Study of Folfox4 Chemotherapy Regimen to Prevent Early Postoperative Recurrence for HCC-PVTT Patients

Not Applicable

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: folfox4 chemotherapy regimen; Other: Placebo

• Registration Number: NCT02813096
• Lead Sponsor: Guangxi Medical University

Brief Summary

This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for hepatocellular carcinoma patients with portal vein tumor thrombus following curative resection

Detailed Description

Curative resective is well-accepted as the predominant treatment for hepatocellular carcinoma (HCC) patients. Unfortunately, the long-term prognosis remains poor due to frequent postoperative recurrence, especially in HCC patients with portal vein tumor thrombus (PVTT). When PVTT invades into the portal vein system, tumor cell spreads and distributes along with the portal vein and its branches,thus resulting in intra-hepatic micro-metastasis which contributes to early recurrence for patients following curative resection. Postoperative adjuvant interventions include TACE, antiviral therapy, immunotherapy, local radiotherapy were applied to prevent recurrence. However, the efficacy and safety of these regimens remains unsatisfactory. Thus new therapeutic strategy remains to be investigated. This study is to investigate the efficacy and safety of Folfox4 chemotherapy regimen to prevent early recurrence for HCC patients with PVTT following curative resection.

Study Timeline

• Study First Submitted: 2016-06-16
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-24
• Status Verified: 2016-10
• Study Start: 2016-10
• Last Update Submitted: 2016-10-21
• Last Update Posted: 2016-10-25
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• patients undergo curative resection
• HCC with PVTT is confirmed by pathological examination
• patients undergo chemotherapy of Folfox4 regimen
• patients without recurrence within the first month after curative resection
• residual hepatic function is Child-pugh A or B which is capable to tolerate chemotherapy
• patients without other postoperative adjuvant treatments including TACE, radiotherapy, immunotherapy

Exclusion Criteria

• Multipal intra-hepatic or outra-hepatic tastasis within the first month after curative resection
• patients with residual hepatic function Child-pugh C is not capable to tolerate chemotherapy
• patients undergo postoperative adjuvant treatments except chemotherapy of Folfox4 regimen
• patients with badly chemotherapy complications who can finish the whole Folfox4 treatment course

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
folfox4 chemotherapy regimen	folfox4 chemotherapy regimen	details in the "Intervention Description"
Placebo	Placebo	details in the "Intervention Description"

Primary Outcome Measures

Name	Time	Method
early recurrence	from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years

Secondary Outcome Measures

Name	Time	Method
overall survival	from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years