CompletedNCT02545556Updated Aug 29, 2016

Liver Cancer HepaSphere Combined With Cryosurgery

A Phase 1/2 interventional study of HepaSphere combined with cryosurgery in Liver Cancer, sponsored by Fuda Cancer Hospital, Guangzhou. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-29.

Sponsored by Fuda Cancer Hospital, Guangzhou · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 60
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

The purpose of this study is to evaluate the safety and efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA）combined with cryosurgery for liver cancer.

Read the detailed description

By enrolling patients with liver cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of HepaSphere interventional therapy using digital subtraction angiography（DSA） combined with cryosurgery for liver cancer.

Conditions studied

Liver Cancer

Browse trials for

Liver Neoplasms 1,406

Keywords

Liver Cancer
HepaSphere
cryosurgery

In context

Liver Neoplasms

1,406 studies on the registry are indexed under Liver Neoplasms; 347 are open to participants now.

This study's enrollment of 60 is above the median of 47 across 975 interventional studies indexed under Liver Neoplasms.

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Lead sponsor

Fuda Cancer Hospital, Guangzhou is the lead sponsor of 116 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age:18-80
Karnofsky performance status >60
Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
Will receive interventional therapy
Life expectancy: Greater than 3 months
Patients' routine blood test, liver function and kidney function have no obvious abnormalities
Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion criteria

Exclusion Criteria:

Patients with other primary tumor except liver cancer
History of coagulation disorders or anemia

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 60 participants (actual)

Study arms

Experimental
HepaSphere combined with cryosurgery
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
Procedure: HepaSphere combined with cryosurgery
Placebo comparator
control
liver cancer patients received traditional therapy
Procedure: HepaSphere combined with cryosurgery

Interventions

ProcedureHepaSphere combined with cryosurgery
liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery

What researchers measure

Primary outcomes

Number of participants with Adverse events
Time frame: 1 year

Secondary outcomes

Percentage of lesions interventional therapy that show no sign of recurrence 12 months after
Time frame: 1 year
Progress free disease (PFS)
Time frame: 1 year
Overall survival (OS)
Time frame: 3 year

Study locations

1 site

Central laboratory in Fuda cancer hospital
Guangzhou, Guangdong 510000, China

References and documents

Publications

Niu L, Chen J, Yao F, Zhou L, Zhang C, Wen W, Bi X, Hu Y, Piao X, Jiang F, Zeng J, Liu W, Li J, He L, Mu F, Zuo J, Xu K. Percutaneous cryoablation for stage IV lung cancer: a retrospective analysis. Cryobiology. 2013 Oct;67(2):151-5. doi: 10.1016/j.cryobiol.2013.06.005. Epub 2013 Jun 24. PubMed 23806858 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2015, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 8, 2015
First posted: Sep 10, 2015
Start: Aug 2015
Primary completionActual: Aug 2016
CompletionActual: Aug 2016
Last update: Aug 29, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02545556
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Responsible party: Sponsor
First posted: Sep 10, 2015
Start date: Aug 2015
Primary completion: Aug 2016
Completion: Aug 2016
Last update: Aug 29, 2016

Study contacts

Lizhi Niu, PhD

study chair · Fuda Cancer Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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