Liposomal Irinotecan in Combination With Temozolomide and Bevacizumab in Patients With Advanced STS
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study ID
- NCT07457775
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Soft Tissue Sarcoma (Excluding GIST)
Eligibility Criteria
- Sex
- ALL
- Age
- 14 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- 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.
Study Details
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.
Key Dates
- Start date
- Mar 31, 2026
- Status verified
- Jan 2026
- Primary completion
- Jan 31, 2028
- Completion
- Jan 31, 2028
Study Design
- Enrollment
- 24 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Irinotecan Hydrochloride Liposome Injection（II） combined with temozolomide and bevacizumab
Primary Outcome Measure
Progression-free survival (PFS) [ Time Frame: through study completion， assessed up to 24 months ]
Central Contacts
- Ying Dong56978177