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Locally Advanced Soft Tissue SarcomaPhase 2NCT07156643

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.

A Phase 2 study testing Anlotinib and bempegaldesleukin in people with Locally Advanced Soft Tissue Sarcoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Locally Advanced Soft Tissue Sarcoma
What is being tested?
Anlotinib and bempegaldesleukin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
1 Oct 2025to 1 Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.
  • Any other condition deemed by the investigator to make the patient unsuitable for inclusion.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sheng Zhang contact

025-83714511

jsphkj@163.com

China1 site

  • Jiangsu Province Hospital

    Nanjing

    Sheng Zhang

Other trials in China

About this study

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.

Read the 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.

Being tested
Anlotinib and bempegaldesleukin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anlotinib and bempegaldesleukinDrug

    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.

Study groups in NCT07156643
Study groupRoleWhat they receive
Anlotinib in combination with bempegaldesleukin and conventional chemoradiotherapyExperimentalAnlotinib in combination with bempegaldesleukin and conventional chemoradiotherapy
Receives: Drug: Anlotinib and bempegaldesleukin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 years

Secondary outcomes (3)

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: 2 years

  3. 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.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2025
  2. Study start1 Oct 2025 (estimated)
  3. Primary completion1 Oct 2030 (estimated)
  4. Study completion1 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07156643
Sponsor's protocol ID
2025-SR-485
Status last verified
Aug 2025
First submitted
28 Aug 2025
Last updated
5 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib and bempegaldesleukin in people with Locally Advanced Soft Tissue Sarcoma, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sheng Zhang (025-83714511, jsphkj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07156643.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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