Soft tissue sarcoma
Conditions
Interventions
experimental group:Received anlotinib hydrochloride capsules after surgery. The dose was 12mg once daily for 2 weeks and stopped for 1 week. Treatment was discontinued at 1 year or when the patient ha
Sponsors
Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with localized high-risk primary soft tissue sarcoma of the trunk and extremities as assessed by the investigator ('high-risk' definition included, but was not limited to: high-grade soft tissue sarcoma (FNCLCC grade 3); The tumor invaded deep into the fascia; The maximum diameter of tumor was >=5cm; Other patients who were considered by the investigator to be at high risk for recurrence); 2. Pathological diagnosis: undifferentiated pleomorphic sarcoma, leiomyosarcoma, myxofibrosarcoma, synovial sarcoma, angiosarcoma, malignant peripheral nerve sheath tumor, proximal epithelioid sarcoma; 3. Preoperative surgical staging: Enneking SSS stage IIA-IIB; AJCC staging (8th edition) : stage IIIA-IIIB; R0 resection was achieved. 4. Male or female patients aged >=18 years, ECOG score 3 months; 5. Laboratory tests meet the following standards: 1) blood routine examination: hemoglobin >=90g/L (no blood transfusion within 14 days); ANC>=1.5×10^9/L; PLT>=75×10^9/L; 2) biochemical examination: serum creatinine Cr 1.5 times ULN, but serum lipase within the ULN range, the patient is eligible for inclusion. 3) doppler ultrasound assessment: left ventricular ejection fraction (LVEF) >=50%. 6. Women should agree that they must use a contraceptive method (e.g. an intrauterine device (IUD), contraceptive pill, or condom) during the study and for 6 months after the study; Patients had a negative serum or urine pregnancy test within 28 days before study entry and had to be nonlactating; Men should agree to use contraception during the study period and for 6 months after the end of the study period; 7. Patients voluntarily participated in the study, signed the informed consent form, with good compliance and were able to accept the follow-up of the trial personnel.
Exclusion criteria
Exclusion criteria: 1. Patients who had received chemotherapy before surgery or received other anti-tumor therapy (including but not limited to traditional Chinese medicine with anti-tumor components such as astragalus, notoginseng, artemisinin, etc.) within 8 weeks before enrollment (Note: included subjects could receive neoadjuvant radiotherapy before surgery, but not adjuvant radiotherapy after surgery); 2. previous or concurrent malignant tumors except cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)]; 3. Participants who had participated in other drug clinical trials within 4 weeks. However, patients were eligible if they had received another study drug for more than 4 weeks. 4. Patients with NCI-CTCAE grade > 1 toxicity (except alopecia) after prior anti-cancer therapy; 5. Patients with multiple factors affecting oral medication (such as inability to swallow, Post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 6. Known space-occupying lesions of the head, carcinomatous meningitis, or severe brain or leptomeningeal diseases detected by CT or MRI at the time of screening; 7. Patients with any severe and/or uncontrolled illness, such as: 1) grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTc>=480ms), and >= grade 2 congestive heart failure (NYHA classification); Patients with myocardial infarction or severe uncontrolled arrhythmia within 6 months before enrollment; Patients with poorly controlled blood pressure (systolic blood pressure > 150mmHg, diastolic blood pressure > 100 mmHg); 2) abnormal coagulation function (INR>1.5 or prothrombin time (PT) >ULN+4 seconds or APTT >1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulant therapy; (Note: Low-dose heparin (6000-12000U per day for adults) or low-dose aspirin ( 10mmol/L); 6) patients with urinary protein >=++ and confirmed 24-hour urinary protein quantitation > 1.0g; 7) patients with seizures requiring treatment; 8) patients with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or organ transplantation; 9) renal failure requiring hemodialysis or peritoneal dialysis; 8. Long-term unhealed wounds or fractures; 9. Clinically significant hemoptysis (> 50ml/day) within 2 weeks before enrollment; Patients with clinically significant bleeding symptoms or a definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or angiitis, who were judged by the investigator to be ineligible for enrollment; 10.History of arterial/venous thrombosis events within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 11. Patients who underwent surgical resection of soft tissue sarcoma but had recurrence/metastasis before enrollment; 12. Patients with a history of psychotropic drug abuse and inability to quit or with mental disorders; 13. Concomit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-month DFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-month DFS rate;Disease Free Survival, DFS;Overall Survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactNiu Xiaohui
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed