TATE Versus TACE in Intermediate Stage HCC

NCT03145558 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: LT-006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Carcinoma, Hepatocellular

Keywords

Tirapazamine, embolization, TACE, Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  mRECIST criteria

  within 2 years

Secondary Outcomes (4)

• Overall survival

  3 years

• Complete Response rate

  2 years

• Time to Embolization Failure

  1 year

• Duration of CR

  1 year

Other Outcomes (2)

• Local recurrence rate

  1 year

• Time to local recurrence

  2 years

Study Arms (2)

Trans-Arterial Tirapazamine Embolization (TATE)

EXPERIMENTAL

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

Drug: Tirapazamine

Trans-Arterial ChemoEmbolization (TACE)

ACTIVE COMPARATOR

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

Tirapazamine DRUG

Replacing the standard chemotherapy agent doxorubicin used in TACE with tirapazamine

Trans-Arterial Tirapazamine Embolization (TATE)

Doxorubicin DRUG

Standard of care for TACE

Trans-Arterial ChemoEmbolization (TACE)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients who have had a liver transplantation.
• 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.
• Patients who have any clinical evidence of hypoxia with O2 saturation less than 92% on room air.
• 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.
• Patients with poorly controlled HBV infection.
• Patients on interferon treatment need to have at least 2-week washout period from Day 1.
• Patients with major gastrointestinal bleeding in the prior 2 months of enrollment or known diagnosis of cancer other than HCC.
• Pregnant or lactating women.

Sponsors & Collaborators

• Teclison Ltd.: lead

Study Sites (3)

University of California, Irvine

Irvine, California, 92868, United States

Location

Oregon Health Science University

Portland, Oregon, 97239, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Tirapazamine; Doxorubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Nadine Abi-Jaoudeh

  University of California, Irvine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Central radiology reviewers are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 1:1 randomization, open label with central radiological review

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 9, 2017
• Study Start: December 5, 2017
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)