Neoadjuvant HAIC for Resectable Hepatocellular Carcinoma Beyond Milan Criteria

NCT03469479 | Unknown Phase 3 DMC

• 1 other identifier: HCC-180302
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of resection plus neoadjuvant hepatic arterial infusion chemotherapy (HAIC) compared with resection alone in patients with resectable hepatocellular carcinoma beyond Milan criteria.

Conditions

Hepatocellular Carcinoma

Keywords

Neoadjuvant hepatic arterial infusion chemotherapy; BCLC A/B; FOLFOX; Resection

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Time to death

  60 months

Secondary Outcomes (2)

• Disease-free survival

  60 months

• Adverse Events

  30 days

Study Arms (2)

Resection plus HAIC with FOLFOX

EXPERIMENTAL

Patients receive 4 times of neoadjuvant hepatic arterial infusion chemotherapy with FOLFOX and hepatic resection

Drug: FOLFOX; Procedure: Hepatic resection

Resection

ACTIVE COMPARATOR

Patients receive hepatic resection without neoadjuvant hepatic arterial infusion chemotherapy

Procedure: Hepatic resection

Interventions

FOLFOX DRUG

Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin

Also known as: Hepatic Arterial Infusion Chemotherapy of FOLFOX

Resection plus HAIC with FOLFOX

Hepatic resection PROCEDURE

R0 resection

Resection; Resection plus HAIC with FOLFOX

Eligibility Criteria

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

You may qualify if:

• The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL;
• Tumor burden beyond Milan criteria
• Diagnosed as resectable with consensus by the panel of liver surgery experts;
• No past history of resection, radiofrequency ablation, TACE, TAI, chemotherapy or molecule-targeted treatment;
• No Cirrhosis or cirrhotic status of Child-Pugh class A only;
• Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin
• ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine
• ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) \>1,500/mm3;

You may not qualify if:

• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
• Known history of HIV
• History of organ allograft
• Known or suspected allergy to the investigational agents or any agent given in association with this trial.
• Evidence of bleeding diathesis.
• Any other hemorrhage/bleeding event \> CTCAE Grade 3
• Serious non-healing wound, ulcer, or bone fracture
• Known central nervous system tumors including metastatic brain disease
• Poor compliance that can not comply with the course of treatment and follow up.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (7)

Dongguan People's Hospital

Dongguan, Guangdong, 523059, China

RECRUITING

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangzhou Twelfth People's Hospital

Guangzhou, Guangdong, 510620, China

RECRUITING

Kaiping Central Hospital

Kaiping, Guangdong, 529300, China

RECRUITING

The First Affiliated Hospital of University Of South China

Hengyang, Hunan, 421001, China

RECRUITING

First Affiliated Hospital Of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Folfox protocol

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

Study Officials

• Ming Shi, MD

  The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Shi, MD

CONTACT

(8620)-87343938; shiming@sysu.edu.cn

RongPing Guo, MD

CONTACT

(8620)-87342266; guorp@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: Proffessor

Study Record Dates

• First Submitted: March 11, 2018
• First Posted: March 19, 2018
• Study Start: March 2, 2018
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: August 2, 2018

Record last verified: 2018-07

Locations

CN (7)