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Dendritic cell-based cancer vaccines: Current status of global clinical trials
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Abstract:
Dendritic cell (DC)-based cancer vaccines have been studied for several decades and a line of clinical trials has been completed or in process since Ralph M. Steinman, a Nobel Prize winner in Physiology or Medicine 2011, found DCs and their crucial role in adaptive immunity. Although three DC-based cancer vaccines (Sipuleucel-T, CreaVax RCC and Hybricell) have been so far approved for marketing, the DC-based immunotherapy has not yet been approved as a standard treatment for cancer. In order to make domestic peers comprehensively understood the current status of global clinical trials of DC vaccines in cancer, the general situation (regional and country distribution, involved cancer type, start year and clinical trial phase) of these clinical trials is introduced and 43 completed and published clinical trials (selecting subject, DC culturing method, vaccination schedule, effectiveness assessment method and trial result) are summarized on the basis of clinical trial registry websites accepted by International Committee of Medical Journal Editors ( ICMJE ) and PubMed web databases. Then the current development trend and existing problems of clinical trials using DC-based cancer vaccines are emphatically analyzed. Finally, several proposals to improve the clinical studies with DC vaccines against cancer are put forward as follows: perfection and refinement of our regulatory policy on clinical trials of DC-based cancer vaccines; close concern of international “in vivo DC targeting” strategy; grasping to establish DC culturing method, vaccination schedule and effect assessment standard; strengthening quality monitoring of DC-based cancer vaccines; attention to basic research and clinical trial registry of DC-based vaccines for cancer; improving the clinical trial protocols of DC-based cancer vaccines; and careful selection of subjects, effect assessment time points and synchronous application of immune monitoring during cancer treatment. The authors wish to arouse domestic peers’ attention and stimulate discussion between them, and these problems will be studied and addressed as possible as we can in the future.
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Project Supported:
Project supported by the Key New Drug Creation and Manufacturing Program of the “Eleventh Five-year Plan” of China（No. 2009zx09503-23）
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