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New combo therapy aims to tackle tough sarcomas

NCT ID NCT07342322

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • 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.