AzTrials
AzTrials

HepatoCellular CarcinomaPhase 3NCT02973685

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

A Phase 3 study testing Hepatic arterial infusion chemotherapy, Transarterial chemoembolization and Folfox Protocol in people with HepatoCellular Carcinoma, run by Sun Yat-sen University at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 large hepatocellular carcinoma staged BCLC A/B. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HepatoCellular Carcinoma
What is being tested?
Hepatic arterial infusion chemotherapy, Transarterial chemoembolization and Folfox Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
3 sitesChina
Study dates
1 Oct 2016to 28 Nov 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • The First People's Hospital of Foshan

    Foshan, Guangdong, 510060

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong, 510060

  • Guangzhou Twelfth People's Hospital

    Guangzhou, Guangdong, 510620

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Hepatic arterial infusion chemotherapy, Transarterial chemoembolization, Folfox Protocol, TACE Drug Protocol
Keywords
Hepatic arterial infusion chemotherapy, Transarterial Chemoembolization, BCLC A/B
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hepatic arterial infusion chemotherapyProcedure or surgery

    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.

  • Transarterial chemoembolizationProcedure or surgery

    Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.

  • Folfox ProtocolDrug

    Also called Folfox for TAI

    oxaliplatin,leucovorin and 5-FU

  • TACE Drug ProtocolDrug

    Also called Drugs for transarterial chemotherapy and embolization

    lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, with or without MMC) followed by polyvinyl alcohol particles (PVA)

Study groups in NCT02973685
Study groupRoleWhat they receive
Hepatic arterial infusion chemotherapyExperimentalProcedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: Folfox Protocol
Transarterial chemoembolizationActive comparatorProcedure/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).
Receives: Procedure: Transarterial chemoembolization; Drug: TACE Drug Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 24 months

Secondary outcomes (3)

  1. Time to progression

    Measured: 24 months

  2. Adverse Events

    Postoperative adverse events were graded based on CTCAE v4.03

    Measured: 30 Days after HAIC

  3. Number of of Patients developed Adverse Events

    Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v3.0

    Measured: 30 Days after HAIC

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2016 (estimated)
  2. Study start1 Oct 2016
  3. Primary completion28 Nov 2020
  4. Study completion28 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02973685
Sponsor's protocol ID
HCC-S023
Status last verified
Jun 2023
First submitted
20 Nov 2016
Last updated
12 Jun 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Han X, Peng C, Ruan SM, Li L, He M, Shi M, Huang B, Luo Y, Liu J, Wen H, Wang W, Zhou J, Lu M, Chen X, Zou R, Liu Z. A Contrast-Enhanced Ultrasound Cine-Based Deep Learning Model for Predicting the Response of Advanced Hepatocellular Carcinoma to Hepatic Arterial Infusion Chemotherapy Combined With Systemic Therapies. Cancer Sci. 2025 Jul;116(7):1930-1940. doi: 10.1111/cas.70089. Epub 2025 Apr 29.

    PubMed 40302359

  • Li QJ, He MK, Chen HW, Fang WQ, Zhou YM, Xu L, Wei W, Zhang YJ, Guo Y, Guo RP, Chen MS, Shi M. Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin Versus Transarterial Chemoembolization for Large Hepatocellular Carcinoma: A Randomized Phase III Trial. J Clin Oncol. 2022 Jan 10;40(2):150-160. doi: 10.1200/JCO.21.00608. Epub 2021 Oct 14.

    PubMed 34648352

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hepatic arterial infusion chemotherapy, Transarterial chemoembolization and Folfox Protocol in people with HepatoCellular Carcinoma, run by Sun Yat-sen University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02973685, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2023.

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