New cocktail of drugs and radiation takes on Hard-to-Treat sarcoma
NCT ID NCT07156643
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase 2 trial tests whether combining two drugs (anlotinib and bempegaldesleukin) with standard radiation and chemotherapy can shrink or control advanced soft tissue sarcoma that cannot be surgically removed. About 46 adults aged 18 to 80 will receive the treatment in two phases: first with radiation, then with chemotherapy as maintenance. The main goal is to see how many patients' tumors shrink significantly.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- anlotinib and bempegaldesleukin
- What this could lead to
- If successful, this combination could offer a new treatment option to shrink or control advanced soft tissue sarcoma that cannot be removed by surgery.
- What could go wrong
- This is an early-phase, small trial (46 people) with no comparison group. The drugs may cause side effects, and the approach may not work for all sarcoma types.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2025
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Jiangsu Province Hospital
Nanjing, China
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