Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Advanced STS (NCT07457775) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Advanced STS
China24 participantsStarted 2026-03-31
Plain-language summary
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.
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. 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);
✓. ECOG: 0-2;
✓. Expected survival period ≥3 months;
✓. Good function of major organs, that is, meeting the following criteria (without receiving any blood components or cell growth factors within 14 days prior to randomization) :
Exclusion criteria
✕. Patients with known central nervous system metastases;
✕. 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);
What they're measuring
1
Progression-free survival (PFS)
Timeframe: through study completion， assessed up to 24 months
2
Safety-Adverse events (AE)
Timeframe: through study completion，assessed up to 24 months
Trial details
NCT IDNCT07457775
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
. Patients with ascites with clinical symptoms who require puncture or drainage, or those who have received ascites drainage within the past 3 months (except for those with only a small amount of ascites shown on imaging and controllable, but without clinical symptoms);
✕. Currently accompanied by interstitial pneumonia or interstitial lung disease, or those with a history of interstitial pneumonia or interstitial lung disease requiring hormone therapy in the past, or other conditions that may interfere with the judgment and management of immune-related lung toxicity such as pulmonary fibrosis or organizing pneumonia (for example, Subjects with obliterative bronchiolitis, pneumoconiosis, drug-related pneumonia, idiopathic pneumonia, or those with active pneumonia or severely impaired lung function as shown by chest CT during the screening period; Active tuberculosis
✕. Subjects with active autoimmune diseases or a history of autoimmune diseases that may relapse \[including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism (subjects that can be controlled only through hormone replacement therapy can be enrolled)\]; Those with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, alopecia, controlled type 1 diabetes treated with insulin, or childhood asthma that has been completely relieved and does not require any intervention in adulthood can be enrolled.
✕. Known peripheral neuropathy (CTCAE≥ grade 3);