REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
- Conditions
- Hepatocellular Carcinoma
- Registration Number
- NCT03292991
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- Brief Summary
All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test. 6 months 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.
- Secondary Outcome Measures
Name Time Method Overall survival 1 year Overall survival (OS) is determined for all enrolled subjects from Day 0 to the date of death or last contact.
Time-to-progression per RECIST 1.1 and mRECIST 1 year The time-to-progression (TTP) is calculated by the time from Day 0 to the date of disease progression (PD).
Progression-free survival 1 year Progression free survival (PFS) is determined for all enrolled patients from Day 0 until tumor progression or patient death.
Liver transplantation rate 1 year Patients will be assessed for suitability for liver transplantation every study visit during the study period.
Overall Response Rate per RECIST 1.1 and mRECIST 1 year 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.Liver resection rate 1 year Patients will be assessed for suitability for liver resection every study visit during the study period.
Time-to-liver progression per RECIST 1.1 and mRECIST 1 year The time-to-liver progression is calculated by the time from Day 0 to the date of tumor progression (PD) in intrahepatic lesions.
Trial Locations
- Locations (1)
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan