This study employs a multicenter, single-arm trial design. Participants will receive a treatment regimen consisting of "anlotinib plus bempegaldesleukin concurrent with radiotherapy," followed by a maintenance therapy phase of "anlotinib plus bempegaldesleukin concurrent with chemotherapy." The study aims to evaluate the clinical efficacy and safety of anlotinib in combination with bempegaldesleukin and conventional chemoradiotherapy for the treatment of unresectable locally advanced or metastatic soft tissue sarcoma.
This multicenter, single-arm study is designed to enroll 46 patients with metastatic or unresectable locally advanced soft tissue sarcoma. Participants will receive a treatment regimen consisting of "anlotinib plus bempegaldesleukin concurrent with radiotherapy," followed by a maintenance phase of "anlotinib plus bempegaldesleukin concurrent with chemotherapy." The primary endpoint is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and safety. The study aims to evaluate the clinical efficacy and safety of anlotinib in combination with bempegaldesleukin and conventional chemoradiotherapy for the treatment of this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Subjects will receive concurrent anlotinib, bempegaldesleukin, and radiotherapy, followed by maintenance therapy with anlotinib, bempegaldesleukin, and chemotherapy. Concurrent Radiotherapy Phase: Anlotinib: 10 mg orally once daily on days 1-14, every 3 weeks (q3w), for 2 cycles during radiotherapy. Bempegaldesleukin: 1200 mg IV on day 1, q3w, for 2 cycles during radiotherapy. Radiotherapy: Delivered once daily, with a total biological effective dose (BED) of 36-100 Gy. Techniques may include conventional fractionation or stereotactic body radiotherapy (SBRT), as determined by the investigator. Maintenance Phase: Chemotherapy: Doxorubicin 40 mg/m² IV day 1 + ifosfamide 1.2-2.4 g/m² IV days 1-5 per 21-day cycle for 4-6 cycles. Anlotinib: 10 mg orally once daily on days 1-14, q3w. Bempegaldesleukin: 1200 mg IV on day 1, q3w.
Jiangsu Province Hospital
Nanjing, China
Objective Response Rate (ORR)
Objective Response Rate (ORR) refers to the proportion of patients in whom tumor burden decreases by a predefined amount and remains reduced for a minimum time period. It encompasses both Complete Response (CR) and Partial Response (PR) cases. Tumor response is evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: 2 years
Progression-free Survival(PFS)
Progression-Free Survival (PFS) is defined as the time from the date of the first administration of the study drug to the date of disease progression or death from any cause, whichever occurs first.
Time frame: 2 years
Overall Survival(OS)
Overall Survival (OS) is defined as the time from the date of the first administration of the study drug to the date of death from any cause.
Time frame: 2 years
Disease control rate(DCR)
Disease Control Rate (DCR) refers to the proportion of patients in whom tumor burden decreases or remains stable according to predefined criteria, sustained for a minimum specified duration. It encompasses cases achieving Complete Response (CR), Partial Response (PR), and Stable Disease (SD). Tumor response is evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Time frame: 2 years
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