Soft Tissue Sarcoma
Conditions
Interventions
Intervention Group:Immune check point inhibition therapy,Radiotherapy,Surgery
Sponsors
The First Affiliated Hospital, Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age over 18, with no gender restrictions; 2. Pathologically diagnosed as high-grade soft tissue sarcoma (G2 - 3); 3. Initial diagnosis or recurrent lesions (not having received radiotherapy, chemotherapy, or immunotherapy); 4. The baseline staging is T2 - 4/N0/M0; 5. The MDT consultation deems that preoperative radiotherapy is necessary; 6. There are chest CT examination results (excluding metastasis and interstitial lung changes); 7. There are CT or MRI examination results of the local lesion; 8. The Karnofsky performance status score is >= 70; 9. Be able to comply with the protocol during the study; 10. Sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previously undergone chemotherapy; 2. The tumor has previously received local radiotherapy; 3. Under 18 years of age; 4. With regional or distant metastasis; 5. The tumor is located in the axillary and inguinal areas; 6. Embryonal or alveolar rhabdomyosarcoma, soft tissue osteosarcoma, Ewing's sarcoma, primitive neuroectodermal tumor, Benign histological types, nodular dermatofibrosarcoma protuberans, aggressive fibromatosis; 7. Patients who are evaluated and predicted that the tumor cannot be completely and extensively resected, or are not eligible for surgical treatment; 8. Pregnant or breastfeeding women; 9. Those with a history of other malignant diseases in the past 5 years, except for cured skin cancer and cervical carcinoma in situ. 10. Those with a history of uncontrolled epilepsy, central nervous system diseases, or mental disorders, and the researcher determines that the clinical severity may prevent the signing of the informed consent form or affect the patient's compliance with oral medication; 11. Clinically severe (i.e., active) heart diseases, such as symptomatic coronary heart disease, New York Heart Association (NYHA) Class II or more severe congestive heart failure, or severe arrhythmia that requires drug intervention, or a history of myocardial infarction within the recent 12 months; 12. Those who require immunosuppressive therapy for organ transplantation and those who use hormone therapy for a long term; 13. Patients with autoimmune disorders; 14. Severely uncontrolled recurrent infections, or other severely uncontrolled concomitant disorders; 15. The baseline blood routine and biochemical indicators of the subjects fail to meet the following criteria: Hemoglobin >= 90g/L; Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Platelets >= 100 × 10^9/L; ALT and AST = 30g/L.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Shrinkage Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tumor pathological changes;Tumor microenvironment change;Surgical complications;Survival analysis; | — |
Countries
China
Contacts
Public ContactLina Zhao
The First Affiliated Hospital, Air Force Medical University
Outcome results
None listed