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Trial record 13 of 4264 for:    "Carcinoma, Non-Small-Cell Lung"

Autologous Tcm Cells Immunotherapy in Patients With Non-Small Cell Lung Cancer (NSCLC)

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ClinicalTrials.gov Identifier: NCT03432156
Recruitment Status : Not yet recruiting
First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Newish Technology (Beijing) Co.,Ltd.
Information provided by (Responsible Party):
Jing Wang, Beijing Friendship Hospital

Brief Summary:
Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Biological: Autologous Tcm cells immunotherapy Phase 2

Detailed Description:

Autologous central memory T cells (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 that can improve the anti-tumor immune response and is effective treatment of the cancer. Tcm cells are effective anti-tumor immune cells that exhibit the long-term survival and self-renewal capacity in vivo. Autologous Tcm cells immunotherapy combining surgery or chemotherapy could effectively prolong survival period and improve quality of life in patients.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Experimental group: immunotherapy. subjects who are treated with autologous Tcm cells immunotherapy.

No intervention group: subjects who are treated without autologous Tcm cells immunotherapy.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Tcm Cells Immunotherapy in Patients With High-risk Recurrent Stage II Non-Small Cell Lung Cancer (NSCLC) After Postoperative Chemotherapy
Estimated Study Start Date : February 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
subjects who are treated with autologous Tcm cells immunotherapy
Biological: 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: No intervention group
subjects who are treated without autologous Tcm cells immunotherapy



Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 12 weeks ]
    This study will evaluate the clinical efficacy and safety of autologous Tcm cells immunotherapy in patients with high-risk recurrent stage II NSCLC after postoperative chemotherapy according to progression-free survival (PFS) .


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 12 weeks ]
    This study will evaluate the overall survival of patients after autologous Tcm cells immunotherapy according to Overall Survival (OS).



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be willing and able to provide written informed consent for the study.
  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:

  1. Subjects with lung nodules, lymph nodes, brain, liver, bone or adrenal metastasis before the study.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03432156


Contacts
Contact: Jing Wang +86-13801334518 wj7339@sina.com

Sponsors and Collaborators
Beijing Friendship Hospital
Newish Technology (Beijing) Co.,Ltd.
Investigators
Principal Investigator: Jing Wang Beijing Friendship Hospital

Responsible Party: Jing Wang, assistant director physician, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03432156     History of Changes
Other Study ID Numbers: BeijingFH-JW-180202-1
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jing Wang, Beijing Friendship Hospital:
immunotherapy
NSCLC

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases