Hepatocellular Carcinoma study: Tirapazamine
Official title Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
ClinicalTrials.gov ID: NCT02174549
What this study is testing
What is Tirapazamine?
Tirapazamine is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hepatocellular carcinoma.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the safest and most effective dose of tirapazamine when used together with embolization and to see how well patients tolerate it.
- Who it's for
- Adults with liver cancer (hepatocellular carcinoma, metastatic gastrointestinal cancer, or neuroendocrine tumor) who are Child‑Pugh class A and have four or fewer tumors that can be treated with embolization.
- What's involved
- Participants receive an intra‑arterial injection of tirapazamine right before the embolization procedure, followed by MRI scans to assess tumor response; additional treatment is given only if the cancer progresses.
- Time commitment
- The study involves a treatment visit, MRI scans, and follow‑up visits over several months, with repeat visits only if the disease gets worse.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 99
You may be able to join if
- Patients with well-differentiated NET and liver-dominant metastatic disease with intrahepatic disease progression, regardless of primary tumor origin...
- 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...
- 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 treatment radiologists.
See the full eligibility criteria
- Patients with well-differentiated NET and liver-dominant metastatic disease with intrahepatic disease progression, regardless of primary tumor origin or tumor functional status.
- 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 treatment 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.
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Palo Alto, California, United States
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Palo Alto, California, United States; Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.