This study will evaluate the safety and preliminary efficacy of Multi-Antigen Stimulated Cell Therapy-I Injection (MASCT-I) in combination with Apatinib and/or Camrelizumab in patients with advanced bone and soft-tissue sarcoma.
This is a single-center, open-label, exploratory study to evaluate the safety, preliminary efficacy and immune response of MASCT-I with Apatinib and/or Camrelizumab in the treatment of patients with advanced bone and soft-tissue sarcoma. 60 patients with advanced bone and soft-tissue sarcoma will be recruited. This study include two parts. In part A, patients were randomized into two groups: one group received MASCT-I A+Camrelizumab+Apatinib, and the other group received MASCT-I B +Camrelizumab+Apatinib, the administration schedules for MASCT-I is different between two groups. A total of 20 patients were planned to be recruited in part A. In part B, patients will be treated with MASCT-I (based on the administration schedule selected from part A) in combination with Apatinib. 40 patients were planned to be recruited in part B. MASCT-I A and MASCT-I B were administered mainly at different frequencies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Multi-Antigen Stimulated Cell Therapy-I Injection (MASCT-I) is a sequential immune cell therapy. Camrelizumab is an immune checkpoint inhibitors against PD-1. Apatinib is a highly selective tyrosine kinase inhibitor targeting VEGFR2.
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGAdverse events and serious adverse events (safety)
All adverse events and serious adverse events during the study
Time frame: 4 years
Objective Response Rate (ORR)
The percentage of participants with complete response (CR) or partial response (PR) via investigator assessment per RECIST (Response Evaluation Criteria In Solid Tumors Criteria) v1.1 relative to the total number of participants in the analysis population.
Time frame: 4 years
Progression-Free Survival (PFS)
The time from the date of randomization to the first occurrence of radiological progression or death, whichever comes first.
Time frame: 4 years
Disease Control Rate (DCR)
The percentage of participants with CR, PR, or stable disease (SD) relative to the total number of participants within the analysis population as determined by Investigators per RECIST v1.1.
Time frame: 4 years
Overall Survival (OS)
The interval of time between the date of enrollment and the date of death.
Time frame: 4 years
immune response
Specific immune responses to tumor-associated antigens were detected at different time points according to different administration schedules.
Time frame: 4 years
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