Soft Tissue Sarcoma
Conditions
Interventions
Combined neoadjuvant therapy group:neoadjuvant hypofractionated radiotherapy + in situ immunotherapy
Neoadjuvant hypofractionated radiotherapy group:neoadjuvant hypofractionated radiotherapy
Sponsors
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age >= 18 years old; (2) Patients with limb soft tissue sarcoma who were clinically diagnosed as resectable and did not receive anti-tumor treatment; (3) Combined with the imaging data within 28 days before enrollment, it was determined that surgical resection could be carried out after multidisciplinary consultation; (4) According to recistv1 1 evaluation criteria: there is at least one measurable lesion suitable for radiotherapy = 5Gy / F and intratumoral injection (the researcher determines whether it is suitable for radiotherapy and intratumoral injection); (5) The ECoG score is 0 or 1, which can tolerate the operation. (6) It has sufficient organ and bone marrow functions and meets the following requirements: 1) blood routine: neutrophil count >= 1.5 × 109 / L, hemoglobin >= 8g / dl, platelet count >= 90 × 109 / L2) liver function: total bilirubin = 50% ; (7) expected survival >= 12 weeks; (8) Women of childbearing age must have a pregnancy test (serum or urine) within 14 days before enrollment. The result is negative, and they are willing to use effective contraception during the observation period and within 3 months after the last treatment; For men, surgical sterilization should be performed or effective contraceptive methods should be agreed during the observation period and within 3 months after the last treatment; (9) Sign written informed consent and be able to follow the study protocol and follow-up process.
Exclusion criteria
Exclusion criteria: (1) Have received any kind of anti-tumor treatment within 4 weeks before enrollment, including radiotherapy, chemotherapy, molecular targeted therapy and immunotherapy (but can be enrolled if the last anti-tumor drug has been stopped for >= 5 half lives before the first treatment), or participate in another intervention clinical trial; (2) Major surgery (except minor outpatient surgery, such as placement of vascular access) was performed within 4 weeks before enrollment; Surgical fixation of the target irradiation focus and surrounding bone lesions is required, and mechanical stability is required; (3) Even after drug treatment, hypertension is still poorly controlled (continuous increase of systolic blood pressure >= 150mmhg or diastolic blood pressure >= 100mmhg); (4) Patients with uncontrolled cardiac clinical symptoms or diseases, such as 1) heart failure of nyhaii and above 2) unstable angina pectoris 3) myocardial infarction within 1 year 4) clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; (5) Having any active autoimmune disease or history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism and hypothyroidism (which can be included after hormone replacement therapy)); Patients with childhood asthma who have completely relieved and do not need any intervention or vitiligo in adults can be included, while patients who need medical intervention with bronchodilators cannot be included; (6) patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBVDNA > 500IU/ml), hepatitis C virus (hepatitis C antibody positive, and HCV-RNA above the limit of detection method) or co infection of hepatitis B and HCV. (7) Severe infection occurred within 4 weeks before the first treatment (such as intravenous infusion of antibiotics, antifungal or antiviral drugs), or fever of unknown cause occurred during screening / before the first treatment > 38.5 ?; (8) Arteriovenous thrombosis events occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, intracerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism; (9) Known to be allergic to any test drug; (10) Pregnant and lactating patients and patients with reproductive ability are unwilling to take effective contraceptive measures; (11) A clear history of neurological or mental disorders, including epilepsy and dementia; (12) Known uncontrolled or symptomatic active central nervous system (CNS) metastases, characterized by clinical symptoms, brain edema, spinal cord compression, cancerous meningitis, leptomeningeal disease and / or progressive growth; (13) Live attenuated vaccine within 4 weeks before the first administration of immune preparation or planned during the study period; (14) Before the first administration of immune preparation, there was a failure to recover to ncictcaev5 caused by previous antitumor treatment Toxicity of version 0 <= grade 1 (excluding hair loss, non clinically significant and asymptomatic laboratory abnormalities); (15) Other situations that the researcher believes are not suitable for inclusion. If accompanied by family or social factors, it will affect the safety of subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic Complete Response,pCR;Major pathological response,MPR;Dsease free survival ,DFS; | — |
Countries
China
Contacts
Public ContactRutian Li
Nanjing Drum Tower Hospital,The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed