Hepatocellular Carcinoma
Conditions
Keywords
Hepatocellular Carcinoma, SIR Spheres, SIRT
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
Interventions
None listed
Sponsors
Kaohsiung Veterans General Hospital.
National Taiwan University Hospital
National Cheng-Kung University Hospital
China Medical University Hospital
Chang Gung Memorial Hospital
Mackay Memorial Hospital
Taipei Veterans General Hospital, Taiwan
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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. |
| Overall survival | 1 year | Overall survival (OS) is determined for all enrolled subjects from Day 0 to the date of death or last contact. |
| Liver resection rate | 1 year | Patients will be assessed for suitability for liver resection every study visit during the study period. |
| Liver transplantation rate | 1 year | Patients will be assessed for suitability for liver transplantation every study visit during the study period. |
| Progression-free survival | 1 year | Progression free survival (PFS) is determined for all enrolled patients from Day 0 until tumor progression or patient death. |
Countries
Taiwan
Contacts
Primary ContactRheun-Chuan Lee, M.D.
Outcome results
None listed