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TerminatedNCT03145558TATEUpdated Nov 22, 2024

TATE Versus TACE in Intermediate Stage HCC

A Phase 2 interventional study of Tirapazamine and Doxorubicin in Carcinoma, Hepatocellular, sponsored by Teclison Ltd.. Terminated at 3 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-22.

Sponsored by Teclison Ltd. · Phase 2, Interventional, and Treatment

Why this study was terminated
Landscape changed and the study population is no longer suitable for the study treatment.
Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Carcinoma, Hepatocellular

Keywords

  • Tirapazamine, embolization, TACE, Hepatocellular carcinoma
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Trans-Arterial Tirapazamine Embolization (TATE)

    Patients will receive a fixed dose of Tirapazamine combined with embolization using Lipiodol and Gelfoam.

    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.

    Drug: Doxorubicin

Interventions

  • DrugTirapazamine

    Replacing the standard chemotherapy agent doxorubicin used in TACE with tirapazamine

  • DrugDoxorubicin

    Standard of care for TACE

05

What researchers measure

Primary outcomes

  1. Progression Free Survival

    mRECIST criteria

    Time frame: within 2 years

Secondary outcomes

  1. Overall survival

    From randomization to death

    Time frame: 3 years

  2. Complete Response rate

    CR rate based on mRECIST criteria

    Time frame: 2 years

  3. Time to Embolization Failure

    From randomization to stage progression

    Time frame: 1 year

  4. Duration of CR

    From randomization to recurrence in those patients who achieved CR

    Time frame: 1 year

Other outcomes

  1. Local recurrence rate

    Recurrence rate in the embolized lesion

    Time frame: 1 year

  2. Time to local recurrence

    From randomization to local recurrence

    Time frame: 2 years

06

Study locations

3 sites
  • University of California, Irvine
    Irvine, California 92868, United States
  • Oregon Health Science University
    Portland, Oregon 97239, United States
  • Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03145558
Lead sponsor
Teclison Ltd.
Responsible party
Sponsor
First posted
May 9, 2017
Start date
Dec 5, 2017
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Nov 22, 2024

Study contacts

Nadine Abi-Jaoudeh
study chair · University of California, Irvine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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