REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)

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

Study Overview

• Status: Unknown
• Conditions: Hepatocellular Carcinoma

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Rheun-Chuan Lee, M.D.; Phone Number: 3069 +886-2-28712121; Email: vghtpeyttrium90@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Rheun-Chuan Lee, M.D.; Phone Number: 3069 +886-2-28712121; Email: vghtpeyttrium90@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HCC patients or colorectal cancer patients with secondary metastases in the liver.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test.	Toxicity will be accessed according to CTCAE v4.03. The incidence of adverse events will be summarized and the change in baseline liver function will be assessed by paired t-test or Wilcoxon signed rank test.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Overall survival (OS) is determined for all enrolled subjects from Day 0 to the date of death or last contact.	1 year
Overall Response Rate per RECIST 1.1 and mRECIST	Liver tumor assessments for CRC will be evaluated by RECIST v1.1; and tumor assessments for HCC will be evaluated by mRECIST. - Objective Response Rate is defined as the proportion of subjects with tumor size reduction (i.e. the combined proportion of subjects with CR and PR) from Day 0 until documented tumor progression.	1 year
Time-to-progression per RECIST 1.1 and mRECIST	The time-to-progression (TTP) is calculated by the time from Day 0 to the date of disease progression (PD).	1 year
Time-to-liver progression per RECIST 1.1 and mRECIST	The time-to-liver progression is calculated by the time from Day 0 to the date of tumor progression (PD) in intrahepatic lesions.	1 year
Progression-free survival	Progression free survival (PFS) is determined for all enrolled patients from Day 0 until tumor progression or patient death.	1 year
Liver resection rate	Patients will be assessed for suitability for liver resection every study visit during the study period.	1 year
Liver transplantation rate	Patients will be assessed for suitability for liver transplantation every study visit during the study period.	1 year

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Taiwan University Hospital; Mackay Memorial Hospital; China Medical University Hospital; Chang Gung Memorial Hospital; National Cheng-Kung University Hospital; Kaohsiung Veterans General Hospital.
• Investigators: Principal Investigator: Rheun-Chuan Lee, M.D., Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2017
• Last Update Submitted That Met QC Criteria: September 20, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; SIR Spheres; SIRT
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular
• Other Study ID Numbers: QCR14021