HAIC Versus TACE for Large Hepatocellular Carcinoma Staged BCLC A/B.

June 8, 2023 updated by: Shi Ming, Sun Yat-sen University

The Efficacy and Safety of Hepatic Arterial Infusion Chemotherapy Compared With Transarterial Chemoembolization as Initial Treatment in Patients With Large Hepatocellular Carcinoma Staged BCLC A/B.

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 large hepatocellular carcinoma staged BCLC A/B.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Transarterial chemoembolization (TACE) is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients. While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma staged BCLC A/B especially for those with tumor larger than 10 cm. Our previous prospective study also revealed similar results of large HCC patients treated with TACE. Recently, the results of our preliminary pilot study suggested that, compared with TACE, hepatic arterial infusion chemotherapy (HAIC) may improve the survivals for HCC with large HCC. Thus, the investigators carried out this prospective randomized control to demonstrate the superiority of HAIC over TACE.

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China, 510060
        • The First People's Hospital of Foshan
      • Guangzhou, Guangdong, China, 510060
        • Cancer Center Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510620
        • Guangzhou Twelfth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age range from 18-75 years;
  • KPS≥70;
  • The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL), simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system.
  • Patients must have at least one tumor lesion that can be accurately measured;
  • The sum of diameters of all lesions longer than 10 cm with the maximum lesion longer than 7 cm.
  • Diagnosed as unresectable with consensus by the panel of liver surgery experts;
  • Re commanded treated by TAI or TACE with consensus by the panel of liver MDT;
  • No past history of 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;
  • Ability to understand the protocol and to agree to and sign a written informed consent document.

Exclusion Criteria:

  • 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 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
  • Poor compliance that can not comply with the course of treatment and follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hepatic arterial infusion chemotherapy
Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Procedure: Hepatic arterial infusion chemotherapy
A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially.
Drug: Folfox Protocol
oxaliplatin,leucovorin and 5-FU
Other Names:
  • Folfox for TAI
Active Comparator: Transarterial chemoembolization
Procedure/Surgery: Transarterial chemoembolization Drug: TACE Drug Protocol. Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, with or without MMC), and embolization with polyvinyl alcohol particles (PVA).
Procedure: Transarterial chemoembolization
Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.
Drug: TACE Drug Protocol
lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, with or without MMC) followed by polyvinyl alcohol particles (PVA)
Other Names:
  • Drugs for transarterial chemotherapy and embolization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to progression
Time Frame: 24 months
24 months
Adverse Events
Time Frame: 30 Days after HAIC
Postoperative adverse events were graded based on CTCAE v4.03
30 Days after HAIC
Number of of Patients developed Adverse Events
Time Frame: 30 Days after HAIC
Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0
30 Days after HAIC

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

First People's Hospital of Foshan
Guangzhou No.12 People's Hospital

Investigators

  • Principal Investigator: Ming Shi, MD, The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

November 28, 2020

Study Completion (Actual)

November 28, 2020

Study Registration Dates

First Submitted

November 20, 2016

First Submitted That Met QC Criteria

November 22, 2016

First Posted (Estimated)

November 25, 2016

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC-S023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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