Hepatocellular CarcinomaPhase 1/2NCT02174549
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
A Phase 1/2 study testing Tirapazamine and Conventional Transarterial Embolization (TAE) in people with Hepatocellular Carcinoma and Gastrointestinal Cancer Metastatic, run by Teclison Ltd. at 2 sites in United States.
Trial summary
This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4 nodules are eligible. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Hepatocellular Carcinoma, Gastrointestinal Cancer Metastatic, Neuroendocrine Tumors
- What is being tested?
- Tirapazamine and Conventional Transarterial Embolization (TAE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to 30 Sep 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with well-differentiated NET and liver-dominant metastatic disease with intrahepatic disease progression, regardless of primary tumor origin or tumor functional status. Patients may have extrahepatic lesions as long as the majority of the disease burden is intrahepatic.
- No limitation in hepatic lesion tumor size or number but the total volume of liver tumors cannot exceed 50% of the liver volume.
- Patients are allowed to have prior US Food and Drug Administration (FDA)-approved treatments, including systemic therapies, surgery, ablation, or transarterial therapies for the metastatic NET.
- Age 20 or higher, ECOG functional status 0-1, and with no known major cardiac, pulmonary, or renal dysfunction.
- Are candidates for TAE or TACE and without portal vein occlusion per treating interventional radiologists.
- ANC no less than 1000 /μL. Hemoglobin ≥ 9 gm/dL. Platelets no less than 50,000 /μL. Creatinine no more than 2.0 mg/dL. AST, ALT no more than 5X upper limit of normal. Bilirubin no more than 2.5 mg/dl. PT prolongation ≤ 4 sec above upper limit of normal.
- Woman of child-bearing potential (WOCBP) should use highly effective contraception during trial participation and for 6 months after the last dose of tirapazamine and men who are partners with WOCBP should use highly effective contraception, including barrier contraception, during trial participation and for 3 months after the last dose of tirapazamine.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ray Lee contact
United States2 sites, 2 recruiting
- Recruiting
Stanford University
Palo Alto, California, 94305
Mikayla Easterling, 650-724-3698, maeast@stanford.edu
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Veronica Faris, 215-573-9765, veronica.faris@pennmedicine.upenn.edu
About this study
Official title: Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer
This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4 nodules are eligible. Tirapazamine will be given by intra-arterial injection before embolization. Treatment effect is evaluated by MRI based on mRECIST criteria. Repeat treatment is necessary only if disease progression. Dose escalation cohort has been completed. Expansion cohort is open for metastatic liver dominant neuroendocrine tumor.
Read the detailed description
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.
- Being tested
- Tirapazamine, Conventional Transarterial Embolization (TAE)
- Keywords
- Hypoxia, Embolization, Tirapazamine
- Medical subject headings
- Carcinoma, Hepatocellular, Neuroendocrine Tumors, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirapazamineDrug
Intra-arterial injection into the tumor feeding artery
Conventional Transarterial Embolization (TAE)Procedure or surgery
Also called TAE conducted with Lipiodol and Surgifoam as the embolizing agents.
Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
| Study group | Role | What they receive |
|---|---|---|
| Tirapazamine | Experimental | Intra-arterial administration with tirapazamine before embolization to evaluate the response in metastatic liver lesions of NET Receives: Drug: Tirapazamine; Procedure: Conventional Transarterial Embolization (TAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response rate (ORR) by RECIST
Overall Response Rate by RECIST criteria
Measured: 2 years
Secondary outcomes (2)
Overall Response Rate
Overall Response Rate by mRECIST criteria
Measured: 2 years
Duration of Response
Duration of Response by RECIST and mRECIST
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startSep 2014
- Primary completion31 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, dose escalation 3+3 design completed; now only for expansion cohort in neuroendocrine tumor.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teclison Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Soulen, MD, Principal investigator, Univ. of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02174549
- Sponsor's protocol ID
- LT001
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2014
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Abi-Jaoudeh N, Dayyani F, Chen PJ, Fernando D, Fidelman N, Javan H, Liang PC, Hwang JI, Imagawa DK. Phase I Trial on Arterial Embolization with Hypoxia Activated Tirapazamine for Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2021 May 17;8:421-434. doi: 10.2147/JHC.S304275. eCollection 2021.
PubMed 34041204
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose-Escalating Study of Combining Intravenous Tirapazamine and Transarterial Embolization (TAE) in Liver Cancer
- ClinicalTrials.gov ID
- NCT02174549
- Acronym / sponsor ID
- LT001
- Keywords
- Hypoxia, Embolization, Tirapazamine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Teclison Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase 1 study is to determine the optimal dose and tolerability of a hypoxia-activating agent, tirapazamine, when it is combined with embolization in liver cancer. Liver cancer patients who are Child-Pugh score A, suitable for embolization with tumor no more than 4 nodules are eligible. Tirapazamine will be given by intra-arterial injection before embolization. Treatment effect is evaluated by MRI based on mRECIST criteria. Repeat treatment is necessary only if disease progression. Dose escalation cohort has been completed. Expansion cohort is open for metastatic liver dominant neuroendocrine tumor.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, dose escalation 3+3 design completed; now only for expansion cohort in neuroendocrine tumor.
| Arm | Type | Receives |
|---|---|---|
| Tirapazamine | Experimental | Drug: Tirapazamine, Procedure: Conventional Transarterial Embolization (TAE)Intra-arterial administration with tirapazamine before embolization to evaluate the response in metastatic liver lesions of NET |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with well-differentiated NET and liver-dominant metastatic disease with intrahepatic disease progression, regardless of primary tumor origin or tumor functional status. Patients may have extrahepatic lesions as long as the majority of the disease burden is intrahepatic.
- No limitation in hepatic lesion tumor size or number but the total volume of liver tumors cannot exceed 50% of the liver volume.
- Patients are allowed to have prior US Food and Drug Administration (FDA)-approved treatments, including systemic therapies, surgery, ablation, or transarterial therapies for the metastatic NET.
- Age 20 or higher, ECOG functional status 0-1, and with no known major cardiac, pulmonary, or renal dysfunction.
- Are candidates for TAE or TACE and without portal vein occlusion per treating interventional radiologists.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirapazamineIntra-arterial injection into the tumor feeding artery | Drug | Tirapazamine |
| Conventional Transarterial Embolization (TAE)Also: TAE conducted with Lipiodol and Surgifoam as the embolizing agents.Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia | Procedure or surgery | Tirapazamine |
Primary outcome
Overall Response rate (ORR) by RECIST
Time frame: 2 years
Overall Response Rate by RECIST criteria
2 secondary outcomes
Overall Response Rate
Time frame: 2 years
Duration of Response
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 34041204Abi-Jaoudeh N, Dayyani F, Chen PJ, Fernando D, Fidelman N, Javan H, Liang PC, Hwang JI, Imagawa DK. Phase I Trial on Arterial Embolization with Hypoxia Activated Tirapazamine for Unresectable Hepatocellular Carcinoma. J Hepatocell Carcinoma. 2021 May 17;8:421-434. doi: 10.2147/JHC.S304275. eCollection 2021.
- Phase 1 dose escalation result in Hepatocellular carcinomaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ray Lee contact
Michael Soulen, MD principal investigator
Univ. of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tirapazamine and Conventional Transarterial Embolization (TAE) in people with Hepatocellular Carcinoma and Gastrointestinal Cancer Metastatic, run by Teclison Ltd. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ray Lee (info@teclison.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response rate (ORR) by RECIST (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02174549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.