa-2a on the RFS of the Subjects with HCC Who Have Been Treated by Resection – China
The current study is a prospective, randomized, open, multi-center investigation. The aim of current study is to investigate whether the Recurrence-free Survival Rate (RFS) of the hepatitis B related -hepatocellular carcinoma subjects who have been treated by resection can be improved by peginterferon alfa-2a. Contact: Lunxiu Qin at 52887172 or qinlx@fudan.edu.cn or Huliang Jia at jbl-1@163.com and refer to NCT03253250. (Study ID # PEG-HCC) 

Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection – China (Not yet recruiting)
Efficacy and safety of Thymalfasin adjuvant therapy in HBV-related HCC after curative resection. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. This study’s sponsor is Jia fan and SciClone Pharmaceuticals. Refer to identifier NCT02281266. (Study ID # ZDX-2014-05)

Yang Yin Fu Zheng Therapy in HBV Associated Hepatocellular Carcinoma (YYFZTIHBVHCC) – China
The purpose of this study is to observe the efficacy of routine medical care combined with Yang Yin Fu Zheng therapy for patients belong to HBV-HCC. Contact Zhiyun Yang at +861343969688 or 13439696988@163.com and refer to NCT02927626. (Study ID # BeijingDH)

The Role of the Vitamin D Receptor Gene Polymorphisms in Hepatocarcinogenesis – Egypt
Vitamin D levels may influence cancer development.  Vitamin D receptor (VDR gene polymorphisms) have also been investigated as impacting chronic hepatitis B, primary biliary cirrhosis and autoimmune hepatitis. A significant association of VDR (ApaI) polymorphism with the development of HCC (liver cancer) in chronic HCV infection may help to identify those who are at high risk of developing HCC. Contact: Sherief Abd-elsalam at 00201095159522 or email sheriefabdelsalam@yahoo.com and refer to identifier NCT02461979.

Sonazoid Enhanced Liver Cancer Trial For Early Detection– Japan
Use of contrast enhanced ultrasound (US) using Sonazoid vs. conventional B-mode US for early HCC detection.  Contact: Masatoshi Kudo at +81 72-366-0221 ext. 3149 or m-kudo@med.kindai.ac.jp, or Dr. KazuomiUeshima at +81-72-366-0221 ext. 3525, kaz-ues@med.kindai.ac.jp and refer to identifier – NCT00822991 (Study ID # JLOG08001, UMIN000001612)

Boramae Hospital Liver Cirrhosis Patient Cohort Study- Korea
The goal of this study is to describe the natural history of a large number of patients with liver cirrhosis prospectively followed, and to identify predictors of the occurrence of hepatocellular carcinoma. Contact Sae Kyung Joo at 821089619285 or joo.sammy@gmail.com and refer to identifier NCT01943318. (Study ID # BRM_LC_Cohort)

Prompt or Watchful Monitoring for Hepatitis B Virus Related Hepatocellular Carcinoma Without Elevated viRal Load (POWER) – Korea (Not yet recruiting)
This trial will investigate and determine the efficacy of the nucleos(t)ide analogue (NUC) treatment with Tenofovir disoproxil fumarate (Viread®) as measured by the cumulative incidence rate of hepatocellular carcinoma (HCC) at 3 year after curative treatment with radiofrequency ablation (RFA) or surgical resection (SR) in chronic hepatitis B virus (HBV) infected patients with low viral load. Contact: Seung Woon Paik at 82-2-3410-3409 or sw.paik@samsung.com or Dong Hyun Sinn at 82-2-3410-3012 or dh.sinn@samsung.com and refer to NCT02308319. (Study ID # 2014-09-149)

Stereotactic Body Radiotherapy (SBRT) for UnresectableHepatocellular Carcinoma (SBRT for HCC) – Korea
This study evaluates the effectiveness and adverse event of SBRT in the patients who had solitary 3 cm or less size HCC without extrahepatic lesion and vascular involvement. Contact HeeChul Park at 82-2-3410-2612 or hee.ro.park@samsung.com and refer to identifier NCT01910909. (Study ID # 2013-06-005-001)

Transarterial Radioembolization Versus Chemoembolization for the Treatment of Hepatocellular Carcinoma – Saudi Arabia
This randomized controlled trial is designed to prospectively compare TACE and 90Y for treatment of patients with unresectable (BCLC intermediate stage) HCC. Contact Mohamed I Al Sebayel at +966114647272 ext 24818 or msebayel@kfshrc.edu.sa and refer to identifier NCT02729506. (Study ID # 2131 134)

The Safety and Maximum Tolerated Dose of Axitinib in Combination With Radiotherapy for HCC – Taiwan
This is a phase I clinical trial evaluating the safety and MTD of axitinib in combination with RT for advanced HCC. Contact Dr. Yu-Min Li at +886-28332211 ext 2031 or M001063@ms.skh.org.tw and refer to identifier NCT02814461. (Study ID # 20150704M)

HBV-host cfDNA as Minimal Residual Tumor Marker for HBV-related HCC (Liver Cancer) – Taiwan
HBV DNA integration has been found in the chromosomes of about 90% of HBV-related HCC and the integration site is unique to individual HCC. The HBV-host junction DNA fragment from one HCC is therefore a tumor-specific biomarker. Investigators will develop either HBV-specific inverse PCRs or capture-sequencing protocols to identify HBV integrations sites in the tumor chromosomes in patients who have had an HBV-related liver cancer tumor removed surgically. Contact: Pei-Jer Chen, PhD, MD, +886-2-23123456 ext 67072 or email peijerchen@ntu.edu.tw and refer to identifier NCT03020342. (Study ID # 201510056RINA)