New combo therapy aims to tackle tough sarcomas
NCT ID NCT07342322
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a new treatment for soft tissue sarcoma that combines a special type of radiation with immunotherapy and immune-boosting drugs. The goal is to see if this combination can shrink tumors and improve outcomes for people with advanced or recurrent sarcoma. The study plans to enroll 25 participants and is not yet recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab (an immunotherapy drug) combined with spatially fractionated radiotherapy and immune-boosting drugs (GM-CSF and thymalfasin)
- What this could lead to
- If successful, this could offer a new treatment option for people with advanced soft tissue sarcoma that cannot be removed by surgery.
- What could go wrong
- This is a small, early-phase trial with only 25 people, so results may not apply to everyone. The combination therapy may cause significant side effects, and it is not yet known if it will improve survival.
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 25 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
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 75 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: 18-75 years old, both genders are eligible. 2. Pathological Diagnosis: Histologically confirmed soft tissue sarcoma, including but not limited to: * Undifferentiated pleomorphic sarcoma * Liposarcoma * Leiomyosarcoma * Synovial sarcoma * Fibrosarcoma * Other high-grade soft tissue sarcomas 3. Disease Stage: * Locally advanced, unresectable soft tissue sarcoma, or * Recurrent or metastatic soft tissue sarcoma 4. Prior Therapy: * Prior surgery, radiotherapy, or chemotherapy is allowed. * At least 4 weeks since the last anti-tumor treatment. * Prior treatment-related toxicities have resolved to ≤Grade 1 (except alopecia). 5. Measurable Disease: At least one measurable lesion according to RECIST 1.1 criteria. 6. Performance Status: ECOG performance status score of 0-2. 7. Life Expectancy: ≥3 months. 8. Organ Function: * Hematology: Hemoglobin ≥50 g/L, absolute neutrophil count ≥1.5×10⁹/L, platelet count ≥60×10⁹/L * Liver Function: Total bilirubin ≤1.5× upper limit of normal (ULN), ALT and AST ≤2.5× ULN (≤5× ULN for patients with liver metastasis) * Renal Function: Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 mL/min * Cardiac Function: Left ventricular ejection fraction ≥40% 9. Informed Consent: The patient or their legal representative has signed the informed consent form. Exclusion Criteria: 1. Special Types of Sarcoma: * Gastrointestinal Stromal Tumor (GIST) * Osteosarcoma * Ewing's Sarcoma 2. Prior Treatment History: * Previous radiotherapy to the same site with a cumulative dose that may exceed the normal tissue tolerance dose * Major surgery within 4 weeks 3. Concurrent Diseases: * Active autoimmune diseases * Diseases requiring systemic immunosuppressive therapy * Severe cardiovascular diseases (myocardial infarction, unstable angina, heart failure, etc.) * Severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, etc.) * Active infections requiring systemic anti-infective therapy 4. Central Nervous System Metastasis: Symptomatic brain or spinal metastasis. 5. Pregnancy and Lactation: Women who are pregnant or breastfeeding. 6. Allergy History: Known allergies to the drugs or their components involved in the study.
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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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the First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an oral drug that starves tumors help Hard-to-Treat cancers?
- Can a Dual-Target drug crack resistant gynecologic and breast cancers?
- Can a smart drug hunt down sarcoma cells without harming healthy ones?
- Can a Patient's own immune cells fight advanced sarcoma?
- Smartwatch exercise plan aims to rebuild fitness in young cancer survivors
- Can tailored exercise help young sarcoma survivors recover strength?