Liver CancerNCT03317483
DEB-TACE Treatment in 367 Liver Cancer Patients
An observational study of Liver Cancer, run by Zhejiang Cancer Hospital.
Trial summary
Introduction:The drug-eluting beads transarterial chemoembolization (DEB-TACE) is introduced to better improve efficacy and reduce the systemic toxicity in liver cancer patients on account of its higher intratumoral chemotherapeutic drug concentration and reduced drug infiltration into systemic circulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- How many people
- 367 participants
- Where
- No sites listed yet
- Study dates
- 12 Nov 2015to 28 Dec 2016
- How long will I take part?
- 404 Days
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: 367 liver cancer patients about to receive DEB-TACE treatment from 2015/11/12 to 2016/11/04 were prospectively included in CTILC study.
Who may be able to join
- Diagnosed as primary HCC, primary ICC or secondary liver cancer confirmed by pathological findings, clinical features or radiographic examinations according to American Association for the Study of the Liver Diseases (AASLD) guidelines;
- Age above 18 years;
- About to receive DEB-TACE treatment with CalliSpheres® according to clinical needs and patients' willing.
- Able to be followed up regularly;
- Life expectancy above 12 months.
Who cannot join
- History of liver transplantation;
- History of hematological malignances;
- Severe hepatic failure or renal failure;
- Contraindication for angiography, embolization procedure or artery puncture;
- Patients with cognitive impairment, or unable to understand the study consents.
- Women in gestation or lactation period.
About this study
Official title: The Comprehensive Analysis of Efficacy and Safety of CalliSpheres® Drug-eluting Beads Transarterial Chemoembolization in 367 Patients With Liver Cancer: a Multiple-center Cohort Study (CTILC Study)
Introduction:The drug-eluting beads transarterial chemoembolization (DEB-TACE) is introduced to better improve efficacy and reduce the systemic toxicity in liver cancer patients on account of its higher intratumoral chemotherapeutic drug concentration and reduced drug infiltration into systemic circulation. This study aimed to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.
Hypothesis:DEB-TACE illustrates a better treatment response, progression free survival (PFS), overall survival (OS) and less common adverse events (AEs) in liver cancer patients.
Objective: to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.
- Conditions
- Liver Cancer
- Medical subject headings
- Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment response
Treatment response was assessed at 1-3 months after DEB-TACE treatment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) by enhanced computerized tomography (CT) or magnetic resonance imaging (MRI) examination.
Measured: One-three months after DEB-TACE treatment
Secondary outcomes (3)
overall survival
OS was calculated from the time of DEB-TACE operation to the time of patient's death from any causes.
Measured: The median follow-up duration was 171 (range from 38 to 404) days.
Liver function evaluation
Liver function indexes including ALB, TP, TBIL, TBA, ALT, AST and ALP were recorded before, 1 week post and 1-3 months post DEB-TACE treatment to evaluate the influence of DEB-TACE on liver function. The analysis of liver function evaluation was based on the treatment records of DEB-TACE .
Measured: One week post and 1-3 months post DEB-TACE treatment.
Adverse events (AEs)
AEs were recorded during DEB-TACE operation and 1 month after DEB-TACE operation, and the analysis of AEs was based on the treatment records of DEB-TACE.
Measured: During DEB-TACE operation and 1 month after DEB-TACE operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start12 Nov 2015
- Primary completion4 Nov 2016
- Study completion28 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 367 participants (actual)
- Target duration
- 404 Days
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, guoliang shao, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317483
- Sponsor's protocol ID
- CTILC
- Status last verified
- Oct 2017
- First submitted
- 13 Oct 2017
- Last updated
- 23 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo J, Zheng J, Shi C, Fang J, Peng Z, Huang J, Sun J, Zhou G, Li T, Zhu D, Xu H, Hou Q, Ying S, Sun Z, Du H, Xie X, Cao G, Ji W, Han J, Gu W, Guo X, Shao G, Yu Z, Zhou J, Yu W, Zhang X, Li L, Hu H, Hu T, Wu X, Chen Y, Ji J, Hu W. Drug-eluting beads transarterial chemoembolization by CalliSpheres is effective and well tolerated in treating intrahepatic cholangiocarcinoma patients: A preliminary result from CTILC study. Medicine (Baltimore). 2020 Mar;99(12):e19276. doi: 10.1097/MD.0000000000019276.
PubMed 32195932
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comprehensive Analysis of Efficacy and Safety of CalliSpheres® Drug-eluting Beads Transarterial Chemoembolization in 367 Patients With Liver Cancer: a Multiple-center Cohort Study (CTILC Study)
- ClinicalTrials.gov ID
- NCT03317483
- Acronym / sponsor ID
- CTILC
- Conditions
- Liver Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 12 Nov 2015 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 28 Dec 2016 (actual)
- First posted
- 23 Oct 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.
Introduction:The drug-eluting beads transarterial chemoembolization (DEB-TACE) is introduced to better improve efficacy and reduce the systemic toxicity in liver cancer patients on account of its higher intratumoral chemotherapeutic drug concentration and reduced drug infiltration into systemic circulation. This study aimed to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.
Hypothesis:DEB-TACE illustrates a better treatment response, progression free survival (PFS), overall survival (OS) and less common adverse events (AEs) in liver cancer patients.
Objective: to investigate the efficacy, safety and prognostic factors of DEB-TACE treatment in Chinese patients with liver cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 404 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 367 liver cancer patients about to receive DEB-TACE treatment from 2015/11/12 to 2016/11/04 were prospectively included in CTILC study.
Key inclusion criteria (5 listed)
- Diagnosed as primary HCC, primary ICC or secondary liver cancer confirmed by pathological findings, clinical features or radiographic examinations according to American Association for the Study of the Liver Diseases (AASLD) guidelines;
- Age above 18 years;
- About to receive DEB-TACE treatment with CalliSpheres® according to clinical needs and patients' willing.
- Able to be followed up regularly;
- Life expectancy above 12 months.
Key exclusion criteria (6 listed)
- History of liver transplantation;
- History of hematological malignances;
- Severe hepatic failure or renal failure;
- Contraindication for angiography, embolization procedure or artery puncture;
- Patients with cognitive impairment, or unable to understand the study consents.
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
Treatment response
Time frame: One-three months after DEB-TACE treatment
Treatment response was assessed at 1-3 months after DEB-TACE treatment according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) by enhanced computerized tomography (CT) or magnetic resonance imaging (MRI) examination.
3 secondary outcomes
overall survival
Time frame: The median follow-up duration was 171 (range from 38 to 404) days.
Liver function evaluation
Time frame: One week post and 1-3 months post DEB-TACE treatment.
Adverse events (AEs)
Time frame: During DEB-TACE operation and 1 month after DEB-TACE operation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
- Derived from this study: PubMed 32195932Luo J, Zheng J, Shi C, Fang J, Peng Z, Huang J, Sun J, Zhou G, Li T, Zhu D, Xu H, Hou Q, Ying S, Sun Z, Du H, Xie X, Cao G, Ji W, Han J, Gu W, Guo X, Shao G, Yu Z, Zhou J, Yu W, Zhang X, Li L, Hu H, Hu T, Wu X, Chen Y, Ji J, Hu W. Drug-eluting beads transarterial chemoembolization by CalliSpheres is effective and well tolerated in treating intrahepatic cholangiocarcinoma patients: A preliminary result from CTILC study. Medicine (Baltimore). 2020 Mar;99(12):e19276. doi: 10.1097/MD.0000000000019276.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Zhejiang Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (time frame: One-three months after DEB-TACE treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317483, which also lists 1 linked publication.
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 23 Oct 2017.