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

NCT ID: NCT02309788

Last Updated: 2016-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31

Brief 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.

Conditions

HepatoCellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

RT

Resectable HCC patients adjuvant RT for PVT or NM

No interventions assigned to this group

No RT

Resectable HCC patients adjuvant other treatment for PVT or NM

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

TaoBai

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

TaoBai

Nanning, Guangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bai Tao, MD

Role: CONTACT

25859373@qq.com

+86 18507712632

Facility Contacts

Tao Bai, MD

Role: primary

25859373@qq.com

+86 13878862632

Other Identifiers

TAOBAI

Identifier Type: -

Identifier Source: org_study_id