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TATE Versus TACE in Intermediate Stage HCC (TATE)

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ClinicalTrials.gov Identifier: NCT03145558
Recruitment Status : Active, not recruiting
First Posted : May 9, 2017
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
Teclison Ltd.

Tracking Information
First Submitted Date  ICMJE May 3, 2017
First Posted Date  ICMJE May 9, 2017
Last Update Posted Date January 7, 2021
Actual Study Start Date  ICMJE December 5, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
Progression Free Survival [ Time Frame: within 2 years ]
mRECIST criteria
Original Primary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
Progression Free Survival [ Time Frame: within 2 years ]
RECIST criteria
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • Overall survival [ Time Frame: 3 years ]
    From randomization to death
  • Complete Response rate [ Time Frame: 2 years ]
    CR rate based on mRECIST criteria
  • Time to Embolization Failure [ Time Frame: 1 year ]
    From randomization to stage progression
  • Duration of CR [ Time Frame: 1 year ]
    From randomization to recurrence in those patients who achieved CR
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2017)
  • Overall survival [ Time Frame: within 3 years ]
    Kaplan Meier curve
  • Complete Response rate [ Time Frame: 2 years ]
    modified RECIST criteria
Current Other Pre-specified Outcome Measures
 (submitted: November 13, 2017)
  • Local recurrence rate [ Time Frame: 1 year ]
    Recurrence rate in the embolized lesion
  • Time to local recurrence [ Time Frame: 2 years ]
    From randomization to local recurrence
Original Other Pre-specified Outcome Measures
 (submitted: May 4, 2017)
  • Biomarker endpoints [ Time Frame: the first 30 days after treatment for each patient ]
    angiogenic markers such as VEGF and others
  • transplant eligibility [ Time Frame: 2 years ]
    downstaged to fulfil the Milan criteria
 
Descriptive Information
Brief Title  ICMJE TATE Versus TACE in Intermediate Stage HCC
Official Title  ICMJE TATE Versus TACE, an Open-label Randomized Study Comparing TransArterial Tirapazamine Embolization Versus TransArterial ChemoEmbolization in Intermediate Stage Hepatocellular Carcinoma
Brief Summary An open label randomized study to compare TATE versus TACE in patients with intermediate stage Hepatocellular carcinoma who are not suitable for surgical resection or radiofrequency ablation. The primary endpoint is Progression Free Survival. Secondary endpoints including CR rate, Time to embolization failure, Duration of CR, OS, ORR, local control rate, time to local recurrence and duration to local recurrence. The study treatment is to compare Tirapazamine versus doxorubicin when combined with trans-arterial embolization. Study plans to enroll 134 patients in 1:1 randomization for TATE or TACE. MRI will be used to assess efficacy using a central radiological review for the final analysis.
Detailed Description Trans-arterial chemoembolization (TACE) is a standard care of intermediate stage Hepatocellular carcinoma (HCC) for 40 years without much improvement in efficacy. The key reason for lack of progress is that chemotherapy agents are not effective in hypoxia and cancer stem cells are induced under hypoxia. Tirapazamine, a hypoxia activated agent, can potential solve these two problems. This open label randomized trial will be conducted in HCC patients who are in intermediate stage and naive to embolization, Child Pugh up to B7 and with normal organ functions. Patients will be randomized 1:1 to receive TATE (trans-arterial tirapazamine embolization) or conventional TACE. The goal of treatment aims to achieve CR by mRECIST for every patient. If there is evidence of viable lesion, patients should be treated again. All patients are followed by contrast MRI scans every 2 months in the first year and every 3 months afterwards until patients have evidence of progression and no longer considered suitable for TATE/TACE. Survival will be followed for 3 years. Total sample size will be 134 patients with the total study duration for 3 years.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
1:1 randomization, open label with central radiological review
Masking: Single (Outcomes Assessor)
Masking Description:
Central radiology reviewers are blinded.
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE
  • Drug: Tirapazamine
    Replacing the standard chemotherapy agent doxorubicin used in TACE with tirapazamine
  • Drug: Doxorubicin
    Standard of care for TACE
Study Arms  ICMJE
  • Experimental: Trans-Arterial Tirapazamine Embolization (TATE)
    Patients will receive a fixed dose of Tirapazamine combined with embolization using Lipiodol and Gelfoam.
    Intervention: Drug: Tirapazamine
  • Active Comparator: Trans-Arterial ChemoEmbolization (TACE)
    Patients will receive a mixture of doxorubicin and Lipiodol into the tumor feeding artery followed by injection of Gelfoam to induce embolization per standard procedure.
    Intervention: Drug: Doxorubicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
134
Original Estimated Enrollment  ICMJE
 (submitted: May 4, 2017)
114
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  1. Confirmed diagnosis of HCC by imaging criteria per American Association for the Study of Liver Diseases (AASLD) criteria.
  2. Patients with single or multiple HCC who are unsuitable for surgical resection or RFA, but suitable for embolization.
  3. ECOG score 0-1. Child-Pugh score up to B7.
  4. Patients should have measurable tumor lesion(s) by contrast MRI.
  5. Patients have adequate normal organ function and suitable laboratory criteria.
  6. Men and women of child-bearing age need to commit to using two levels of contraception simultaneously to avoid pregnancy.

Exclusion Criteria:

  1. Patients who have had a liver transplantation.
  2. Patients who have uncontrolled major medical problems such as cardiac, pulmonary (COPD requiring constant oxygen), renal (creatinine over 2.0) diseases, active infectious diseases (except chronic Hepatitis B or C), or non-healing ulceration.
  3. Patients who have any clinical evidence of hypoxia with O2 saturation less than 92% on room air.
  4. Patients with evidence of arterial insufficiency or microangiopathy in any organ due to any reason, which could lead to distal extremity hypoxia, as evidenced by any gangrenous change in distal limbs or requiring resection for this reason.
  5. Patients with poorly controlled HBV infection.
  6. Patients on interferon treatment need to have at least 2-week washout period from Day 1.
  7. Patients with major gastrointestinal bleeding in the prior 2 months of enrollment or known diagnosis of cancer other than HCC.
  8. Pregnant or lactating women.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03145558
Other Study ID Numbers  ICMJE LT-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Teclison Ltd.
Study Sponsor  ICMJE Teclison Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nadine Abi-Jaoudeh, MD University of California, Irvine
PRS Account Teclison Ltd.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP