Status:
UNKNOWN
REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
Lead Sponsor:
Taipei Veterans General Hospital, Taiwan
Collaborating Sponsors:
Kaohsiung Veterans General Hospital.
National Taiwan University Hospital
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20+ years
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-Sphe...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 9 2015
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03292991
Start Date
June 9 2015
End Date
December 1 2019
Last Update
September 26 2017
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan, 11217