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

Guangxi Medical University

Status: Unknown

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: folfox4 chemotherapy regimen; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02813096

GuangxiMUJYe

Details and patient eligibility

About

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

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups, including a placebo group

folfox4 chemotherapy regimen

Experimental group

Description:

details in the "Intervention Description"

Treatment:

Drug: folfox4 chemotherapy regimen

Placebo

Placebo Comparator group

Description:

details in the "Intervention Description"

Treatment:

Other: Placebo