Neoadjuvant Radiotherapy for HCC Involving Type I PVTT

Phase 2

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT04025437
• Lead Sponsor: Guangxi Medical University

Brief Summary

The rate of patients with hepatocellular carcinoma (HCC) involving portal vein tumor thrombus (PVTT) is up to 50% in Guangxi province, China. Some of them will receive hepatic resection, especially those with type I or II PVTT. However, 5-years recurrence rate is up to 75% after surgery. Some retrospective studies found postoperative radiotherapy may reduce the rate of recurrence. Moreover, few retrospective studies also found neoadjuvant radiotherapy (PMID: 27317960) may improve overall survival for HCC patients involving type II/III PVTT. However, the safety and efficacy of neoadjuvant raidotherapy for HCC involving type I PVTT is unknown.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-07-17
• Study First Submitted QC: 2019-07-17
• Study First Posted: 2019-07-18
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-01
• Last Update Posted: 2019-09-04
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 214

Inclusion Criteria

• Age 18-75 years;
• Patients with resectable primary hepatocellular carcinoma and Cheng's type I portal vein tumor thrombus;
• Child-Pugh A or B (7 score) liver function;
• With more than 3 months expected survival;
• The volume of residual liver more than 30%;
• Patients agree to take part in.

Exclusion Criteria

• Patients with primary hepatocellular carcinoma and Cheng's type II/III/IV portal vein tumor thrombus
• Previous history of epigastric radiotherapy
• With extrahepatic metastasis
• With radiotherapy contraindication;
• Pregnant woman or sucking period;
• With repture tumor;
• With other cancer in previous five years;
• With chemothrapy, target therapy or immunosuppressive drugs therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year	From the date of hepatectomy or neoadjuvant radiotherapy to death or the end of follow-up.

Secondary Outcome Measures

Name	Time	Method
Recurrence-free survival	1 year	From the date of hepatectomy to HCC recurrence or the end of follow-up.

Trial Locations

Locations (1)

Department of Hepatobilliary Surgery, Affiliated Tumor of Guangxi University; 🇨🇳 Nanning, Guangxi, China