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.

Not Applicable

Not yet recruiting

• Conditions: Locally Advanced Soft Tissue Sarcoma
• Interventions: Drug: Anlotinib and bempegaldesleukin

• Registration Number: NCT07156643
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

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 Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-28
• Study First Submitted QC: 2025-08-28
• Last Update Submitted: 2025-08-28
• Study First Posted: 2025-09-05
• Last Update Posted: 2025-09-05
• Study Start: 2025-10-01
• Primary Completion: 2030-10-01
• Study Completion: 2030-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Age: 18 to 80 years.
2. 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.
3. Measurable Disease: At least one measurable or evaluable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
4. Life Expectancy: ≥ 3 months.
5. Performance Status: Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
6. 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.
7. 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.
8. Treatment Plan and Consent: The investigator plans to administer the combined chemoradiotherapy and targeted immunotherapy regimen, and the patient has provided written informed consent.

Exclusion Criteria

1. Prior treatment with PD-1/PD-L1/CTLA-4 antibodies, radiotherapy, or any targeted therapy.
2. Tumor invasion of major blood vessels.
3. Active, known, or suspected autoimmune disease.
4. Known history of primary immunodeficiency.
5. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
6. Pregnant or lactating female patients.
7. 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).
8. Current participation in another drug clinical trial.
9. Any other condition deemed by the investigator to make the patient unsuitable for inclusion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anlotinib in combination with bempegaldesleukin and conventional chemoradiotherapy	Anlotinib and bempegaldesleukin	Anlotinib in combination with bempegaldesleukin and conventional chemoradiotherapy

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Progression-free Survival（PFS）	2 years	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.
Overall Survival（OS）	2 years	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.
Disease control rate（DCR）	2 years	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.

Trial Locations

Locations (1)

Jiangsu Province Hospital; 🇨🇳 Nanjing, China