Combining tirapazamine with embolization for liver cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1 and 2 clinical trial aims to determine the optimal dose and tolerability of tirapazamine, a hypoxia-activating agent, when used in conjunction with embolization for patients with liver cancer. The study employs a 3+3 dose escalation design to identify the maximum tolerated dose, followed by an expansion cohort to assess preliminary efficacy in specific patient populations, including those with hepatocellular carcinoma and neuroendocrine tumors. Treatment involves intra-arterial injection of tirapazamine prior to embolization, with efficacy evaluated through MRI based on modified RECIST criteria. The trial is currently focused on patients with liver-dominant metastatic neuroendocrine tumors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. No limitation in hepatic lesion tumor size or number but the total volume of liver tumors cannot exceed 50% of the liver volume.
3. 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.
4. Age 20 or higher, ECOG functional status 0-1, and with no known major cardiac, pulmonary, or renal dysfunction.
5. Are candidates for TAE or TACE and without portal vein occlusion per treating interventional radiologists.
6. 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.
7. 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.

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Michael Soulen, MD — Univ. of Pennsylvania
• Study coordinator: Ray Lee
• Email: info@teclison.com

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.