Clinical trial NCT02813096: Study of Folfox4 Chemotherapy Regimen to Prevent Early Postoperative Recurrence for HCC-PVTT Patients
Official title: Efficacy and Safety Study of Folfox4 Chemotherapy Regimen to Prevent Early Recurrence of Hepatocellular Carcinoma Patients With Portal Vein Tumor Thrombus Following Curative Resection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Hepatocellular
Keywords: HCC
PVTT
Folofox4
Early Recurrence
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2016-06-24
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: early recurrence
timeFrame: from date of randomization until the first document recurrence from any cause, whichever came first, assessed up to 2 years
Secondary outcomes:
measure: overall survival
timeFrame: from date of randomization until the date of death from any cause, whichever came first, assessed up to 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Cancer Hospital of Guangxi Medical University
name: Lequn Li, M.D.
role: STUDY_CHAIR
affiliation: Cancer Hospital of Guangxi Medical University
name: Jiazhou Ye, M.D.
role: PRINCIPAL_INVESTIGATOR
References: