The Impact on Survival of Neo-adjuvant Transarterial Chemoinfusion (TAI) for Patients With Beyond Milan Criteria BCLC Stage A/B Hepatocellular Carcinoma Who Underwent Hepatectomy

NCT03851913 | Unknown Phase 3

• 1 other identifier: B2018-165-01
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the impact on survival of neo-adjuvant TAI for patients with beyond Milan criteria BCLC stage A/B HCC who underwent hepatectomy.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• OS

  overall survival

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

Secondary Outcomes (3)

• 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

• PFS

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

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;
• the tumor was diagnosed as BCLC stage A/B and beyond Milan criteria;
• 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;

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)

SUN YAT-SEN University Cancer Center

Guangzhou, Guangdong, 510060, 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: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 22, 2019
• Study Start: July 1, 2018
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2024
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

CN (1)