Lung CancerCIKNCT01498055
Autologous CIK Cells Infusion for the Treatment of Lung Cancer: a Randomized Controlled Study
An observational study of Lung Cancer, run by Third Military Medical University at 1 site in China.
Trial summary
To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Cancer
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2013
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary lung cancer diagnosis (including small cell lung cancer, lung adenocarcinoma, lung squamous cell carcinoma and large cell carcinoma) patients
Who may be able to join
- 18~70 year old, KPS score >50 points, estimate survival > 3 months;
- Primary lung cancer patients after chemotherapy or radiation therapy;
- Primary lung cancer patients after targeted therapy;
- Primary lung cancer patients with lung function can not accept operation or unwilling to operation;
- Primary lung cancer recurrence or surgery can't complete resection;
- Primary lung cancer patients after intervention therapy(I125 implanted, freezing, rf, etc.);
- No serious mental illness and no serious heart, liver, kidney diseases, unincorporated other potentially lethal diseases;
- Patients Voluntary attempt, and informed consent.
Who cannot join
- History of cardiovascular disease: congestive heart failure > New York heart association (NYHA) level II, unstable angina patients (resting when the angina symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of myocardial infarction;
- Cachexia; or other deadly diseases;
- Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit;
- Active infection;
- Pregnant or lactating women
- At present Is receiving other cancer treatment (such as chemotherapy, radiation therapy, chemotherapy, immunosuppressants and thrombosis, targeted agents);
- Now or recently will join another experimental clinical study ;
- Other situations that the researchers considered unsuitable for this study (such as mental illness, drug abuse, HIV infections, etc.), or influence on the results of clinical trials for analysis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Liang Gong
Chongqing, Chong Qing, 400038
Liang Gong, 13983965893, gonglw1@gmail.com
Liang Gong
About this study
Official title: A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer
To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.
Read the detailed description
A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer
- Conditions
- Lung Cancer
- Keywords
- lung cancer, CIK cells, therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CIK therapy group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rates (DCR)
Lung lesions of disease control rates DCR (CR + PR + SD), according to solid tumor response evaluation standard (response evaluation criteria in solid tumors, RECIST) standard
Measured: From 12-2011 to 12-2013
Secondary outcomes (1)
Overall Survival(OS)
Disease progression-free surial (Progression-Free Srvival, PFS) with observations
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gong Liang, Third Military Medical University
- Investigators
- Xiangdong Zhou, Study chair, Southwest Hospital Third Military University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498055
- Sponsor's protocol ID
- GLiang
- Acronym
- CIK
- Status last verified
- Dec 2011
- First submitted
- 24 Nov 2011
- Last updated
- 22 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trail on the Efficacy and Safety of Autologous Cytokine-induced Killer (CIK) Cells Infusion Treatment in Advanced Primary Lung Cancer
- ClinicalTrials.gov ID
- NCT01498055
- Acronym / sponsor ID
- CIK / GLiang
- Conditions
- Lung Cancer
- Keywords
- lung cancer, CIK cells, therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Dec 2011 (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.
To study the efficacy and safety of autologous CIK cells infusion for the treatment of lung cancer.
Detailed description
A randomized controlled trail on the efficacy and safety of autologous cytokine-induced killer (CIK) cells infusion treatment in advanced primary lung cancer
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIK therapy group | – | – |
| control group | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary lung cancer diagnosis (including small cell lung cancer, lung adenocarcinoma, lung squamous cell carcinoma and large cell carcinoma) patients
Key inclusion criteria (8 listed)
- 18~70 year old, KPS score >50 points, estimate survival > 3 months;
- Primary lung cancer patients after chemotherapy or radiation therapy;
- Primary lung cancer patients after targeted therapy;
- Primary lung cancer patients with lung function can not accept operation or unwilling to operation;
- Primary lung cancer recurrence or surgery can't complete resection;
Key exclusion criteria (8 listed)
- History of cardiovascular disease: congestive heart failure > New York heart association (NYHA) level II, unstable angina patients (resting when the angina symptoms) or new happen angina pectoris (recent 3 months) or recent 6 months of myocardial infarction;
- Cachexia; or other deadly diseases;
- Liver function laboratory ALT, AST more than normal limits on 2.0 times ; Or kidney TBIL, BUN more than normal limits on 1.0 times , or Cr more than normal upper limit;
- Active infection;
- Pregnant or lactating women
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
Disease Control Rates (DCR)
Time frame: From 12-2011 to 12-2013
Lung lesions of disease control rates DCR (CR + PR + SD), according to solid tumor response evaluation standard (response evaluation criteria in solid tumors, RECIST) standard
1 secondary outcome
Overall Survival(OS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
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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.
Xiangdong Zhou study chair
Southwest Hospital Third Military University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Third Military 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 8 inclusion and 8 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 22 Mar 2012. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rates (DCR) (time frame: From 12-2011 to 12-2013). 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 22 Mar 2012.