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
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Non-Small-Cell Lung||Biological: Autologous Tcm cells immunotherapy||Phase 2|
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|
|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)|
|Official Title:||Autologous Tcm Cells Immunotherapy in Patients With High-risk Recurrent Stage II Non-Small Cell Lung Cancer (NSCLC) After Postoperative Chemotherapy|
|Anticipated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
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
- 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) .
- 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).
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
|Contact: Jing Wangfirstname.lastname@example.org|
|Principal Investigator:||Jing Wang||Beijing Friendship Hospital|