CholangiocarcinomaPhase 2/3NCT02482454
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
A Phase 2/3 study testing Radiofrequency ablation and Cytokine-induced killer cells in people with Cholangiocarcinoma, run by The First People's Hospital of Changzhou at 1 site in China.
Trial summary
The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cholangiocarcinoma. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Cholangiocarcinoma
- What is being tested?
- Radiofrequency ablation and Cytokine-induced killer cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Jul 2033
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically confirmed cholangiocarcinoma
- Primary lesions (cholangiocarcinoma) are not resected
- Serum bilirubin level of 2.0 mg/dl or less.
- Performance status of 0 or 1.
- Expected survival of 1 year or more.
- Informed consent from the patient.
Who cannot join
- With extrahepatic metastases
- With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cholangiocarcinoma.
Read the detailed description
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.
- Conditions
- Cholangiocarcinoma
- Being tested
- Radiofrequency ablation, Cytokine-induced killer cells
- Keywords
- radiofrequency ablation, cytokine-induced killer cells, cholangiocarcinoma
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
Also called RFA
Radiofrequency ablation is performed percutaneously under CT/US guidance
Cytokine-induced killer cellsBiological
Also called CIK
The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.
| Study group | Role | What they receive |
|---|---|---|
| RFA alone | Other | Patients undergo radiofrequency ablation alone. Receives: Procedure: Radiofrequency ablation |
| RFA+CIK | Experimental | Autologous cytokine-induced killer cells were transfer via venous one week after RFA Receives: Procedure: Radiofrequency ablation; Biological: Cytokine-induced killer cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence-free survival
Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.
Measured: 1 year
Secondary outcomes (1)
Adverse events
Adverse events related to RFA and CIK treatments.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startJul 2012
- Primary completionJul 2030 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Changzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, peng du, The First People's Hospital of Changzhou
- Investigators
- Changping Wu, M.D., Study director, The First People's Hospital of Changzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482454
- Sponsor's protocol ID
- chol001
- Status last verified
- Feb 2017
- First submitted
- 24 Jun 2015
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT02482454
- Acronym / sponsor ID
- chol001
- Conditions
- Cholangiocarcinoma
- Keywords
- radiofrequency ablation, cytokine-induced killer cells, cholangiocarcinoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- The First People's Hospital of ChangzhouUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 26 Jun 2015 (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 determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with cholangiocarcinoma.
Detailed description
The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with cholangiocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RFA alone | Other | Procedure: Radiofrequency ablationPatients undergo radiofrequency ablation alone. |
| RFA+CIK | Experimental | Procedure: Radiofrequency ablation, Biological: Cytokine-induced killer cellsAutologous cytokine-induced killer cells were transfer via venous one week after RFA |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically confirmed cholangiocarcinoma
- Primary lesions (cholangiocarcinoma) are not resected
- Serum bilirubin level of 2.0 mg/dl or less.
- Performance status of 0 or 1.
- Expected survival of 1 year or more.
Key exclusion criteria (2 listed)
- With extrahepatic metastases
- With other neoplastic disease that is measurable or being treated other than cholangiocarcinoma.
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 |
|---|---|---|
| Radiofrequency ablationAlso: RFARadiofrequency ablation is performed percutaneously under CT/US guidance | Procedure or surgery | RFA alone, RFA+CIK |
| Cytokine-induced killer cellsAlso: CIKThe patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment. | Biological | RFA+CIK |
Primary outcome
Recurrence-free survival
Time frame: 1 year
Recurrence-free survival (RFS) was defined as the time from the date of RFA to the date of recurrence or the date of the last follow-up.
1 secondary outcome
Adverse events
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- Individual participant dataSharing planned: No
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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.
Changping Wu, M.D. study director
The First People's Hospital of Changzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Radiofrequency ablation and Cytokine-induced killer cells in people with Cholangiocarcinoma, run by The First People's Hospital of Changzhou 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: under way, not looking for participants, as of the sponsor's last update on 1 Aug 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 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Recurrence-free survival (time frame: 1 year). 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 1 Aug 2017.