Liver NeoplasmsPhase 2NCT02969096
Clinical Study of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
A Phase 2 study testing Targeted Cryoablation Therapy in people with Liver Neoplasms, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Neoplasms
- What is being tested?
- Targeted Cryoablation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2018
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of liver cancer based on histology or the current accepted radiological measures.
- Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each tumor size≤ 3cm.
- Life expectancy: Greater than 3 months.
- Patients' liver function is Child-pugh A or B.
- Ability to understand the study protocol and a willingness to sign a written informed consent document.
- Unable to receive operative surgery.
Who cannot join
- Patients with other primary tumor except liver cancer.
- History of coagulation disorders or anemia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Safety and Efficacy of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma.
Read the detailed description
A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 10-6-10minutes.
- Conditions
- Liver Neoplasms
- Being tested
- Targeted Cryoablation Therapy
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Cryoablation TherapyProcedure or surgery
A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Cryoablation Therapy | Experimental | liver cancer patients received targeted cryoablation therapy. Receives: Procedure: Targeted Cryoablation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of complete tumor ablation
Measured: Up to 4 weeks post surgery
Secondary outcomes (1)
Adverse Events
Measured: Up to 4 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- qing wu, Bachelor, Study director, Shanghai Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969096
- Sponsor's protocol ID
- AAAA
- Status last verified
- Nov 2016
- First submitted
- 17 Nov 2016
- Last updated
- 21 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of Targeted Cryoablation Therapy in the Treatment of Hepatic Carcinoma
- ClinicalTrials.gov ID
- NCT02969096
- Acronym / sponsor ID
- AAAA
- Conditions
- Liver Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- 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.
The purpose of this study is to evaluate the safety and efficacy of targeted cryoablation therapy for hepatic carcinoma.
Detailed description
A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 10-6-10minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Targeted Cryoablation Therapy | Experimental | Procedure: Targeted Cryoablation Therapyliver cancer patients received targeted cryoablation therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of liver cancer based on histology or the current accepted radiological measures.
- Single Tumor size ≤5.0 cm in greatest diameter, or multiple tumor number≤3 and each tumor size≤ 3cm.
- Life expectancy: Greater than 3 months.
- Patients' liver function is Child-pugh A or B.
- Ability to understand the study protocol and a willingness to sign a written informed consent document.
Key exclusion criteria (2 listed)
- Patients with other primary tumor except liver cancer.
- History of coagulation disorders or anemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Cryoablation TherapyA cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively. | Procedure or surgery | Targeted Cryoablation Therapy |
Primary outcome
Rate of complete tumor ablation
Time frame: Up to 4 weeks post surgery
1 secondary outcome
Adverse Events
Time frame: Up to 4 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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.
qing wu, Bachelor study director
Shanghai Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Targeted Cryoablation Therapy in people with Liver Neoplasms, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
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 6 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 21 Nov 2016. 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 China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Rate of complete tumor ablation (time frame: Up to 4 weeks post surgery). 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 21 Nov 2016.