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 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-SR-485
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• Progression-free Survival（PFS）

  2 years

• Overall Survival（OS）

  2 years

• Disease control rate（DCR）

  2 years

Other Outcomes (1)

• Number of Safety Events

  2 years

Study Arms (1)

Anlotinib in combination with bempegaldesleukin and conventional chemoradiotherapy

EXPERIMENTAL

Anlotinib in combination with bempegaldesleukin and conventional chemoradiotherapy

Drug: Anlotinib and bempegaldesleukin

Interventions

Anlotinib and bempegaldesleukin DRUG

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.

Anlotinib in combination with bempegaldesleukin and conventional chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 80 years.
• Diagnosis: Pathologically confirmed, investigator-assessed metastatic or unresectable locally advanced soft tissue sarcoma, classified as Stage IV according to the AJCC (8th Edition) staging system. Eligible histologic subtypes per the WHO (2013) classification include anthracycline-insensitive types, primarily: myxoid/round cell liposarcoma, Grade 1 dedifferentiated liposarcoma, clear cell sarcoma, endometrial stromal sarcoma, alveolar soft part sarcoma, extraskeletal myxoid chondrosarcoma, osteosarcoma, chondrosarcoma, Ewing sarcoma/primitive neuroectodermal tumor (PNET), embryonal rhabdomyosarcoma, alveolar rhabdomyosarcoma, gastrointestinal stromal tumor (GIST), etc. Eligibility of other rare soft tissue sarcoma subtypes will be determined by the investigator.
• Measurable Disease: At least one measurable or evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Life Expectancy: ≥ 3 months.
• Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Adequate Organ Function: Must meet the following criteria within 7 days prior to treatment initiation:1）Hematological (without transfusion or use of growth factors within 14 days):Hemoglobin (Hb) ≥ 90 g/L,Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹/L,Platelet count (PLT) ≥75×10⁹/L;Biochemical:Total Bilirubin (TBIL) ≤1.5 × Upper Limit of Normal (ULN),Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST)≤ 2.5× ULN,Serum Creatinine (Cr)≤ 1.5 × ULN or Creatinine Clearance (CrCl) ≥ 60 mL/min,Urinalysis: Urine protein\< 2+ and 24-hour urine protein quantification must show protein≤1 g;Coagulation: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN;Cardiac Function: Left Ventricular Ejection Fraction (LVEF) ≥ 50% as assessed by Doppler ultrasound;Thyroid Function: Thyroid-Stimulating Hormone (TSH) ≤ 2.0 × ULN; if abnormal, T3 and T4 levels must be within normal limits for enrollment.
• Contraception: Women of childbearing potential must have used reliable contraception, have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and be willing to use adequate contraception during the trial and for 8 weeks after the last dose of the study drug. Men must agree to use adequate contraception or be surgically sterile during the trial and for 8 weeks after the last dose.
• Treatment Plan and Consent: The investigator plans to administer the combined chemoradiotherapy and targeted immunotherapy regimen, and the patient has provided written informed consent.

You may not qualify if:

• Prior treatment with PD-1/PD-L1/CTLA-4 antibodies, radiotherapy, or any targeted therapy.
• Tumor invasion of major blood vessels.
• Active, known, or suspected autoimmune disease.
• Known history of primary immunodeficiency.
• History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Pregnant or lactating female patients.
• Uncontrolled concurrent illnesses, including but not limited to:HIV infection (HIV antibody positive).Active or clinically poorly controlled severe infection.Active hepatitis.Evidence of severe or uncontrolled systemic diseases (e.g., severe psychiatric, neurological, epileptic, or dementia disorders; unstable or decompensated respiratory, cardiovascular, hepatic, or renal diseases; uncontrolled hypertension \[defined as ≥ Grade 2 hypertension per CTCAE despite medical therapy\]).Active bleeding or newly diagnosed thrombotic disease requiring therapeutic anticoagulation, or bleeding tendency; coagulation abnormalities (INR \> 1.5 × ULN, APTT \> 1.5 × ULN).
• Current participation in another drug clinical trial.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (1)

Jiangsu Province Hospital

Nanjing, China

Location

MeSH Terms

Interventions

anlotinib; bempegaldesleukin

Study Officials

• Sheng Zhang

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sheng Zhang

CONTACT

025-83714511; jsphkj@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)