TATE Versus TACE in Intermediate Stage HCC

NCT ID: NCT03145558

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-05
• Study Completion Date: 2024-06-30

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.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Trans-Arterial Tirapazamine Embolization (TATE)

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

Group Type: EXPERIMENTAL

Tirapazamine

Intervention Type: DRUG

Replacing the standard chemotherapy agent doxorubicin used in TACE with tirapazamine

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.

Group Type: ACTIVE_COMPARATOR

Doxorubicin

Intervention Type: DRUG

Standard of care for TACE

Interventions

Tirapazamine

Replacing the standard chemotherapy agent doxorubicin used in TACE with tirapazamine

Intervention Type: DRUG

Doxorubicin

Standard of care for TACE

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teclison Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadine Abi-Jaoudeh

Role: STUDY_CHAIR

University of California, Irvine

Locations

University of California, Irvine

Irvine, California, United States

Oregon Health Science University

Portland, Oregon, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

LT-006

Identifier Type: -

Identifier Source: org_study_id