TATE Versus TACE in Intermediate Stage HCC



Status:Recruiting
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 85
Updated:5/4/2018
Start Date:December 5, 2017
End Date:October 31, 2021
Contact:Linta GARCIA
Email:linta_garcia@teclison.com
Phone:973-744-2342

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TATE Versus TACE, an Open-label Randomized Study Comparing TransArterial Tirapazamine Embolization Versus TransArterial ChemoEmbolization in Intermediate Stage Hepatocellular Carcinoma

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.

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.

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.
We found this trial at
3
sites
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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Milwaukee, WI
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Irvine, California 92697
949-824-5011
Phone: 714-456-7687
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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Irvine, CA
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