A Prospective, Single-arm, Multicenter Exploratory Clinical Study of Anlotinib Combined With Bempegaldesleukin and Conventional Chemoradiotherapy for the Treatment of Unresectable Locally Advanced or Metastatic Soft Tissue Sarcoma.

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

October 1, 2025

Primary Completion Date

October 1, 2030

Study Completion Date

October 1, 2030

Conditions
Locally Advanced Soft Tissue Sarcoma
Interventions
DRUG

Anlotinib and bempegaldesleukin

"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."

Trial Locations (1)

Unknown

Jiangsu Province Hospital, Nanjing

All Listed Sponsors
collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

lead

The First Affiliated Hospital with Nanjing Medical University

OTHER