Selective internal radiation therapy for liver cancer

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 study evaluates the efficacy and safety of Y-90 selective internal radiation therapy (SIRT) in patients with potentially resectable hepatocellular carcinoma (HCC). It is a bi-center, prospective study enrolling 35 patients who will receive 1-2 sessions of SIRT. If patients are deemed resectable during follow-up, liver resection will be recommended. The study aims to assess the success rate of conversion to resection and other secondary endpoints related to disease response and survival.

Why it matters

Who can join: the full rules

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

Where it's running

• The Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Mingyue Cai, Dr.
• Email: cai020@yeah.net
• Phone: +86-20-34156205

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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.