The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Hepatocellular Carcinoma And Portal Vein Tumor Thrombosis (PVTT) Who Underwent Hepatectomy : A Random, Controlled, Stage III Clinical Trial.

NCT03368651 | Recruiting Phase 3

• 1 other identifier: B2017-076-01
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the impact on survival of neo-adjuvant TAI for patients with HCC and PVTT who underwent hepatectomy.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  overall survival

  From date of randomization until the date of death from any cause, assessed up to 60 months

Secondary Outcomes (2)

• recurrence-free survival (RFS)

  From date of randomization until the date of recurrence, assessed up to 60 months

• recurrence rate

  1 year, 2 year, 3 year, 5 year after surgery

Study Arms (2)

treatment group

EXPERIMENTAL

transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

Procedure: TAI

control group

NO INTERVENTION

no neo-adjuvant treatment before operation

Interventions

TAI PROCEDURE

transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)

treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years old and younger than 75 years;
• ECOG PS≤1;
• proven hepatocellular carcinoma according patological examination or EASL/AASLD diagnostic criteria;
• not previous treated for tumor;
• estimated tumor and tumor thrombosis could be removed en bloc in operation;
• no distant metastasis;
• the lab test could meet: neutrophil count≥2.0×109/L; hemoglobin≥100g/L; platelet count≥75×109/L; serum albumin≥35g/L; total bilirubin\<2-times upper limit of normal; ALT\<3-times upper limit of normal; AST\<3-times upper limit of normal; serum creatine\<1.5-times upper limit of normal; PT≤upper limit of normal plus 4 seconds; INR≤2.2;
• sign up consent;

You may not qualify if:

• cannot tolerate TAI or surgery;
• distant metastasis exits;
• known history of other malignancy;
• be allergic to related drugs;
• underwent organ transplantation before;
• be treated before (interferon included);
• known history of HIV infection;
• known history of drug or alcohol abuse;
• have GI hemorrhage or cardiac/brain vascular events within 30 days;
• pregnancy;

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Cancer Center of Sun Yat-Sen University

Guangzhou, Guangdong, +86, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Shaohua Li, MD

CONTACT

+8615088064187; lishaoh@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 11, 2017
• Study Start: January 1, 2016
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

CN (1)