Soft tissue sarcoma
Conditions
Interventions
treatment group:Chemotherapy (epirubicin+ifosfamide)
surgery
Radiotherapy
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males or females aged >=18 years; 2. ECOG performance status =6 months; 4. Patients with pathologically confirmed stage II-III STS (according to the 8th edition of the American Joint Committee on Cancer [AJCC] staging); 5. STS with T stage >=2 and grade 2-3 (FNCLCC); 6. Tumor area has not previously received radiotherapy; 7. According to RECIST v1.1 criteria, at least one measurable lesion exists, with baseline measurement by CT or MRI (preferably with intravenous contrast) showing a sum of the longest diameters >=10 mm (excluding lymph nodes; lymph nodes must have a short axis >=15 mm), and lesions suitable for repeated accurate measurement; 8. Blood routine tests: Hemoglobin (Hb) >=80 g/L (no transfusion within 14 days); absolute neutrophil count (NEUT) >=1.5×10^9/L; platelets (PLT) >=75×10^9/L; 9. Biochemistry tests: ALT and AST 50 µmol/L; 10. Coagulation function: APTT, INR, and PT <=1.5×ULN; 11. Female patients must agree to use contraception during the study and for 6 months after the study (e.g., IUD, oral contraceptives, or condoms); have a negative serum or urine pregnancy test within 7 days before enrollment, and must not be breastfeeding; male patients must agree to use contraception during the study and for 6 months after the study; 12. Patients voluntarily participate in this study, sign the informed consent form (ICF), and are able to comply with the visit schedule and procedures.
Exclusion criteria
Exclusion criteria: 1. Because the tumor enrolled this time has received previous anthracycline-containing treatment and is confirmed to be ineffective; 2. Received any investigational drug within 28 days prior to the administration of this regimen; 3. Received systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory drugs (including thymus peptide, interferon, interleukin) within 2 weeks before the first dose; 4. Is participating in another interventional clinical study, or is in the follow-up phase of the interventional study 5. Known central nervous system (CNS) metastases and/or spinal cord compression and/or carcinomatous meningitis, with a history of leptomeningeal cancer. Patients with stable symptoms after radiotherapy or surgery with brain metastases may participate in this study as long as they meet all of the following criteria: measurable lesions outside the central nervous system: no midbrain, pons, meninges, bulbar or spinal cord metastases; No evidence of new or enlarging brain metastases after treatment of brain metastases and discontinuation of corticosteroid and anticonvulsant drug therapy for at least 14 days prior to study treatment may be enrolled; Patients with asymptomatic brain metastases who need radiotherapy for brain metastases can be enrolled in the study if they meet the above conditions after treatment: 6. Have undergone major surgical surgery (craniotomy, thoracotomy or laparotomy or other as defined by the investigator) within 4 weeks prior to the first dose of study drug, or have unhealed wounds, ulcers or fractures. Note: For the purpose of palliative care, local surgical treatment of isolated lesions is acceptable; 7. Uncontrolled intercurrent diseases, such as: · Serious infection within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia; HIV-infected (HIV 1/2 antibody positive); Symptomatic congestive heart failure (New York Heart Association class II-IV) or LVEF (left ventricular ejection fraction) <50% on cardiac ultrasound, or poorly controlled arrhythmias; History of myocarditis; Esophageal or gastric varices requiring immediate intervention (e.g., banding or sclerotherapy) or evidence of portal hypertension. In the opinion of the investigator or in consultation with a gastroenterologist or hepatatologist, the risk of bleeding is high; Have had any arterial thromboembolism within 6 months prior to enrollment treatment, including myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack, etc.; Any life-threatening bleeding event within 3 months prior to enrollment in the study that requires medical intervention such as: blood transfusion therapy, surgical or local therapy, continuous medication and other treatments; Uncontrolled metabolic disorders or other non-malignant neoplastic organs or systemic diseases or secondary reactions to cancer, and can lead to higher medical risk and/or uncertainty in survival evaluation, and are judged by the investigator to be unsuitable for enrollment or have other conditions judged by the investigator to be unsuitable for enrollment; History of gastrointestinal perforation and/or fistula within 6 months prior to study enrollment; Patients at risk of intestinal obstruction (excluding surgically cured intestinal obstruction) or intestinal perforation (including but not limited to acute diverticuli
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major pathological response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local control rate;Disease-free survival;overall survival; | — |
Countries
China
Contacts
Public ContactJiayong Liu
Peking University Cancer Hospital
Outcome results
None listed