Selective internal radiation therapy for liver cancer

Y-90 Selective Internal Radiation Therapy for Potentially Resectable Hepatocellular Carcinoma: a Prospective, Single Arm Trial

This study is testing if a special type of radiation therapy can help patients with liver cancer become healthy enough for surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05994859 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with potentially resectable hepatocellular carcinoma who have not received prior treatment.

Not a fit: Patients with advanced liver disease or those with extensive vascular invasion may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the chances of surgical resection for patients with liver cancer.

How similar studies have performed: Other studies have shown promising results with selective internal radiation therapy in similar patient populations.

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

Where this trial is running

Guangzhou, Guangdong

• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Mingyue Cai, Dr.

Conditions: Hepatocellular Carcinoma, unresectable, selective internal radiation therapy