Outcomes and assessments
tumor, soft-tissue sarcoma, death, Cancer
ADVERSE EVENT, TUMOR, ADVERSE EVENTS, SECONDARY, CANCER
The primary endpoint was safety of MASCT-I in combination with camrelizumab plus apatinib in patients with advanced bone and soft-tissue sarcoma. The secondary endpoints included ORR, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and immune response.Safety assessments, including monitoring for adverse events (AEs), were done from the signing of informed consent until the end of study treatment and 4 weeks after the last administration of study treatment. AEs were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The tumor response was assessed by computed tomography or magnetic resonance imaging scan every 8 weeks according to RECIST version 1.1. Survival follow-up was done 4 weeks after the study treatment, every 8 weeks for the first 3 months, and then every 12 weeks until the end of the study or death.Tumor-associated antigen specific immune response was detected by using ELISPOT (U-CyTech Biosciences, Netherlands). For patients in the schedule-I group, ELISPOT was done during the first apheresis, before the second DC cell reinfusion in the first course, before the first DC cell reinfusion in the subsequent courses, and at the end of the study treatment. For patients in the schedule-II group, ELISPOT was done during the first apheresis, before the first T cell reinfusion in the first course, before the first DC cell reinfusion in the subsequent courses, and at the end of the study treatment. The threshold for a positive response antigen was set to a net increase of 5 spots per 2 × 10