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

NCT ID: NCT02813096

Last Updated: 2016-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2018-07-31

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.

Conditions

Carcinoma, Hepatocellular

Keywords

HCC; PVTT; Folofox4; Early Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

folfox4 chemotherapy regimen

details in the "Intervention Description"

Group Type: EXPERIMENTAL

folfox4 chemotherapy regimen

Intervention Type: DRUG

Folfox regimen:Oxaliplatin 85 mg/m2 in 250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1;leucovorin 200 mg/m2 in 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 400 mg/m2 5-FU in 20mL 0.9% NaCl solution, IV(administered as follow leucovorin); then 600 mg/m2 5-FU in 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle.

Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops.

Placebo

details in the "Intervention Description"

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo regimen:250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1; 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 20mL 0.9% NaCl solution, IV; then 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle.

Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops.

Interventions

folfox4 chemotherapy regimen

Folfox regimen:Oxaliplatin 85 mg/m2 in 250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1;leucovorin 200 mg/m2 in 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 400 mg/m2 5-FU in 20mL 0.9% NaCl solution, IV(administered as follow leucovorin); then 600 mg/m2 5-FU in 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle.

Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops.

Intervention Type: DRUG

Placebo

Placebo regimen:250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1; 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 20mL 0.9% NaCl solution, IV; then 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle.

Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops.

Intervention Type: OTHER

Other Intervention Names

F4 chemo; control

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangxi Medical University

OTHER

Sponsor Role: lead

Responsible Party

Jiazhou Ye

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lequn Li, M.D.

Role: STUDY_CHAIR

Cancer Hospital of Guangxi Medical University

Jiazhou Ye, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital of Guangxi Medical University

Central Contacts

Jiazhou Ye, M.D.

Role: CONTACT

Phone: +86 13367719078

Email: nnsz20013@163.com

Lequn Li, M.D.

Role: CONTACT

Phone: +86 15077679083

Email: Lequn_li001@163.com

Other Identifiers

GuangxiMUJYe

Identifier Type: -

Identifier Source: org_study_id