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New treatment option for Hepatocellular Carcinoma
Official title Combination of TATE and PD-1 Inhibitor in Liver Cancer
ClinicalTrials.gov ID: NCT03259867
What this study is testing
What is Nivolumab Injectable Product?
Nivolumab Injectable Product is an investigational medicine, being studied as a potential treatment for hepatocellular carcinoma.
Also referred to as OPDIVO.
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
- This is a multi-center, open-label phase IIA study that investigates the preliminary efficacy of Trans-arterial Tirapazamine Embolization (TATE) treatment of liver cancer followed by a PD-1 checkpoint inhibitor (nivolumab). Patients with two types of cancers will be enrolled, advanced hepatocellular carcinoma (HCC),and metastatic gastric cancer.
- 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 18 to 80
You may be able to join if
- Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric cancer.
- Patients between ages 18 and 80
- If HCC patients, they should have progressive disease (PD) on an immune therapy for advanced HCC. For patients with metastatic gastric cancer, they...
- Patients with liver tumor lesions with at least one with a diameter of 2 cm or bigger, which is amendable for (super-)selective TATE as the target...
- ECOG score 2 or less
See the full eligibility criteria
- Patients with a confirmed diagnosis of (1) advanced HCC or (2) metastatic gastric cancer.
- Patients between ages 18 and 80
- If HCC patients, they should have progressive disease (PD) on an immune therapy for advanced HCC. For patients with metastatic gastric cancer, they should have failed at least one line of systemic chemotherapy and an...
- Patients with liver tumor lesions with at least one with a diameter of 2 cm or bigger, which is amendable for (super-)selective TATE as the target lesion.
- ECOG score 2 or less
- Child-Pugh scores 5-7 for HCC patients
- All prior chemotherapy at least 4 weeks prior to study treatment. Immunotherapy not subject to this limitation.
- No major GI bleeding in the prior 2 months. 8\. Hgb\>=8, platelet \>= 50,000, Cr =\< 2, AST and ALT \< 10 X ULN, t-Bilirubin \< 3, 9. Patients with a history of major autoimmune disorders excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Orange, California, United States
- Oklahoma City, Oklahoma, United States
- Milwaukee, Wisconsin, 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 - 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, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Orange, California, United States; Oklahoma City, Oklahoma, United States; Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.