The study is expected to include 24 patients with metastatic or surgically unresectable relapsed/refractory soft tissue sarcoma confirmed by histological evidence, who have received at least one line of systemic treatment previously. The efficacy and safety of liposome irinotecan combined with temozolomide and bevacizumab in the treatment of relapsed/refractory soft tissue sarcoma will be evaluated.
Age ≥14 years old, gender not limited;
For metastatic or surgically unresectable recurrent and refractory soft tissue sarcomas confirmed by histological evidence, this combination therapy regimen can be used as determined by the researcher.
Disease progression or intolerable toxicity has occurred after at least one line of systemic therapy (with or without targeted therapy) in the past.
At least one measurable lesion (RECIST v1.1);
Patients with known central nervous system metastases;
Severe gastrointestinal dysfunction (with bleeding, obstruction; inflammation above grade 2; diarrhea above grade 1);
Patients who have a history of treatment with irinotecan, temozolomide, bevacizumab or similar drugs;
Within the two weeks prior to randomization, there was third space effusion (such as a large amount of pleural effusion) that could not reach a stable state except for ascites (no intervention treatment is required after the drainage tube is removed);
Single group
Irinotecan Hydrochloride Liposome Injection(II) combined with temozolomide and bevacizuma
DrugIrinotecan Hydrochloride Liposome Injection(II) : 56.5 mg/m2, intravenous infusion for 90 minutes (+30 minutes), day 1, 3 weeks as one study cycle; Clotemozolomide: 100 mg/m2/day × 5 days, with 3 weeks as one study cycle; Bevacizumab: 7.5 mg/kg, intravenous infusion, 1 day, 3 weeks as one study cycle.
Progression-free survival (PFS)
Progression-free survival (PFS) is a measure used in clinical trials and medical research to evaluate the effectiveness of treatments, especially in oncology. It refers to the length of time during and after treatment that a patient lives with a disease without it getting worse. In other words, PFS is the duration from the start of treatment until the disease progresses or until the patient dies from any caus，whichever came first, assessed up to 24 months
Safety-Adverse events (AE)
Adverse events (AE)/serious adverse events (SAE) (judged based on NCI-CTCAE 5.0), etc.
Objective response rate (ORR)
From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
12-week PFS rate
the percentage of patients who remain progression-free after 12 weeks treatment
overall survival
From the date of enrollment until the date of death from any cause or the end of the study, whichever came first, assessed up to 24 months
Disease Control Rate (DCR）
From the date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
