Soft Tissue Sarcoma
Conditions
Interventions
Experimental group:Lurbinectedin combined with doxorubicin plus PD-1 inhibitor and regorafenib
Sponsors
Cancer Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 16-75 years. 2. Histologically confirmed diagnosis of soft tissue sarcoma. 3. No previous systemic therapy. Except progression or metastases more than 6 months after adjuvant or neoadjuvant chemotherapy. 4. ECOG PS 0-1. 5. Radiologically measurable disease according to the RECIST v.1.1. 6. Expected survival =3 months. 7. Adequate organ function should meet the following criteria 7-14 days before treatment: (1) Hemoglobin = 90 g/L; absolute neutrophil count (ANC) = 1.5 x 109/L, and platelet count = 80 x 109/L. (2) Total bilirubin = 1.5 x ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 x ULN, ALT and AST = 5 x ULN if with liver metastases; Cr = 1.5 x ULN or CCr =50ml/min; UPRO < 2+ or 24-hour urinary protein quantity < 1g. (3) LVEF = LLN(50%) 8. Female subjects should be consenting to use at least one medically approved contraceptive method during the study treatment period and for 6 months after the end of the study treatment period. A blood pregnancy test must be negative within 7 days prior to study enrollment. 9. Willing and able to follow trial and take oral medication. 10. Voluntarily agree to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Have received prior anti-cancer treatment, if the patient has received adjuvant or neoadjuvant chemotherapy and developed metastases within 6 months after the end of this therapy, the patient is considered to have received one type of past chemotherapy regimen for metastases. 2. Currently or previously diagnosed with other malignancies (excluding adequately treated basal cell carcinoma or squamous cell carcinoma, carcinoma in situ of the cervix, superficial bladder cancer, in situ prostate cancer, in situ breast cancer), unless curative treatment has been performed and there is no evidence of recurrence or metastasis within the past five years. 3. Symptoms accompanied with pleural effusion or ascites, causing respiratory syndrome (=CTC AE grade 2 dyspnea [grade 2 dyspnea refers to shortness of breath during a small amount of activity; affecting instrumental activities of daily living]), and cannot be controlled by symptomatic treatment. 4. Active central nervous system (CNS) metastases with clinical symptoms including cerebral edema, steroid requirements, or progressive disease. 5. Has a history of interstitial lung disease, severely impaired lung function, severe pulmonary fibrosis, radiation pneumonitis, drug-induced lung disease, and evidence of active pulmonary inflammation as shown by chest CT scan results during the screening period. 6. Patients whose imaging examination during the screening period shows that the tumor has invaded around important blood vessels or the researcher judges that the tumor is very likely to invade important blood vessels and cause massive bleeding during the trial. 7. Patients who are allergic to any component or excipient of the trial drug or have contraindications due to allergic reaction histories to compounds with similar chemical or biological components to Lurbinectedin, Doxorubicin, Regorafenib, and PD-1 inhibitors. 8. Received major surgical surgery (such as craniotomy, thoracotomy or laparotomy) within 28 days before the first use of the drug or had serious unhealed wounds, ulcers or fractures at the time of screening. 9. Patients with any severe and/or uncontrolled medical condition, including: (1) Patients with unsatisfactory blood pressure control (systolic blood pressure =150 mmHg, diastolic blood pressure =100 mmHg); (2) Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QTC =480ms) and grade =2 congestive heart failure (New York Heart Association (NYHA) classification); (3) Active or uncontrolled serious infection (=CTC AE grade 2 infection); (4) Liver cirrhosis, decompensated liver disease, active hepatitis, chronic hepatitis, hepatitis B HBV-DNA quantitative titer is greater than 2000IU/mL, active hepatitis C HCV RNA is positive; (5) Renal failure requiring hemodialysis or peritoneal dialysis; (6) Poorly controlled diabetes (fasting blood glucose (FBG) >10mmol/L); (7) Urine routine shows urine protein =++, and the 24-hour urine protein quantity is confirmed to be >1.0 g; (8) Have a history of psychotropic drug abuse and are unable to abstain or have mental disorders 10. Patients who have epileptic seizures and need treatment. 11. Patients who have any bleeding or bleeding events = NCI CTCAE v5.0 grade 2 within 4 weeks before the first administration; patients who have experienced cerebrovascular accidents, deep vein thrombosis and pulmonary embolism within 6 months before the first administration. 12. Use of immunosuppressive drugs wit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;6 months Progression Free Survival Rate;Overall Survival;Disease Control Rate;Duration of Response;Safty;Biomarkers; | — |
Countries
China
Contacts
Public ContactLiu yutao
Cancer Hospital Chinese Academy of Medical Sciences
Outcome results
None listed