Actively Recruiting
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Led by Teclison Ltd. · Updated on 2026-04-20
25
Participants Needed
2
Research Sites
734 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 years or older
- Well-differentiated neuroendocrine tumors with liver-dominant metastatic disease and disease progression inside the liver
- Total liver tumor volume does not exceed 50% of liver volume
- Prior FDA-approved treatments including systemic therapy, surgery, ablation, or transarterial therapies are allowed
- ECOG performance status 0 or 1
- No major cardiac, pulmonary, or renal dysfunction
- Candidates for transarterial embolization (TAE) or transarterial chemoembolization (TACE) without portal vein occlusion
- ANC (absolute neutrophil count) of at least 1000 /µL
- Hemoglobin 9 gm/dL or higher
- Platelets at least 50,000 /µL
- Creatinine no more than 2.0 mg/dL
- AST and ALT no more than 5 times the upper limit of normal
- Bilirubin no more than 2.5 mg/dL
- Prothrombin time prolongation no more than 4 seconds above the upper limit of normal
- Women of child-bearing potential must use highly effective contraception during the trial and for 6 months after last dose
- Men with partners who are women of child-bearing potential must use highly effective contraception during the trial and for 3 months after last dose
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Stanford University
Palo Alto, California, United States, 94305
Actively Recruiting
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
R
Ray Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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