AzTrials
AzTrials

Carcinoma, HepatocellularPhase 3NCT02630108

TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma

A Phase 3 study testing Thermal Ablation, EADM and Ultra-fluid lipiodol in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Thermal Ablation, EADM and Ultra-fluid lipiodol
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
280 participants
Where
1 siteChina
Study dates
Dec 2015to Apr 2018
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months;
  • Patients with large HCC (>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC);
  • Patients with no thrombus in main portal vein (PV)
  • Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2;
  • Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy;
  • White blood cell count ≥ 3.0×10^9/L;
Show all 11Show fewer
  • Hemoglobin ≥ 8.5g/dl;
  • Platelet ≥ 50×10^9/L;
  • INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds;
  • Blood creatinine less than 1.5 times of upper limit of reference;
  • Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.

Who cannot join

  • Patients with diffuse type of liver cancer;
  • Cholangiocellular carcinoma
  • Patients with main PV thrombus;
  • Patients with hepatic vein thrombus;
  • Patients with lymph node or distant metastasis outside of liver;
  • Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection;
Show all 12Show fewer
  • Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency;
  • Patients with intractable massive ascites;
  • Patients' ECOG PS >2;
  • Patients complicated with active infection, especially cholangitis;
  • Patients with severe disorders of heart, lungs, kidneys, or brain;
  • Patients and/or their relatives refuse to anticipate this study.

Trial locations and contacts

1 site in 1 country.

Jianhua Wang, MD contact

+8613611759557

wang.jianhua@zs-hospital.sh.cn

Rong Liu, MD contact

+8613681971563

liu.rong@zs-hospital.sh.cn

China1 site, 1 recruiting

  • Department of Interventional Radiology, Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

    Jianhua Wang, MD, +8613611749557, wang.jianhua@zs-hospital.sh.cn

    Rong Liu, MD, +8613681971563, liu.rong@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of Transarterial Chemoembolization (TACE) Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma

It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.

Read the detailed description

It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (>5cm in diameter) and huge HCC (>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.

Being tested
Thermal Ablation, EADM, Ultra-fluid lipiodol, Gelatin sponge articles
Keywords
HCC, TACE, Thermal Ablation, Safety/Efficacy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Thermal AblationProcedure or surgery

    Also called Radiofrequency ablation, Microwave ablation

    Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.

  • EADMDrug

    Also called Epirubicin

    EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.

  • Ultra-fluid lipiodolDrug

    Also called lipiodol

    Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .

  • Gelatin sponge articlesOther

    Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.

Study groups in NCT02630108
Study groupRoleWhat they receive
Thermal Ablation & TACEExperimentalTransarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Receives: Procedure: Thermal Ablation; Drug: EADM; Drug: Ultra-fluid lipiodol; Other: Gelatin sponge articles
TACE aloneActive comparatorOnly TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
Receives: Drug: EADM; Drug: Ultra-fluid lipiodol; Other: Gelatin sponge articles

What is being measured

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

  1. Overall Survival

    Measured: From the date of randomization until the date of death from any cause, assessed up to 26 months

Secondary outcomes (5)

  1. Time-to-Disease Progression

    TTDP follow-up is done at three months interval after lesions defined as stable with treatment of TACE or ablation combined with synchronous TACE six months after enrollment until lesions are defined as disease progression.

    Measured: From the date of first procedure of TACE or TACE combined with synchronous ablation until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 26 months

  2. Objective response rate (ORR)

    The ratio of CR plus PR. The efficacy is defined as complete regression (CR), partial regression (PR), stable disease (SD) and progressive disease (PD) according to modified Response Evaluation Criteria in Solid Tumors (mRESIST)

    Measured: Six months after the date of first procedure of TACE or TACE combined with synchronous ablation.

  3. Progression free survival(PFS)

    Measured: From the date of first procedure of TACE or TACE combined with synchronous ablationto until the time when lesions are defined as disease progression or death by any cause,assessed up to 26 months.

  4. Numbers of TACE and TACE combined with ablation cycles

    The times of the subjects undergoing TACE or TACE combined with ablation

    Measured: From the date of randomization until the date of death, assessed up to 26 months.

  5. Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups

    Serious or mild adverse events after treatment

    Measured: From the date of randomization until the date of follow-up visit (30 days after the procedure of TACE or TACE combined with thermal ablation)

Timeline

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

  1. First posted15 Dec 2015 (estimated)
  2. Study startDec 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionApr 2018 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02630108
Sponsor's protocol ID
B2015-146R
Status last verified
Oct 2016
First submitted
3 Dec 2015
Last updated
18 Oct 2016
Results posted
No
Data monitoring committee
No

Publications

  • Siegel RL, Miller KD, Jemal A. Cancer statistics, 2015. CA Cancer J Clin. 2015 Jan-Feb;65(1):5-29. doi: 10.3322/caac.21254. Epub 2015 Jan 5.

    PubMed 25559415

  • Forner A, Llovet JM, Bruix J. Hepatocellular carcinoma. Lancet. 2012 Mar 31;379(9822):1245-55. doi: 10.1016/S0140-6736(11)61347-0. Epub 2012 Feb 20.

    PubMed 22353262

  • Zhang L, Yin X, Gan YH, Zhang BH, Zhang JB, Chen Y, Xie XY, Ge NL, Wang YH, Ye SL, Ren ZG. Radiofrequency ablation following first-line transarterial chemoembolization for patients with unresectable hepatocellular carcinoma beyond the Milan criteria. BMC Gastroenterol. 2014 Jan 10;14:11. doi: 10.1186/1471-230X-14-11.

    PubMed 24410841

  • Mabed M, Esmaeel M, El-Khodary T, Awad M, Amer T. A randomized controlled trial of transcatheter arterial chemoembolization with lipiodol, doxorubicin and cisplatin versus intravenous doxorubicin for patients with unresectable hepatocellular carcinoma. Eur J Cancer Care (Engl). 2009 Sep;18(5):492-9. doi: 10.1111/j.1365-2354.2008.00984.x.

    PubMed 19453695

  • Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.

    PubMed 12049862

  • Koo JE, Kim JH, Lim YS, Park SJ, Won HJ, Sung KB, Suh DJ. Combination of transarterial chemoembolization and three-dimensional conformal radiotherapy for hepatocellular carcinoma with inferior vena cava tumor thrombus. Int J Radiat Oncol Biol Phys. 2010 Sep 1;78(1):180-7. doi: 10.1016/j.ijrobp.2009.07.1730. Epub 2009 Nov 18.

    PubMed 19926229

  • Shiomi H, Naka S, Sato K, Demura K, Murakami K, Shimizu T, Morikawa S, Kurumi Y, Tani T. Thoracoscopy-assisted magnetic resonance guided microwave coagulation therapy for hepatic tumors. Am J Surg. 2008 Jun;195(6):854-60. doi: 10.1016/j.amjsurg.2007.08.056. Epub 2008 Mar 26.

    PubMed 18355796

  • Liu C, Liang P, Liu F, Wang Y, Li X, Han Z, Liu C. MWA combined with TACE as a combined therapy for unresectable large-sized hepotocellular carcinoma. Int J Hyperthermia. 2011;27(7):654-62. doi: 10.3109/02656736.2011.605099. Epub 2011 Oct 3.

    PubMed 21966941

  • Gillams A. Tumour ablation: current role in the liver, kidney, lung and bone. Cancer Imaging. 2008 Oct 4;8 Spec No A(Spec Iss A):S1-5. doi: 10.1102/1470-7330.2008.9001.

    PubMed 18852074

  • Livraghi T, Goldberg SN, Lazzaroni S, Meloni F, Solbiati L, Gazelle GS. Small hepatocellular carcinoma: treatment with radio-frequency ablation versus ethanol injection. Radiology. 1999 Mar;210(3):655-61. doi: 10.1148/radiology.210.3.r99fe40655.

    PubMed 10207464

  • Goldberg SN, Charboneau JW, Dodd GD 3rd, Dupuy DE, Gervais DA, Gillams AR, Kane RA, Lee FT Jr, Livraghi T, McGahan JP, Rhim H, Silverman SG, Solbiati L, Vogl TJ, Wood BJ; International Working Group on Image-Guided Tumor Ablation. Image-guided tumor ablation: proposal for standardization of terms and reporting criteria. Radiology. 2003 Aug;228(2):335-45. doi: 10.1148/radiol.2282021787.

    PubMed 12893895

  • Gillams AR. Image guided tumour ablation. Cancer Imaging. 2005 Sep 21;5(1):103-9. doi: 10.1102/1470-7330.2005.0015.

    PubMed 16305946

  • Ito A, Shinkai M, Honda H, Yoshikawa K, Saga S, Wakabayashi T, Yoshida J, Kobayashi T. Heat shock protein 70 expression induces antitumor immunity during intracellular hyperthermia using magnetite nanoparticles. Cancer Immunol Immunother. 2003 Feb;52(2):80-8. doi: 10.1007/s00262-002-0335-x. Epub 2003 Jan 29.

    PubMed 12594571

  • Dong BW, Zhang J, Liang P, Yu XL, Su L, Yu DJ, Ji XL, Yu G. Sequential pathological and immunologic analysis of percutaneous microwave coagulation therapy of hepatocellular carcinoma. Int J Hyperthermia. 2003 Mar-Apr;19(2):119-33. doi: 10.1080/0265673021000017154.

    PubMed 12623635

  • Xu LF, Sun HL, Chen YT, Ni JY, Chen D, Luo JH, Zhou JX, Hu RM, Tan QY. Large primary hepatocellular carcinoma: transarterial chemoembolization monotherapy versus combined transarterial chemoembolization-percutaneous microwave coagulation therapy. J Gastroenterol Hepatol. 2013 Mar;28(3):456-63. doi: 10.1111/jgh.12088.

    PubMed 23216261

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Thermal Ablation, EADM and Ultra-fluid lipiodol in people with Carcinoma, Hepatocellular, run by Shanghai Zhongshan Hospital 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 11 inclusion and 12 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 18 Oct 2016. 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.

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?

Results are not available in the source record.

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

Contact Jianhua Wang, MD (+8613611759557, wang.jianhua@zs-hospital.sh.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: From the date of randomization until the date of death from any cause, assessed up to 26 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 NCT02630108, which also lists 30 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 18 Oct 2016; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in