NCT03292991

Brief Summary

All study objectives will be assessed in HCC patients or colorectal cancer patients with secondary metastases in the liver, respectively.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 26, 2017

Status Verified

September 1, 2017

Enrollment Period

4.5 years

First QC Date

August 4, 2017

Last Update Submit

September 20, 2017

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular CarcinomaSIR SpheresSIRT

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (7)

  • Overall survival

    1 year

  • Overall Response Rate per RECIST 1.1 and mRECIST

    1 year

  • Time-to-progression per RECIST 1.1 and mRECIST

    1 year

  • Time-to-liver progression per RECIST 1.1 and mRECIST

    1 year

  • Progression-free survival

    1 year

  • +2 more secondary outcomes

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HCC patients or colorectal cancer patients with secondary metastases in the liver.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Rheun-Chuan Lee, M.D.

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rheun-Chuan Lee, M.D.

CONTACT

+886-2-28712121vghtpeyttrium90@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Dr. Rheun-Chuan Lee

Study Record Dates

First Submitted

August 4, 2017

First Posted

September 26, 2017

Study Start

June 9, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 26, 2017

Record last verified: 2017-09

Locations

TW(1)