- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02192671
HR Versus RFA for HCC in Patients With PHT (HR-HCC/PHT)
Hepatic Resection Versus Radiofrequency Ablation for Patients With Hepatocellular Carcinoma and Portal Hypertension
Study Overview
Status
Intervention / Treatment
Detailed Description
Cirrhosis is common among patients with hepatocellular carcinoma (HCC); in China, for example, it occurs in approximately 80% of HCC patients. Another common comorbidity of HCC is clinically significant portal hypertension (PHT), which occurs in 25-55% of patients with both HCC and cirrhosis. PHT correlates with the severity of cirrhosis, and it can complicate HCC treatment by increasing the risk of perioperative hemorrhage and liver failure.
Hepatic resection (HR) is a widely used radical therapy for HCC. Although HR is often suitable for HCC patients with cirrhosis, it is widely regarded as unsuitable for HCC patients with PHT because of the potential for postoperative hepatic decompensation. In fact, the absence of PHT is the best predictor of excellent HR outcomes. Guidelines of the American and European Associations for the Study of Liver Disease do not recommend HR as an option for HCC patients with PHT. Several studies, however, have reported that HCC patients with and without clinically significant PHT showed similar short- and long-term outcomes after HR. This controversy is important to resolve because more than 25% of cirrhotic patients with HCC also present with PHT.
Actually, official guidelines recommend liver transplatation for patients with HCC and PHT. However, implementation of liver transplantation is restricted by the lack of liver donation and the high cost of the procedure in many countries, especially China. However, as a minimally invasive therapy, radiofrequency ablation (RFA) is a popular treatment modality for patients with HCC within Milan Criteria. Moreover, randomized controlled trials have validated and proposed its clinical usage.
So here, we plan to address the safety and efficacy of HR comparing with RFA for HCC patients with PHT using a population from Guangxi province of China, where the population shows the highest HCC incidence in the world.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Jian-Hong Zhong, MD
- Phone Number: 86-771-5330855
- Email: zhongjianhong66@163.com
Study Locations
-
-
Guangxi
-
Nanning, Guangxi, China, 530021
- Recruiting
- Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University
-
Contact:
- Jian-Hong Zhong, MD
- Phone Number: 86-771-5330855
- Email: zhongjianhong66@163.com
-
Principal Investigator:
- Jian-Hong Zhong, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18-75 years
- In the HR group, clinical diagnosis of HCC was confirmed by histopathological examination of surgical samples in all patients; in the RFA group, HCC diagnosis was confirmed by two types of clinical imaging (ultrasonography, computed tomography, or magnetic resonance imaging), togetherwith a serum level of α-fetoprotein higher than 400 ng/mL. If diagnosis based on imaging andα-fetoprotein level was uncertain, needle biopsy was performed.
- Tumor stage fitted into Milan Criteria
- Patients with clinically relevant portal hypertension, which is defined as the presence of esophageal varices and/or a platelet count of less than 100 000 per μL in association with splenomegaly.
- Patients have Child-Pugh A or B liver function
- No previous neoadjuvant treatment
- No evidence of metastasis to the lymph nodes and/or distant metastases on the basis of preoperative imaging results and perioperative findings
- No malignancy other than HCC for 5 years prior to the initial HCC treatment
Exclusion Criteria:
- History of cardiac disease
- Known history of human immunodeficiency virus (HIV) infection
- Known Central Nervous System tumors including metastatic brain disease
- History of organ allograft
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study
- Pregnant or breast-feeding patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hepatic resection
Adequate remnant liver volume was 30% for HCC patients without cirrhosis, and >50% for HCC patients with chronic hepatitis, cirrhosis, or severe fatty liver.
|
Indications for HR are the presence of appropriate residual liver volume determined by volumetric computed tomography.
|
Active Comparator: Radiofrequency ablation
RFA is performed in less than one week after clinical diagnosis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 3 years
|
3 years
|
Hospital mortality
Time Frame: 90 day
|
90 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Recurrence rate
Time Frame: 3 years
|
3 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HRRFA-HCC/PHT (Registry Identifier: Jian-Hong Zhong)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neoplasms, Glandular and Epithelial
-
Catalysis SLRecruitingNeoplasms | Carcinoma | Neoplasia; Intraepithelial, Cervix | Glandular Neoplasms | Epithelial NeoplasmCuba
-
Providence Health & ServicesCelldex TherapeuticsEnrolling by invitationMalignant Epithelial NeoplasmsUnited States
-
Providence Health & ServicesActive, not recruitingMalignant Epithelial NeoplasmsUnited States
-
Genentech, Inc.CompletedEpithelial Tumors, MalignantSpain, United States
-
Synermore Biologics Co., Ltd.Synermore Biologics USA LimitedActive, not recruitingSolid Tumor | Epithelial CarcinomaUnited States
-
Vall d'Hebron Institute of OncologyBanc de Sang i TeixitsRecruiting
-
Institut CurieRecruiting
-
Sesen Bio, Inc.TerminatedNeoplasms, Glandular and EpithelialRussian Federation, Georgia
-
Akamis BioMerck Sharp & Dohme LLCRecruitingStudy of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY) (FORTIFY)Metastatic Cancer | Epithelial TumorUnited States, United Kingdom
-
National Cancer Institute (NCI)CompletedEpithelial Tumors, Malignant | Epithelial Neoplasms, Malignant | Malignant Mesenchymal TumorUnited States
Clinical Trials on Hepatic Resection
-
University of Milano BicoccaHumanitas Clinical and Research Center; Niguarda Hospital; Azienda Ospedaliero... and other collaboratorsRecruitingHepatocellular Carcinoma | Circulating Tumor Cell | Recurrent Hepatocellular CarcinomaItaly
-
University of Maryland, BaltimoreRecruiting
-
University of MilanCompletedHepatectomy | Bile Leak | Hepatic Resection | Biliary Fistula | Liver ResectionItaly
-
National Taiwan University HospitalNational Science Council, TaiwanUnknown
-
Humanitas Clinical and Research CenterCompletedHepatocellular Carcinoma
-
University of MilanCompletedHepatocellular Carcinoma | Cirrhosis | Multiple TumorsItaly
-
University of MilanCompletedHepatectomy | Surgery | Liver Tumors | Liver Resection
-
University of MilanCompleted
-
National Taiwan University HospitalUnknownColorectal CancerTaiwan
-
University of MilanUniversity of BolognaCompletedMultiple Minor Hepatectomies Versus Major or Extended Hepatectomies for Colorectal Liver Metastases.Colon Cancer | Colorectal Liver Metastases