NCT05994859Recruiting
SIRT for Potentially Resectable HCC
Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial
Source: ClinicalTrials.gov · Last updated 14 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study is conducted to evaluate the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 35 (estimated)
- First submitted
- 9 Aug 2023
- Start date
- 10 Aug 2023
- Primary completion date
- 9 Aug 2026
- Lead sponsor
- Second Affiliated Hospital of Guangzhou Medical University
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT05994859
What you commit to
- Study type: Interventional
- Planned participants: 35
- From 10 Aug 2023 to the primary completion date, 9 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Decompensated liver function, including ascites, bleeding from esophageal and gastric varices, and/or hepatic encephalopathy
- Organ (heart, kidney) dysfunction
- HBsAg and anti-HCV antibody positive concurrently
- History of malignancy other than HCC
- Uncontrolled infection
- History of HIV
- History of organ and cell transplantation
- Patients with bleeding tendency
Other
- Tumor involving main portal vein, bilateral branches of portal vein, or vena cava
- tumor extention beyond one lobe of the liver
- Bilobar tumor distribution
- Extrahepatic metastasis
Who the study is looking for
- HCC with diagnosis confirmed pathologically or clinically
- No pervious treatment for HCC
- At least one measurable intrahepatic target lesion
- Potentially resectable HCC: tumor(s) confined to the left/right hemiliver, with/without invasion to the unilateral branch of the portal vein and/or hepatic vein
- Disease amenable to SIRT (after evaluation)
- Child-Pugh Class A or without cirrhosis
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
- Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^3 IU/mL
- Patients with hepatitis C need to finish the anti-HCV treatment
- Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/L, white blood cell count \>3.0×10\^9/L, absolute value of neutrophils \>1.5×10\^9/L, hemoglobin ≥85 g/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range
- Life expectancy of at least 6 months
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.