Soft tissue sarcoma
Conditions
Interventions
Experimental Group:A 21-day cycle of irinotecan liposome (II) + temozolomide + bevacizumab was administered until disease progression or intolerable toxicity.
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
14 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 14 years old, gender not restricted; 2. Metastatic or unresectable recurrent refractory soft tissue sarcoma confirmed by histological evidence, and the combination treatment regimen can be used as judged by the investigator; 3. Disease progression or intolerable toxicity occurred after at least one line of systemic treatment (with or without targeted therapy) in the past. 4. At least one measurable lesion (RECIST v1.1); 5. ECOG: 0-2; 6. Expected survival >= 3 months; 7. Good function of major organs, that is, meeting the following criteria (within 14 days before randomization, no blood components or cell growth factors were received): (1) Neutrophils >= 1.5 * 10^9/L; Platelets >= 80 * 10^9/L; Hemoglobin >= 9 g/dl; Serum albumin >= 3 g/dl; (2) Total bilirubin = 60 ml/min; (4) INR = 50%; 8. Pregnant women must undergo a blood pregnancy test 3 days before randomization, and the result must be negative, and are willing to use appropriate methods of contraception during the trial and within 6 months after the end of the treatment. For men, they should agree to use appropriate methods of contraception during the study and within 3 months after the end of the treatment; 9. Participants voluntarily join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with known central nervous system metastases; Those who have acquired immunodeficiency syndrome (AIDS) or have tested positive for HIV; 17. Those with active syphilis infection; 18. Those with a clear history of neurological or mental disorders, including epilepsy or dementia; 19. As determined by the investigators, the subjects have other factors that may cause them to be forced to terminate the study prematurely, such as non-compliance with the protocol, having other serious diseases (including mental disorders) that require combined treatment, having severely abnormal laboratory test values with clinical significance, family or social factors that may affect the safety of the subjects or the collection of trial data, etc.2. Severe gastrointestinal dysfunction (bleeding, obstruction, > grade 2 inflammation, > grade 1 diarrhea); 3. Patients with previous treatment history of irinotecan, temozolomide, bevacizumab or similar drugs; (4) The presence of third-space effusion (e.g., massive pleural effusion) other than ascites that could not reach a stable state (no intervention after drainage removal) within 2 weeks before randomization; 5. Patients with symptomatic ascites, requiring puncture or drainage, or patients with ascites drainage within the past 3 months (except those with small and controllable ascites on imaging, but without clinical symptoms); 6. Current interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring steroid therapy, or other pulmonary fibrosis, organizing pneumonia (e.g., Bronchiolitis obliterans), pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia, or active pneumonia or severely impaired lung function on chest CT during the screening period; Active tuberculosis; 7. Presence of active autoimmune disease or a history of autoimmune disease with potential recurrence (including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (eligible if controlled only with hormone replacement therapy); Patients with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, controlled type I diabetes treated with insulin, or asthma that had been completely relieved in childhood without any intervention in adulthood were eligible. 8. Known peripheral neuropathy (CTCAE>= grade 3); 9. Known dihydropyrimidine dehydrogenase (low activity) or deficiency; 10. Severe infection (CTCAE > 2) within 4 weeks before randomization, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc. Signs and symptoms of infection requiring treatment with intravenous antibiotics (except prophylactic antibiotics) within 2 weeks before randomization were present. 11. Received any of the following concomitant medication that contained a strong inhibitor/strong inducer of CYP3A4, CYP2C8, or a strong inhibitor of UGT1A1 within 2 weeks before randomization; The use of immunosuppressive agents or systemic steroids for immunosuppression within 2 weeks before randomization (prednisone at a dose of >10mg/ day or other equivalent steroids); Had received radiation therapy within 2 weeks before randomization; Major surgery (e.g., thoracotomy, laparotomy, etc.) within 4 weeks before randomization; Any other investigational drug was received within 4 weeks before randomization, unless it was part o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival;Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Overall survival ;Disease control rate;Duration of relief;12-week PFS rate; | — |
Countries
China
Contacts
Public ContactDong Ying
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed