Hepatocellular CarcinomaNCT03292991
REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
An observational study of Hepatocellular Carcinoma, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Jun 2015to Dec 2019
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HCC patients or colorectal cancer patients with secondary metastases in the liver.
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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Rheun-Chuan Lee, M.D., +886-2-28712121 ext. 3069, vghtpeyttrium90@gmail.com
About this study
All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.
Read the detailed description
All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.
- 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
- 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
- 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
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, SIR Spheres, SIRT
- Medical subject headings
- Carcinoma, Hepatocellular
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test.
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.
Measured: 6 months
Secondary outcomes (7)
Overall survival
Overall survival (OS) is determined for all enrolled subjects from Day 0 to the date of death or last contact.
Measured: 1 year
Overall Response Rate per RECIST 1.1 and mRECIST
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.
Measured: 1 year
Time-to-progression per RECIST 1.1 and mRECIST
The time-to-progression (TTP) is calculated by the time from Day 0 to the date of disease progression (PD).
Measured: 1 year
Time-to-liver progression per RECIST 1.1 and mRECIST
The time-to-liver progression is calculated by the time from Day 0 to the date of tumor progression (PD) in intrahepatic lesions.
Measured: 1 year
Progression-free survival
Progression free survival (PFS) is determined for all enrolled patients from Day 0 until tumor progression or patient death.
Measured: 1 year
Liver resection rate
Patients will be assessed for suitability for liver resection every study visit during the study period.
Measured: 1 year
Liver transplantation rate
Patients will be assessed for suitability for liver transplantation every study visit during the study period.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start9 Jun 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Kaohsiung Veterans General Hospital., National Taiwan University Hospital, National Cheng-Kung University Hospital, China Medical University Hospital, Chang Gung Memorial Hospital, Mackay Memorial Hospital
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Rheun-Chuan Lee, M.D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292991
- Sponsor's protocol ID
- QCR14021
- Status last verified
- Sep 2017
- First submitted
- 4 Aug 2017
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REgistry of Selective Internal Radiation Therapy in TaiwaN (RESIN)
- ClinicalTrials.gov ID
- NCT03292991
- Acronym / sponsor ID
- QCR14021
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma, SIR Spheres, SIRT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Kaohsiung Veterans General Hospital., National Taiwan University Hospital, National Cheng-Kung University Hospital, China Medical University Hospital, Chang Gung Memorial Hospital, Mackay Memorial Hospital
- Study start
- 9 Jun 2015 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- 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
- 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCC patients or colorectal cancer patients with secondary metastases in the liver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test.
Time frame: 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.
7 secondary outcomes
Overall survival
Time frame: 1 year
Overall Response Rate per RECIST 1.1 and mRECIST
Time frame: 1 year
Time-to-progression per RECIST 1.1 and mRECIST
Time frame: 1 year
Time-to-liver progression per RECIST 1.1 and mRECIST
Time frame: 1 year
Progression-free survival
Time frame: 1 year
Liver resection rate
Time frame: 1 year
Liver transplantation rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rheun-Chuan Lee, M.D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rheun-Chuan Lee, M.D. (+886-2-28712121 ext. 3069, vghtpeyttrium90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as per CTCAE 4.03, incidence of AEs and baseline change in liver function paired t-test or Wilcoxon signed rank test. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2017.