REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)

Taipei Veterans General Hospital

Status: Unknown

Conditions: Hepatocellular Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT03292991

QCR14021

Details and patient eligibility

About

All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.

Full description

All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.

1. Primary objective:

   • To observe the safety of SIR-Spheres® microspheres therapy (SIRT)by,

     • Adverse events and serious adverse events (non-specific and radiation specific)
     • Changes in liver function parameters

   • To observe the efficacy of SIR-Spheres® microspheres therapy by, assessing the best overall response rate after SIRT

2. Secondary objectives:

   • To observe the efficacy of SIRT by,

     • Overall survival (OS)
     • Overall/objective response rate (ORR)
     • Time-to-progression
     • Time-to-liver progression
     • Progression-free survival

   • To observe the changes in clinical presentation after SIRT by,

     • ECOG score
     • Child-Pugh score
     • Percentage of subjects with down-staging or down-sizing of treated lesion to resection, transplantation, or radiofrequency ablation (RFA)

   • To observe the practice pattern of SIRT by,

     • Median dosage (GBq)
     • Number of SIRT sessions received by subjects

3. Exploratory objectives:

   • To explore prognostic factors for disease progression after SIRT by comparing the following parameters:

     • Number of tumors in subjects prior to SIRT
     • Median tumor size in subjects prior to SIRT
     • Location of tumor in subjects treated with SIRT (hepatic segment or lobe)
     • Number of prior TACE treatment in subjects
     • Antiviral therapy subjects HCC

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria, Patients who meet all inclusion criteria will be included:

• Males or non-pregnant females, at least 18 years of age (inclusive).
• Patients with clinically confirmed hepatocellular carcinoma (HCC) OR adenocarcinoma of colon/rectum with liver metastasis.
• Patients with liver dominant disease.
• Tumor burden ≤ 70% of total liver volume.
• HCC patients with child-Pugh Score class A or B.
• HCC patients with Barcelona-Clinic Liver Cancer (BCLC) stage A-C.
• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
• Patients who are unsuitable for resection or immediate liver transplantation or who cannot be optimally treated with local ablation.
• Patients who have provided written informed consent.

Exclusion Criteria, Patients who meet any exclusion criteria will be excluded:

• Patients known to be hypersensitive to any component of study product.
• Female patients who are pregnant or lactating. Women of child bearing potential who disagree to practice medically recognized birth control methods throughout the study (from Screening to approximately 6 months post SIRT). Medically recognized birth control methods include hormonal contraceptives, intrauterine device/IUD, barrier device, or abstinence. With the exception of women who had been surgically sterilized (defined as having undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy; tubal ligation alone is not considered sufficient), or one year post-menopausal.

Withdrawal criteria:

• Patients consent withdrawal.
• Lost to follow-up for 2 consecutive visits.