Clinical trial NCT03292991: REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
Official title: REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
SIR Spheres
SIRT
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Kaohsiung Veterans General Hospital.
name: National Taiwan University Hospital
name: National Cheng-Kung University Hospital
name: China Medical University Hospital
name: Chang Gung Memorial Hospital
name: Mackay Memorial Hospital
First posted: 2017-09-26
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCC patients or colorectal cancer patients with secondary metastases in the liver.

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

Eligibility 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.

Primary outcomes:
measure: Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test.
timeFrame: 6 months
Secondary outcomes:
measure: Overall survival
timeFrame: 1 year
measure: Overall Response Rate per RECIST 1.1 and mRECIST
timeFrame: 1 year
measure: Time-to-progression per RECIST 1.1 and mRECIST
timeFrame: 1 year
measure: Time-to-liver progression per RECIST 1.1 and mRECIST
timeFrame: 1 year
measure: Progression-free survival
timeFrame: 1 year
measure: Liver resection rate
timeFrame: 1 year
measure: Liver transplantation rate
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Rheun-Chuan Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: