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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.

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Tirapazamine Drug: Doxorubicin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
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
Official Title: TATE Versus TACE, an Open-label Randomized Study Comparing TransArterial Tirapazamine Embolization Versus TransArterial ChemoEmbolization in Intermediate Stage Hepatocellular Carcinoma
Actual Study Start Date : December 5, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Doxorubicin

Arm Intervention/treatment
Experimental: Trans-Arterial Tirapazamine Embolization (TATE)
Patients will receive a fixed dose of Tirapazamine combined with embolization using Lipiodol and Gelfoam.
Drug: Tirapazamine
Replacing the standard chemotherapy agent doxorubicin used in TACE with 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.
Drug: Doxorubicin
Standard of care for TACE




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: within 2 years ]
    mRECIST criteria


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
    From randomization to death

  2. Complete Response rate [ Time Frame: 2 years ]
    CR rate based on mRECIST criteria

  3. Time to Embolization Failure [ Time Frame: 1 year ]
    From randomization to stage progression

  4. Duration of CR [ Time Frame: 1 year ]
    From randomization to recurrence in those patients who achieved CR


Other Outcome Measures:
  1. Local recurrence rate [ Time Frame: 1 year ]
    Recurrence rate in the embolized lesion

  2. Time to local recurrence [ Time Frame: 2 years ]
    From randomization to local recurrence



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145558


Locations
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United States, California
University of California, Irvine
Irvine, California, United States, 92868
United States, Oregon
Oregon Health Science University
Portland, Oregon, United States, 97239
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Teclison Ltd.
Investigators
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Principal Investigator: Nadine Abi-Jaoudeh, MD University of California, Irvine
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Responsible Party: Teclison Ltd.
ClinicalTrials.gov Identifier: NCT03145558    
Other Study ID Numbers: LT-006
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teclison Ltd.:
Tirapazamine, embolization, TACE, Hepatocellular carcinoma
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Tirapazamine
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action