Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT03432156
Last Updated: 2018-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
68 participants
INTERVENTIONAL
2018-04-03
2020-12-31
Brief Summary
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Detailed Description
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Lung cancer is the leading cause of cancer related deaths, which account for one third of all deaths due to cancer worldwide. The most common histologic type of lung cancer is non-small-cell lung cancer (NSCLC) that is accounting for almost 85%. There are no targeted therapeutics in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy, therefore, autologous Tcm cells immunotherapy would be a safe and effective treatment.
The aim of this study is to assess the efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy. Patients will be randomized 1:1 either to the experimental arm to receive 3 cycles of autologous Tcm cells immunotherapy or to the no intervention arm.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
No intervention group: subjects who are treated without autologous Tcm cells immunotherapy.
TREATMENT
NONE
Study Groups
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Experimental group
subjects who are treated with autologous Tcm cells immunotherapy
Autologous Tcm cells immunotherapy
Autologous Tcm cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro.
No intervention group
subjects who are treated without autologous Tcm cells immunotherapy
No interventions assigned to this group
Interventions
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Autologous Tcm cells immunotherapy
Autologous Tcm cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro.
Eligibility Criteria
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Inclusion Criteria
2. Subjects with pathologically confirmed stage II NSCLC.
3. Subjects with stage II NSCLC had treatment with surgical resection and 4 cycles of postoperative adjuvant chemotherapy before the study.
4. Karnofsky (KPS) ≥ 60.
5. One or more Serum tumor markers such as carcinoembryonic antigen (CEA), CA125, cytokeratin-19 fragment (CYFRA21-1), neuron-specific enolase (NSE), pro-grp and angiopoietin-2 (Ang-2) are double higher than normal level or durative elevator on three consecutive tests.
6. Adequate hematologic and end-organ function.
7. Subjects who could receive treatment with at least 3 cycles of autologous Tcm cells immunotherapy.
8. Subjects must be received auxiliary examination and record these results in detail before and after immunotherapy.
9. Subjects must meet the indications for autologous Tcm cells immunotherapy.
Exclusion Criteria
2. Subjects who are using immunosuppressive agents or long-term immunosuppressive agents after organ transplantation.
3. Subjects with severe abnormality of coagulation.
4. History or any evidence of hemorrhage.
5. Subjects with severe infection or high fever.
6. Subjects with severe autoimmune diseases.
7. Subjects with persistent or intractable epilepsy.
8. Subjects with merging other malignant neoplasms.
9. Subjects with mental disorder.
10. Subjects with heart, liver or kidney diseases.
11. Major surgeries except for surgical resection of NSCLC were performed in 4 weeks before the study.
12. Autologous bone marrow transplantation (ABMT) in 4 weeks before the study.
13. Concurrent treatment or treatment on another study in 4 weeks before the study.
14. Pregnancy or breast-feeding.
15. There are drug abuse, medical treatment, mental illness and social disorders that would interfere with subjects' participation, or confound the results of the trial.
16. Any condition that would interfere with or endanger the safety and compliance of subjects.
18 Years
80 Years
ALL
No
Sponsors
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Newish Technology (Beijing) Co., Ltd.
INDUSTRY
Beijing Friendship Hospital
OTHER
Responsible Party
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Jing Wang
assistant director physician
Principal Investigators
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Jing Wang
Role: PRINCIPAL_INVESTIGATOR
Beijing Friendship Hospital
Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jing Wang
Role: primary
Other Identifiers
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BeijingFH-JW-180202-1
Identifier Type: -
Identifier Source: org_study_id