Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
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ClinicalTrials.gov Identifier: NCT02174549 |
Recruitment Status :
Active, not recruiting
First Posted : June 25, 2014
Last Update Posted : May 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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Hepatocellular Carcinoma Gastrointestinal Cancer Metastatic Neuroendocrine Tumors | Drug: Tirapazamine Procedure: Transarterial embolization (TAE) | Phase 1 Phase 2 |
The study is a 3+3 design for dose escalation. Each cohort will have 3-6 patients based on tolerability. Patients will receive escalated doses of tirapazamine until maximally tolerated dose. Embolization is performed per standard practice using Lipiodol and Gelfoam under X-ray guidance. Once a suitable dose is determined, an expansion cohort of 15 patients will be treated with the recommended phase 2 dose to determine preliminary efficacy. Expansion cohorts include (1) hepatocellular carcinoma, (2) metastatic solid tumors with liver metastasis, and (3) neuroendocrine tumor. Adverse events are evaluated by CTCAE vs. 5.0 and efficacy is evaluated by MRI using modified RECIST criteria and RECIST criteria.
The dose escalation part has been completed. Only the third cohort or neuroendocrine tumor remains active for future patient enrollment.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Open label, dose escalation 3+3 design; 3 expansion cohorts: hepatocellular carcinoma, advanced solid tumors and neuroendocrine tumor. |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer |
Study Start Date : | September 2014 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2023 |

Arm | Intervention/treatment |
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Experimental: Tirapazamine
Administration with dose escalated tirapazamine before embolization until maximally tolerated dose achieved.
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Drug: Tirapazamine
Intra-arterial injection into the tumor feeding artery Procedure: Transarterial embolization (TAE) Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
Other Name: Lipiodol and Gelfoam as the standard embolizing agents. |
- determine the recommended phase 2 dose [ Time Frame: 2 years ]future dose used for randomzied trials
- Complete Response (CR) rate [ Time Frame: 2 years ]mRECIST based on mRECIST
- Duration of response [ Time Frame: 2 years ]From randomization to progression
- Area under the plasma concentration versus time curve (AUC) [ Time Frame: 2 years ]PK parameter

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- Confirmed diagnosis of HCC > 10 mm with a characteristic 4-phase CT or dynamic contrast enhanced MRI finding showing intense arterial uptake followed by "washout" of contrast in the venous-delayed phases per American Association for the Study of Liver Disease (AASLD) criteria.
- Patients between ages 20 and 80
- Patients with single or multiple (2-4 nodules) HCC who are unsuitable or unwilling for surgical resection or RFA. The largest tumor nodule should be less than 10 cm in the largest diameter. The total volume of tumor cannot exceed 50% of liver; or patients with liver metastatic gastrointestinal cancer, including neuroendocrine tumor
- Patients are candidates for TAE or Transarterial ChemoEmbolization (TACE). No tumor invasion to portal vein or thrombosis in portal vein.
- ECOG score 0-1 with no known cardiac, pulmonary or renal dysfunction
- Child-Pugh score group A or B7 liver functional score
- Prior local therapies such as surgical resection, radiofrequency ablation, or alcohol injection are allowed as long as tumor progresses from the prior treatment and the patients are still candidates for TAE. All prior therapy must be at least 4 weeks prior to enrollment and free from treatment-related toxicity.
- No TAE/TACE in the past
- Patients have normal organ function: ANC ≥ 1000 /µL, Hemoglobin ≥ 9 gm/dL, Platelets ≥ 50,000 /µL, Creatinine ≤ 2 mg/dL, AST and ALT < 5 X upper normal limit of the current institution; bilirubin ≤ 3.0 mg/dL, PT prolongation no more than 4 sec above upper limit of normal.
For the expansion cohort of neuroendocrine tumor or metastatic solid tumor with liver involvement
- Unresectable, locally advanced or metastatic, well differentiated (low or intermediate grade), neuroendocrine tumors (NET).
- Metastatic solid tumor with liver involvement.

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): NCT02174549
United States, California | |
University of California Irvine Medical Center | |
Orange, California, United States, 92868 | |
Univ. of California, San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Nadine Abi-Jaoudeh, MD | Univ. of California, Irvine |
Responsible Party: | Teclison Ltd. |
ClinicalTrials.gov Identifier: | NCT02174549 |
Other Study ID Numbers: |
LT001 |
First Posted: | June 25, 2014 Key Record Dates |
Last Update Posted: | May 2, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Hypoxia Embolization Tirapazamine |
Liver Neoplasms Neuroendocrine Tumors Gastrointestinal Neoplasms Neoplasms by Histologic Type Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Liver Diseases Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Gastrointestinal Diseases Tirapazamine Antineoplastic Agents |