Nasopharyngeal CarcinomaPhase 2NCT01821495
Study of DC-CIK to Treat NPC
A Phase 2 study testing DC-CIK and Dendritic and Cytokine-induced Killer Cells in people with Nasopharyngeal Carcinoma, run by Guangxi Medical University at 1 site in China.
Trial summary
Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment failure. A series of studies reported that dendritic and cytokine-induced killer cells (DC-CIK) have a broad anti-tumor spectrum. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- DC-CIK and Dendritic and Cytokine-induced Killer Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- May 2013to May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with staging Ⅱ-Ⅲ of NPC;
- Patients who had completed concurrent of radiotherapy and chemotherapy;
- Patients who have a life expectancy of at least 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
- The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);
- The ECG results were normal, and the liver and kidney were functional.
Who cannot join
- Patients who had distant metastases by imaging studies;
- Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
- Patients who were pregnant or lactating;
- ECOG perform status ≥ 2;
- Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangxi Medical University
Nanning, Guangxi, 530000
Hanfeng Liu, Master
About this study
Official title: A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Staging Ⅱ-Ⅲ of Nasopharyngeal Carcinoma
Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment failure. A series of studies reported that dendritic and cytokine-induced killer cells (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the efficacy of DC-CIK for NPC.
Read the detailed description
About 60 patients with staging Ⅱ-Ⅲ of NPC, after accepting concurrent radiotherapy and chemotherapy, will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- DC-CIK, Dendritic and Cytokine-induced Killer Cells
- Keywords
- NPC,DC-CIK
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DC-CIKBiological
Dendritic and Cytokine-induced Killer CellsBiological
Also called DC-CIK
Concurrent of radiotherapy and chemotherapy plus 3 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment
| Study group | Role | What they receive |
|---|---|---|
| B | No intervention | After accepting concurrent radiotherapy and chemotherapy, patients will just regularly follow up. |
| A | Experimental | After accepting concurrent radiotherapy and chemotherapy, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK)treatment. Receives: Biological: DC-CIK; Biological: Dendritic and Cytokine-induced Killer Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival(PFS)
Measured: 1 month
Secondary outcomes (1)
overall survival(OS)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiliang Sun, Guangxi Medical University
- Investigators
- Hanfeng Liu, Study chair, Guangxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821495
- Sponsor's protocol ID
- NPC-01
- Status last verified
- Apr 2013
- First submitted
- 27 Mar 2013
- Last updated
- 12 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Dendritic and Cytokine-induced Killer Cells (DC-CIK) Treatment in Patients With Staging Ⅱ-Ⅲ of Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT01821495
- Acronym / sponsor ID
- NPC-01
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- NPC,DC-CIK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangxi Medical UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 1 Apr 2013 (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.
Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment failure. A series of studies reported that dendritic and cytokine-induced killer cells (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the efficacy of DC-CIK for NPC.
Detailed description
About 60 patients with staging Ⅱ-Ⅲ of NPC, after accepting concurrent radiotherapy and chemotherapy, will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | No intervention | –After accepting concurrent radiotherapy and chemotherapy, patients will just regularly follow up. |
| A | Experimental | Biological: DC-CIK, Biological: Dendritic and Cytokine-induced Killer CellsAfter accepting concurrent radiotherapy and chemotherapy, patients will receive 3 cycles of Dendritic and Cytokine-induced Killer Cells (DC-CIK)treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with staging Ⅱ-Ⅲ of NPC;
- Patients who had completed concurrent of radiotherapy and chemotherapy;
- Patients who have a life expectancy of at least 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
- The bone marrow functioned normally (WBC > 4.0×109/L, Hb > 120 g/L, PLT > 100×109/L);
Key exclusion criteria (5 listed)
- Patients who had distant metastases by imaging studies;
- Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
- Patients who were pregnant or lactating;
- ECOG perform status ≥ 2;
- Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
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 |
|---|---|---|
| DC-CIK | Biological | A |
| Dendritic and Cytokine-induced Killer CellsAlso: DC-CIKConcurrent of radiotherapy and chemotherapy plus 3 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment | Biological | A |
Primary outcome
progression-free survival(PFS)
Time frame: 1 month
1 secondary outcome
overall survival(OS)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2013.
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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.
Hanfeng Liu study chair
Guangxi Medical University
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 DC-CIK and Dendritic and Cytokine-induced Killer Cells in people with Nasopharyngeal Carcinoma, run by Guangxi Medical University 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 5 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 12 Apr 2013. 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?
Contact Weiliang Sun, M.D. (86-771-3277289, swl20012002@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival(PFS) (time frame: 1 month). 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 12 Apr 2013.