Small Cell Lung Cancer Clinical Trial
Official title:
A Randomized, Controlled, Open-label, Single Center, Phase II Study to Evaluate the Efficacy and Safety of NK Cell-based Immunotherapy as Maintenance Therapy for Patients With Small-cell Lung Cancer After First-line Chemotherapy.
Natural killer (NK) cells can kill a broad array of tumor cells in a non-major histocompatibility complex(MHC)-restricted manner. Adoptive transfer of NK may prolong the survival of patients with cancer. This study evaluates the efficacy and safety of NK cell-based immunotherapy for small-cell lung cancer (SCLC) after first-line chemotherapy. Half of the participants will receive autologous adoptive transfer of NK cells after the response from first-line chemotherapy, while the other half will be followed up in routine clinal practice.
The small-cell lung cancer (SCLC) is very sensitive to the standard-of-care first-line
chemotherapy and/or radiotherapy, but it will ultimately progress or relapse and develop
early resistance to conventional treatments. No effective maintenance therapy except for wath
and wait after first-line therapy at present.
NK cells constitute the major component of the innate immune system and kill tumor cells in a
non-MHC-restricted manner. In our previous pilot study and other reports, adoptive transfer
of autologous NK cells expanded ex vivo was very well tolerant and effective.
There is no prospective trial on the maintenance therapy of SCLC after first-line
chemotherapy based on autologous NK cells. The purpose of this phase II clinical research is
to evaluate the efficacy and safety of autologous NK cells as the maintenance therapy after
the first-line treatment, comparing with conventional observation group.
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