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Hepatocellular CarcinomaPhase 3NCT01869088

TACE Plus Recombinant Human Adenovirus for Hepatocellular Carcinoma

A Phase 3 study testing Recombinant Human Adenovirus Type 5 Injection and Transartery Chemoembolization in people with Hepatocellular Carcinoma, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery or local ablative therapy. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Recombinant Human Adenovirus Type 5 Injection and Transartery Chemoembolization
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
1 siteChina
Study dates
Jan 2013to Jan 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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients newly diagnosed as HCC according to European Association for Study of the Liver criteria.
  • BCLC stage A or B
  • Child-Pugh class A or B (Child-Pugh score 7)
  • ECOG performance status of 0
  • Patients must have at least one tumor lesion that meets both of the following criteria:
  • The lesion can be accurately measured in at least one dimension according to RECIST criteria
Show all 12Show fewer
  • The lesion has not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
  • Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) to non-target lesions are eligible
  • Local therapy must have been completed at least 4 weeks prior to baseline scan.
  • Haematology:Absolute neutrophil count (ANC) > 1 x 109/L, Platelet count > 40 x 109/L, Haemoglobin > 9 g/dL (may be transfused to maintain or exceed this level) Prothrombin time international normalized ratio < 1.5
  • Biochemistry:Total bilirubin < 2 mg/dL Serum creatinine < 1.5 x the upper limit of normal
  • Ability to understand the protocol and to agree to and sign a written informed consent document

Who cannot join

  • Tumor factors
  • Presence of extrahepatic metastasis
  • Predominantly infiltrative lesion
  • Diffuse tumor morphology with extensive lesions involving both lobes.
  • Vascular complications
  • Hepatic artery thrombosis, or
Show all 28Show fewer
  • Partial or complete thrombosis of the main portal vein, or
  • Tumor invasion of portal branch of contralateral lobe, or
  • Hepatic vein tumor thrombus, or
  • Significant arterioportal shunt not amenable to shunt blockage
  • Liver function
  • Advanced liver disease: ascites, hepatic encephalopathy
  • Patients with clinically significant gastrointestinal bleeding within the 30 days prior to study entry.
  • Others
  • Renal failure requiring hemo- or peritoneal dialysis
  • Pregnant or lactating women.
  • Active sepsis or bleeding.
  • Hypersensitivity to intravenous contrast agents.
  • The patient has received prior treatment for HCC target lesion.
  • History of cardiac disease
  • Congestive heart failure > NYHA class 2; active coronary artery disease
  • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
  • Hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg despite optimal medical management.
  • Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months.
  • The patient is, in the opinion of the investigator, unable and / or unwilling to comply with treatment and study instructions.
  • Substance abuse (current), psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • Any active clinically serious infections (> grade 2 NCI-CTCAE ver 3.0)
  • HIV infection or AIDS-related illness or serious acute or chronic illness (based on medical history)

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong

Other trials in China

About this study

Official title: Phase Ⅲ Trial of Transcatheter Arterial Chemoembolization(TACE) Plus Recombinant Human Adenovirus Type 5 Injection for Unresectable Hepatocellular Carcinoma (HCC)

The purpose of this study is to determine if TACE plus Recombinant Human Adenovirus Type 5 Injection will improve outcome in patients with advanced hepatocellular carcinoma (HCC) not amenable to surgery or local ablative therapy.

Read the detailed description

Transarterial chemoembolization (TACE) is currently one of the mainstays of palliative treatments worldwide for patients with unresectable Hepatocellular Carcinoma(HCC).However, the long term outcomes were generally poor for HCC patients treated with TACE. Recombinant Human Adenovirus Type 5, an E1B gene deleted adenovirus, is known to have a significant antitumor activity. In addition, local injection of recombinant human adenovirus type 5 can enhance the effect of antitumor therapies (chemotherapy and radiotherapy). The hypothesis is that patients with unresectable HCC may benefit from recombinant human adenovirus type 5 in combination with TACE.

Being tested
Recombinant Human Adenovirus Type 5 Injection, Transartery Chemoembolization
Keywords
TACE, Carcinoma,Hepatocellular, Liver Neoplasms, overall survival, Recombinant Human Adenovirus Type 5 Injection
Medical subject headings
Carcinoma, Hepatocellular, Liver Neoplasms

What participants receive

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

  • Recombinant Human Adenovirus Type 5 InjectionDrug

    After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0*1011vp：0.5ml*3） will be first infused through the target artery

  • Transartery ChemoembolizationProcedure or surgery

    Transartery chemoembolization with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.

Study groups in NCT01869088
Study groupRoleWhat they receive
TACE OnlyActive comparatorTACE with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.
Receives: Procedure: Transartery Chemoembolization
TACE Plus AdenovirusExperimentalAfter identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0*1011vp：0.5ml*3） will be first infused through the target artery of HCC patient and followed with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg) and lipiodol emulsion or/and polyvinyl alcohol particles(dependent on the tumor size) Procedure: TACE (Transcatheter arterial chemoembolization)
Receives: Drug: Recombinant Human Adenovirus Type 5 Injection; Procedure: Transartery Chemoembolization

What is being measured

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

  1. Overall survival time

    Measured: 3 years

Secondary outcomes (2)

  1. Number of adverse events

    Number of adverse events, and number of patients who developed adverse event. Postoperative adverse events were graded based on the Common Terminology Criteria for Adverse Events ( CTCAE )

    Measured: 30 days

  2. Tumor response

    Tumor response based on modified RECIST

    Measured: 12 weeks

Timeline

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

  1. First posted5 Jun 2013 (estimated)
  2. Study startJan 2013
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 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
266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01869088
Sponsor's protocol ID
HCC-120402
Status last verified
Mar 2017
First submitted
16 Feb 2013
Last updated
16 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Vogl TJ, Trapp M, Schroeder H, Mack M, Schuster A, Schmitt J, Neuhaus P, Felix R. Transarterial chemoembolization for hepatocellular carcinoma: volumetric and morphologic CT criteria for assessment of prognosis and therapeutic success-results from a liver transplantation center. Radiology. 2000 Feb;214(2):349-57. doi: 10.1148/radiology.214.2.r00fe06349.

    PubMed 10671580

  • Ono Y, Yoshimasu T, Ashikaga R, Inoue M, Shindou H, Fuji K, Araki Y, Nishimura Y. Long-term results of lipiodol-transcatheter arterial embolization with cisplatin or doxorubicin for unresectable hepatocellular carcinoma. Am J Clin Oncol. 2000 Dec;23(6):564-8. doi: 10.1097/00000421-200012000-00006.

    PubMed 11202797

  • Geschwind JF, Ramsey DE, Cleffken B, van der Wal BC, Kobeiter H, Juluru K, Hartnell GG, Choti MA. Transcatheter arterial chemoembolization of liver tumors: effects of embolization protocol on injectable volume of chemotherapy and subsequent arterial patency. Cardiovasc Intervent Radiol. 2003 Mar-Apr;26(2):111-7. doi: 10.1007/s00270-002-2524-6. Epub 2003 Mar 6.

    PubMed 12616414

  • Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van Glabbeke M, van Oosterom AT, Christian MC, Gwyther SG. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst. 2000 Feb 2;92(3):205-16. doi: 10.1093/jnci/92.3.205.

    PubMed 10655437

  • Bruix J, Llovet JM, Castells A, Montana X, Bru C, Ayuso MC, Vilana R, Rodes J. Transarterial embolization versus symptomatic treatment in patients with advanced hepatocellular carcinoma: results of a randomized, controlled trial in a single institution. Hepatology. 1998 Jun;27(6):1578-83. doi: 10.1002/hep.510270617.

    PubMed 9620330

  • Camma C, Schepis F, Orlando A, Albanese M, Shahied L, Trevisani F, Andreone P, Craxi A, Cottone M. Transarterial chemoembolization for unresectable hepatocellular carcinoma: meta-analysis of randomized controlled trials. Radiology. 2002 Jul;224(1):47-54. doi: 10.1148/radiol.2241011262.

    PubMed 12091661

  • Lee KH, Liapi E, Vossen JA, Buijs M, Ventura VP, Georgiades C, Hong K, Kamel I, Torbenson MS, Geschwind JF. Distribution of iron oxide-containing Embosphere particles after transcatheter arterial embolization in an animal model of liver cancer: evaluation with MR imaging and implication for therapy. J Vasc Interv Radiol. 2008 Oct;19(10):1490-6. doi: 10.1016/j.jvir.2008.06.008. Epub 2008 Aug 27.

    PubMed 18755602

  • Higashi S, Tabata N, Kondo KH, Maeda Y, Shimizu M, Nakashima T, Setoguchi T. Size of lipid microdroplets effects results of hepatic arterial chemotherapy with an anticancer agent in water-in-oil-in-water emulsion to hepatocellular carcinoma. J Pharmacol Exp Ther. 1999 May;289(2):816-9.

    PubMed 10215657

  • Caturelli E, Siena DA, Fusilli S, Villani MR, Schiavone G, Nardella M, Balzano S, Florio F. Transcatheter arterial chemoembolization for hepatocellular carcinoma in patients with cirrhosis: evaluation of damage to nontumorous liver tissue-long-term prospective study. Radiology. 2000 Apr;215(1):123-8. doi: 10.1148/radiology.215.1.r00ap21123.

    PubMed 10751477

  • Llovet JM, Bustamante J, Castells A, Vilana R, Ayuso Mdel C, Sala M, Bru C, Rodes J, Bruix J. Natural history of untreated nonsurgical hepatocellular carcinoma: rationale for the design and evaluation of therapeutic trials. Hepatology. 1999 Jan;29(1):62-7. doi: 10.1002/hep.510290145.

    PubMed 9862851

  • Lo CM, Ngan H, Tso WK, Liu CL, Lam CM, Poon RT, Fan ST, Wong J. Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma. Hepatology. 2002 May;35(5):1164-71. doi: 10.1053/jhep.2002.33156.

    PubMed 11981766

  • Lau WY, Yu SC, Lai EC, Leung TW. Transarterial chemoembolization for hepatocellular carcinoma. J Am Coll Surg. 2006 Jan;202(1):155-68. doi: 10.1016/j.jamcollsurg.2005.06.263. Epub 2005 Oct 19. No abstract available.

    PubMed 16377509

  • Lee KH, Liapi E, Ventura VP, Buijs M, Vossen JA, Vali M, Geschwind JF. Evaluation of different calibrated spherical polyvinyl alcohol microspheres in transcatheter arterial chemoembolization: VX2 tumor model in rabbit liver. J Vasc Interv Radiol. 2008 Jul;19(7):1065-9. doi: 10.1016/j.jvir.2008.02.023. Epub 2008 Apr 10.

    PubMed 18589321

  • 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

  • Groupe d'Etude et de Traitement du Carcinome Hepatocellulaire. A comparison of lipiodol chemoembolization and conservative treatment for unresectable hepatocellular carcinoma. N Engl J Med. 1995 May 11;332(19):1256-61. doi: 10.1056/NEJM199505113321903.

    PubMed 7708069

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Recombinant Human Adenovirus Type 5 Injection and Transartery Chemoembolization in people with Hepatocellular Carcinoma, 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 12 inclusion and 28 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 16 Mar 2017. 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?

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 (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 NCT01869088, which also lists 32 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 16 Mar 2017.

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