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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.

NCT07156643 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2025-09-05

No results posted yet for this study

Summary

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.

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Sheng Zhang · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2030-10-01
Completion
2030-10-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07156643 on ClinicalTrials.gov