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Hepatocellular Carcinoma, AdultNCT02964260

RCT of TAE Simultaneously Combined Thermal Ablation for Large Hepatocellular Carcinoma

A study testing Chemotherapy drug, Embolic agents and Simultaneously in people with Hepatocellular Carcinoma, Adult, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study intends to evaluate the efficacy and safety of Transarterial embolization (TAE) simultaneously combined with thermal ablation for large hepatocellular carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatocellular Carcinoma, Adult
What is being tested?
Chemotherapy drug, Embolic agents and Simultaneously
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
1 siteChina
Study dates
May 2016to Dec 2022
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 to 70 years with estimated survival over 3 months
  • Number of tumors < 3
  • Diameter of tumor between 5cm to 15cm
  • No portal vein trunk tumoral thrombus or inferior vena cava tumoral thrombus
  • With arteriovenous fistula or arterioportal shunt fistula that can be completely embolized
  • Child-Pugh class A or B/Child score > 7;ECOG score < 2
Show all 9Show fewer
  • Tolerable coagulation function or reversible coagulation disorders
  • Laboratory examination test: WBC≥3.0×10E9/L; Hb≥3.0×10E9/L; PLT ≥50×10E9/L; INR < 2.3 or PT< 16.5s; Cr ≤ 145.5 umul/L
  • Signed informed consent before recruiting

Who cannot join

  • Diffused HCC
  • With portal vein trunk tumoral thrombus
  • With inferior vena cava tumoral thrombus or hepatic vein tumor thrombus
  • With lymphatic metastasis or extra hepatic metastasis
  • Child-Pugh class C and can't be improved by expectant treatment
  • Untreatable coagulation disorders, severe hemogram abnormal and bleeding tendency
  • Massive intractable ascites
  • ECOG score > 2

Trial locations and contacts

1 site in 1 country.

Jinhua Huang, Ph.D contact

0086-20-87343272

huangjh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Jinhua Huang, Ph.D, 0086-20-87343447

    Jinhua Huang, Ph.D

    Recruiting

Other trials in China

About this study

Official title: Randomized Controlled Trial of Transarterial Embolization Simultaneously Combined Thermal Ablation for Large Hepatocellular Carcinoma

This study intends to evaluate the efficacy and safety of Transarterial embolization (TAE) simultaneously combined with thermal ablation for large hepatocellular carcinoma (HCC). Half participants will receive TAE simultaneously combined with thermal ablation and the other half receive TACE sequentially combined with thermal ablation, which is a conventional treatment for HCC patients.

Read the detailed description

The treatment method "Transarterial chemoembolization (TACE) sequentially combined with thermal ablation" is recommend for large HCC patients from NCCN Guideline and Chinese guideline "Diagnosis and Treatment of Primary Liver Cancer". The details of this sequential method consist one or more times of TACE followed by thermal ablation at least one month later to make the tumor completely inactivate. The thermal ablations include multiple applicators radiofrequency or microwave ablations. However, this method includes such disadvantages. 1) The limitation of lipiodol dosage in one TACE session is 30ml so that many patients needs more sessions of TACE; (2) Lipiodol and chemical drugs is easy to leak when patients have hepatic arteriovenous fistula. (3) Repeated TACE could cause more serious side effects. (4) Tumors of many patients are still not controlled or grow too large to ablate after TACEs which increases the metastasis risk and affects the efficacy and survival time.

However, TAE simultaneously combined with thermal ablation is another combination type which reduce the interval time between two procedures from one month to 1-3 days. TAE removes the chemical drugs and uses embolic agents such as Embosphere to obstruct vessels to enhance the effect of followed ablations. The main aim of reducing interval and remove chemical drugs is to make the tumor completely inactivate in one hospitalization like surgical operation, hoping bringing less side effects, better efficacy and longer survival time.

Thus the investigators will launch a prospective, multicenter randomized controlled clinical trial to compare the 3-years overall survival, safety, social and economic benefit of TAE simultaneously combined with ablation and TACE sequentially combined with ablation. The investigators expect to acquire Ia-level evidence-based medical evidence which can be accepted by the clinical guideline, popularizing, demonstrating our therapy.

Being tested
Chemotherapy drug, Embolic agents, Simultaneously, Sequentially, Ablation
Keywords
HCC; Embolization; Ablation; simultaneously; sequentially
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Chemotherapy drugDrug

    Also called Chemotherapy

    Doxorubicin/Platinum agents

  • Embolic agentsDrug

    Also called Embolization

    Lipiodol/Gelatin sponge/PVA/Blank microspheres

  • SimultaneouslyProcedure or surgery

    Also called Treatment interval

    1-3 days

  • SequentiallyProcedure or surgery

    Also called Treatment interval

    1 month

  • AblationDevice

    Also called RFA/MWA

    Radiofrequency ablation/Microwave ablation

Study groups in NCT02964260
Study groupRoleWhat they receive
TAE combined ablation simultaneouslyExperimentalTAE simultaneously combined with ablation.The treatment interval is 1-3 days between two procedures. TAE using embolic agents(Lipiodol/Gelatin sponge/PVA particles(300～500μm)/Blank microspheres).
Receives: Drug: Embolic agents; Procedure: Simultaneously; Device: Ablation
TACE combined ablation sequentiallyOtherTACE sequentially combined thermal ablation.The treatment interval is 1 month between two procedures. TACE using chemotherapy drug(Doxorubicin/platinum agents) and embolic agents(Lipiodol/Gelatin sponge/PVA particles(300～500μm)/Blank microspheres).
Receives: Drug: Chemotherapy drug; Drug: Embolic agents; Procedure: Sequentially; Device: Ablation

What is being measured

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

  1. Overall survival

    From complete remission of the index large tumor to patient death or the completion of this trial

    Measured: 3 years

Secondary outcomes (4)

  1. Recurrence free survival

    From complete remission of the index large tumor to tumor recurrence either in- or extra- hepatic or the completion of this trial

    Measured: 3 years

  2. liver and renal function

    Alanine aminotransferase,Ast,total bilirubin,albumin,creatinine,Urea nitrogen

    Measured: 3 years

  3. Complications

    number of participants with Complications

    Measured: 3 years

  4. Times of interventional procedures

    The number of procedures for each patient, either TACE/TAE or ablation

    Measured: 3 years

Timeline

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

  1. First posted16 Nov 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
410 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02964260
Sponsor's protocol ID
TASAL
Status last verified
May 2021
First submitted
9 Nov 2016
Last updated
14 May 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Chemotherapy drug, Embolic agents and Simultaneously in people with Hepatocellular Carcinoma, Adult, run by Sun Yat-sen University at 1 site 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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Results are not available in the source record.

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

Contact Jinhua Huang, Ph.D (0086-20-87343272, huangjh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 3 years). 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 NCT02964260.

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 14 May 2021.

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