Clinical trial · Observational
REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
NCT03292991CI-TRIAL-00029667unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- description
- 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 outcomes (7)
- measure
- Overall survival
- timeFrame
- 1 year
- description
- Overall survival (OS) is determined for all enrolled subjects from Day 0 to the date of death or last contact.
- measure
- Overall Response Rate per RECIST 1.1 and mRECIST
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.