HAIC Plus Sorafenib Versus TACE Plus Sorafenibfor Advanced HCC

NCT02856126 | Completed Phase 3 DMC

• 1 other identifier: HCC-S022
• Study Type: interventional
• Target: 214
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with BCLC stage hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma

Keywords

Hepatic arterial infusion chemotherapy; Transarterial Chemoembolization

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Overall survival

  18 months

Secondary Outcomes (3)

• Progress free survival

  18 months

• Adverse Events

  30 Days

• Number of of Patients developed Adverse Events

  30 Days

Study Arms (2)

HAIC plus sorafenib

EXPERIMENTAL

Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: HAIC Regimen Drug: Oral Sorafenib

Procedure: Hepatic arterial infusion chemotherapy; Drug: HAIC Regimen; Drug: Oral Sorafenib

TACE plus sorafenib

ACTIVE COMPARATOR

Procedure/Surgery: Transarterial chemoembolization Drug: TACE regimen Drug: Oral Sorafenib

Procedure: Transarterial chemoembolization; Drug: TACE regimen; Drug: Oral Sorafenib

Interventions

Hepatic arterial infusion chemotherapy PROCEDURE

HAIC plus sorafenib

Transarterial chemoembolization PROCEDURE

TACE plus sorafenib

TACE regimen DRUG

infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)

TACE plus sorafenib

HAIC Regimen DRUG

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

HAIC plus sorafenib

Oral Sorafenib DRUG

Oral Sorafenib, 400mg, Bid

HAIC plus sorafenib; TACE plus sorafenib

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 BCLC C stage HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
• Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
• with no previous treatment
• No Cirrhosis or cirrhotic status of Child-Pugh class A only
• Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
• The following laboratory parameters:
• Platelet count ≥ 75,000/µL
• Hemoglobin ≥ 8.5 g/dL
• Total bilirubin ≤ 30mmol/L
• Serum albumin ≥ 30 g/L
• ASL and AST ≤ 5 x upper limit of normal
• Serum creatinine ≤ 1.5 x upper limit of normal
• INR ≤ 1.5 or PT/APTT within normal limits
• Absolute neutrophil count (ANC) \>1,500/mm3
• Ability to understand the protocol and to agree to and sign a written informed consent document

You may not qualify if:

• Main portal vein occlusion
• 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.
• Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
• Evidence of bleeding diathesis.
• Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
• Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug
• Serious non-healing wound, ulcer, or bone fracture
• Known central nervous system tumors including metastatic brain disease

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (7)

Dongguan People's Hospital

Dongguan, Guangdong, 523059, China

Location

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Guangzhou Twelfth People 's Hospital

Guangzhou, Guangdong, 510620, China

Location

Kaiping Central Hospital

Kaiping, Guangdong, 529300, China

Location

The First Affiliated Hospital of University Of South China

Hengyang, Hunan, 421001, China

Location

The First Affiliated Hospital Of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

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

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Ming Shi, MD

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

  PRINCIPAL INVESTIGATOR

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: August 2, 2016
• First Posted: August 4, 2016
• Study Start: August 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: July 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Locations

CN (7)