Patients and treatment plans
A total of 68 patients were selected with advanced solid tumors
(including 42 lung cancers, 14 liver cancers, 9 colon cancers and 3
renal carcinomas) who had experienced disease progression after at least
one previous course of tumor-appropriate treatment for advanced or
metastatic disease. Other inclusion criteria included stopping any
cancer therapy before enrollment, an age of 18 to 75 years, a life
expectancy greater than 12 weeks, an Eastern Cooperative Oncology Group
(ECOG) performance status of 0 or 1, adequate organ function, and
lesions that could be evaluated using the Response Evaluation Criteria
in Solid Tumors (RECIST) guidelines. The following exclusion criteria
were applied: previous treatment with anti-CTLA-4 or anti-PD-1/PD-L1
therapy, any form of primary immunodeficiency or history of autoimmune
disease, ongoing systemic infections and concurrent systemic steroid
therapy, and recruitment into other clinical trials. All participating
patients provided informed consent.
This open-label, phase I & II trial was approved by the Review Board
and Clinical Research Ethics Committee of The First Affiliated Hospital
of Guangzhou Medical University. It’s registered atwww.chictr.org.cn.(ChiCTR-OIC-17011679). All methods and procedures employed by this study
were performed in accordance with Good Clinical Practice guidelines and
were in accordance with the principles of the Declaration of Helsinki
and local laws. All authors had access to the study data and reviewed
and approved the final manuscript. The enrolled patients received
intravenous infusions of autologous CIK cells. All participants received
at least eight cycles of infusions (four cycles at weekly intervals
followed by four cycles every 2 weeks) or received cycles until they
experienced disease progression or unacceptable adverse events (AEs) or
withdrew consent. Patients with disease progression were removed from
the study and then received multidisciplinary synthetic therapy or were
recruited into other clinical trials according to the recommendations of
physicians. If the patients had an objective response or stable disease
after treatment, they were viewed as eligible to receive additional
cycles of maintenance treatment every 2 weeks. The design and procedures
used in the clinical trial are shown in Figure 1.