In this study, a new post-processing image technology - radiomics is used to screen out parameters of CT and MRI images, which could effectively evaluate the efficacy and prognosis of immunotherapy plus targeted therapy for soft tissue sarcoma (STS). A reliable and effective model for predicting the prognosis of STS will be established based on the radiomic parameters combined with traditional imaging, histophiological, whole exome sequencing (WES) results, inflammatory indicators and changes in the number and function of lymphocyte subsets before and after medication. Patients with advanced STS who may benefit from the combination therapy can be found out by this model.
Male or female subjects aged from 18 to 75 years old;
Subjects with histologically confirmed unresectable locally advanced or metastatic soft tissue sarcoma, which includes synoviosarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, fibrosarcoma, epithelioid sarcoma, angiosarcoma, alveolar soft-part sarcoma, etc. Chondrosarcoma, osteosarcoma, dermatofibrosarcoma protuberans, gastrointestinal stromal tumor and malignant mesothelioma are excluded;
Patients who agree to receive small molecule multi-target TKI and anti-PD-1 or anti-PD-L1 monoclonal antibody therapy, without contraindications in the use of related drugs;
Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Previously irradiated focus can be considered as measurable only if there is definite progress after radiotherapy;
Patients whose tumors are judged by the investigators to be at high risk of invading vital blood vessels and causing fatal hemorrhage during the study.
Occurrence of arterial/venous thrombotic events within 6 months before treatment, such as cerebrovascular accident (including transient ischemic attack, hematencephalon and cerebral infarction), deep vein thrombosis , pulmonary embolism, etc.
Occurrence of clinically significant hemoptysis(>5ml fresh blood in 4 weeks), hemorrhagic tendency(bleeding>30ml within 3 months), such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood test(FOBT) ++ in the baseline period , or vasculitis, etc;
Hypertension that cannot be controlled stably by drugs, which is defined as: systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg;
Patients with advanced soft tissue sarcoma receiving immunotherapy plus targeted therapy
Cohort
Prospective
Not listed
The accuracy of Geno-radiomics-based model for response evaluation of immunotherapy and targeted therapy for advanced soft tissue sarcoma
Receiver operating characteristic (ROC) curves and area under the curve (AUC) are used to evaluate the accuracy of the model
The accuracy of Geno-radiomics-based model for predicting prognosis of immunotherapy and targeted therapy for advanced soft tissue sarcoma
ROC curves and AUC are used to evaluate the accuracy of the model
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