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.