Radiotherapy in Hepatocellular Carcinomas After Hepatectomy With Narrow Margin (<1 cm) or Portal Vein Thrombosis

HepatoCellular Carcinoma Clinical Trial

— RHCC  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02309788
• Other study ID #: TAOBAI
• Status: Recruiting
• Phase: N/A
• First received: December 2, 2014
• Last updated: January 23, 2016
• Start date: January 2016

Study information

• Verified date: January 2016
• Source: Guangxi Medical University
• Contact: Bai Tao, MD
• Phone: +86 18507712632
• Email: 25859373[@]qq.com
• Is FDA regulated: No
• Health authority: National Health and Family Planning Commission : the People's Republic of China
• Study type: Observational

Clinical Trial Summary

Hepatocellular carcinoma (HCC) is one of ten leading cancer types worldwide and also in Asia, but the five-year relative survival rate is relatively quite low1-3. As a common complication of HCC, portal vein tumor thrombosis (PVTT) have been reported with an occurrence of 34% ~ 50% in advanced HCC and it is now become an extremely pressing problem for hepatic surgeon. Nevertheless, the patients overall survival (OS) varies on their clinical features or liver function4. For HCC PVTT treatment, current options are surgical resection, embolization chemotherapy, radiation therapy, a variety of ablation therapy, biological and gene therapy,etc. Among them, the use of radiation therapy is getting more and more attention, and it is changing from the past palliative treatment to current curable treatment. From an oncologic point of view, a narrow margin <1 cm is not safe and is often associated with higher rates of recurrence and shorter patient survival.On the other hand, it is also believed that most intrahepatic recurrences arise from multicentric carcinogenesis and are distant from the resection margin.To address this issue, the investigators are going to conduct a series of retrospective and prospective studies to investigate the effect of adjuvant RT for centrally located HCC after narrow margin (<1 cm) hepatectomy on tumor recurrence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• HCC with no preoperative RT

• resectable lesion that could be completely removed, at the same time retaining a sufficient residual liver tissue to maintain adequate function

• compensated cirrhosis or no cirrhosis; Child-Pugh A

• ECOG Performance Status of 0 or 1.

• Patients who had undergone transarterial chemoembolization (TACE) were eligible for enrollment in the study, provided this form of therapy ended at least 4 weeks before study entry

Exclusion Criteria:

• unresectable hepatocellular carcinoma patients

• Hepatocellular carcinoma without portal vein tumor thrombus

• Hepatectomy without narrow margin(more than 1cm)

• presence of distant metastasis

• palliative resection with tumor residual

• non-HCC confirmed by postoperative pathology

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• HepatoCellular Carcinoma

Locations

Country	Name	City	State
China	TaoBai	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		1year	Yes