NSCLCPhase 2NCT02766348
Clinical Efficacy and Safety of Dendritic Cytotoxic Lymphocyte(DC-CTL) Cell Infusion in NSCLC Patients
A Phase 2 study testing gemcitabine, DC-CTL and cisplatinum in people with NSCLC, run by Shenzhen Hornetcorn Bio-technology Company, LTD at 1 site in China.
Trial summary
Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will receive only chemotherapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NSCLC
- What is being tested?
- gemcitabine, DC-CTL and cisplatinum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient who have signed the informed consent;
- Histologically confirmed with NSCLC at stage III-IV
- Expected survival time is more than 2 month;
- Eastern Cooperative Oncology Group(ECOG) performance status was 0-2
Who cannot join
- Hemoglobin <8.0 g/dL, White blood cell <3 x 10^9/L; Platelet count <75 x 10^9/L; alanine aminotransferase(ALT), aspartate aminotransferase(AST), blood urea nitrogen(BUN) and Creatinine(CR) more than normal limits on 3.0 times;
- Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- Pregnant or lactating patients;
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
- Patients who are suffering from serious autoimmune disease;
- Patients who had used long time or are using immunosuppressant;
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- Patients who had active infection;
- Patients who are suffering from serious organ dysfunction;
- Patients who are suffering from other cancer;
- Other situations that the researchers considered unsuitable for this study.
Trial locations and contacts
1 site in 1 country.
Zi L Zhang, researcher contact
China1 site
Jingzhou Central hospital Immunotherapy center
Jingzhou, Hubei, 434020
Fan Fu, Researcher, +86 15027082046, Fufan@hornetcorn.com
Fan Fu
About this study
Official title: Randomized, Controlled Study of the Safety and Efficacy of DC-CTL Immune Cell for Non-Small Cell Lung Cancer
Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will receive only chemotherapy.
Read the detailed description
60 patients with stage III-IV NSCLC will be randomly divided into group A (receive DC-CTL treatment with chemotherapy) or group B (Just receive chemotherapy), and the randomize ratio will be 1:1, patients in group A will receive 3 cycles of DC-CTL treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks). Patients in group B will receive only 4 cycles chemotherapy(every 2 weeks).
- Conditions
- NSCLC
- Being tested
- gemcitabine, DC-CTL, cisplatinum
- Keywords
- DC-CTL, NSCLC
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
Also called Gemzar
gemcitabine 1000mg/m2 IV on day 1 an day 8, repeat every 3 weeks
DC-CTLBiological
8×10^9 DC-CTL cells for each infusion, IV(In the vein) for 3 cycles, each cycle received four infusions on day 14,16,30 and 32
cisplatinumDrug
cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DC-CTL | Experimental | After accepting chemotherapy of gGemcitabine and Cisplatin according to National comprehensive Cancer Network(NCCN) guidelines, patients will receive 3 cycles of DC-CTL treatment Receives: Drug: gemcitabine; Biological: DC-CTL; Drug: cisplatinum |
| Chemotherapy | Active comparator | After accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up. Receives: Drug: gemcitabine; Drug: cisplatinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free survival
Measured: 3 years
Secondary outcomes (1)
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2017 (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 NSCLCStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zi L Zhang, researcher, Study director, Jingzhou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02766348
- Sponsor's protocol ID
- HYK-DC-CTL-NSCLC
- Status last verified
- May 2016
- First submitted
- 5 May 2016
- Last updated
- 9 May 2016
- 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 9 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Study of the Safety and Efficacy of DC-CTL Immune Cell for Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT02766348
- Acronym / sponsor ID
- HYK-DC-CTL-NSCLC
- Conditions
- NSCLC
- Keywords
- DC-CTL, NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTDIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 9 May 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.
Patients in group A will receive DC-CTL treatment and chemotherapy. Patients in group B will receive only chemotherapy.
Detailed description
60 patients with stage III-IV NSCLC will be randomly divided into group A (receive DC-CTL treatment with chemotherapy) or group B (Just receive chemotherapy), and the randomize ratio will be 1:1, patients in group A will receive 3 cycles of DC-CTL treatment (every 1 months) and 4 cycles of chemotherapy (every 2 weeks). Patients in group B will receive only 4 cycles chemotherapy(every 2 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DC-CTL | Experimental | Drug: gemcitabine, Biological: DC-CTL, Drug: cisplatinumAfter accepting chemotherapy of gGemcitabine and Cisplatin according to National comprehensive Cancer Network(NCCN) guidelines, patients will receive 3 cycles of DC-CTL treatment |
| Chemotherapy | Active comparator | Drug: gemcitabine, Drug: cisplatinumAfter accepting chemotherapy of Gemcitabine and Cisplatin according to NCCN guidelines, patients will just regularly follow up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patient who have signed the informed consent;
- Histologically confirmed with NSCLC at stage III-IV
- Expected survival time is more than 2 month;
- Eastern Cooperative Oncology Group(ECOG) performance status was 0-2
Key exclusion criteria (10 listed)
- Hemoglobin <8.0 g/dL, White blood cell <3 x 10^9/L; Platelet count <75 x 10^9/L; alanine aminotransferase(ALT), aspartate aminotransferase(AST), blood urea nitrogen(BUN) and Creatinine(CR) more than normal limits on 3.0 times;
- Known or suspected allergy to the investigational agent or any agent given in association with this trial;
- Pregnant or lactating patients;
- Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) or TreponemaPallidun (TP) infection;
- Patients who are suffering from serious autoimmune disease;
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 |
|---|---|---|
| gemcitabineAlso: Gemzargemcitabine 1000mg/m2 IV on day 1 an day 8, repeat every 3 weeks | Drug | Chemotherapy, DC-CTL |
| DC-CTL8×10^9 DC-CTL cells for each infusion, IV(In the vein) for 3 cycles, each cycle received four infusions on day 14,16,30 and 32 | Biological | DC-CTL |
| cisplatinumcisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks. | Drug | Chemotherapy, DC-CTL |
Primary outcome
Progress-free survival
Time frame: 3 years
1 secondary outcome
Overall survival
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2016.
- 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.
Zi L Zhang, researcher contact
Zi L Zhang, researcher study director
Jingzhou Central 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 gemcitabine, DC-CTL and cisplatinum in people with NSCLC, run by Shenzhen Hornetcorn Bio-technology Company, LTD 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 4 inclusion and 10 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 9 May 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?
Contact Zi L Zhang, researcher (18107168013), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-free survival (time frame: 3 years). 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 9 May 2016.