| NCT ID | NCT05994859 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Hepatocellular Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2023-08-10 |
| Primary Completion | 2026-08-09 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 35 participants in total. It began in 2023-08-10 with a primary completion date of 2026-08-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05994859 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Hepatocellular Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05994859 currently recruiting?
Yes, NCT05994859 is actively recruiting participants. Contact the research team at cai020@yeah.net for enrollment information.
Where is the NCT05994859 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05994859 clinical trial?
NCT05994859 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 35 participants.
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