Triple attack on aggressive sarcoma: can radiation, immunotherapy, and chemo shrink tumors before surgery?
NCT ID NCT07817095
First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time
Summary
This phase 2 trial tests a three-part treatment for people with high-risk undifferentiated pleomorphic sarcoma (UPS), a rare cancer of soft tissue. Participants receive focused radiation (SBRT), the immunotherapy drug toripalimab, and a lower dose of the chemotherapy drug liposomal doxorubicin before surgery. After surgery, treatment continues based on how much the tumor responded. Researchers want to see how many tumors show a major pathologic response, meaning most cancer cells are gone, and they track side effects and surgical outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Toripalimab plus liposomal doxorubicin chemotherapy and stereotactic body radiotherapy
- What this could lead to
- If it works, this combination could give people with high-risk UPS better tumor shrinkage before surgery and lower the chance of the cancer returning.
- What could go wrong
- This is a small, single-center phase 2 trial with no comparison group, so any benefit seen may not hold up in larger studies. Combining immunotherapy, radiation, and chemotherapy can also cause serious side effects.
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 39 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 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 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: Inclusion Criteria: 1. Male or female, aged 18 to 75 years. 2. Histologically confirmed UPS, screened locally and confirmed by central pathology before enrollment. Adequate IHC (at least CK, S100, SOX10, SMA, desmin, MDM2, CDK4) and NGS when feasible (MDM2/CDK4 amplification mandatory) to exclude dedifferentiated liposarcoma and other differentiated tumors. 3. UPS of extremities or trunk. Max diameter \>5 cm, or \<=5 cm with any of: encasement of major neurovascular bundle \>180 degrees; expected limb functional loss \>50% after resection; MDT deems R0 difficult. SBRT-feasible anatomy with \>3 mm margin to critical neurovascular structures or joint. 4. Regional nodes evaluated by imaging (US/CT/MRI/PET-CT). Suspicious nodes (short axis \>=10 mm, abnormal morphology, or high FDG) require pathology. Uninvolved nodes must not be irradiated; involved nodes included with radical dose or resected. 5. Treatment-naive: no prior chemotherapy, targeted therapy, immunotherapy, or local radiotherapy. 6. At least one measurable lesion per RECIST v1.1. 7. ECOG 0-1. 8. Adequate organ function. 9. Signed ICF, good compliance, willing to provide fresh tumor and blood for translational research. Exclusion Criteria: 1. Other malignancy, except completed treatment with no recurrence/metastasis within 2 years. 2. Major surgery within 4 weeks, or systemic steroids (\>10 mg/day prednisone equivalent) or immunosuppressants within 2 weeks. 3. Active infection requiring systemic therapy; active HBV (DNA \>=2000 IU/mL), HCV, syphilis, or HIV positive. 4. Active or relapsing autoimmune disease. 5. Severe comorbidity: NYHA \>=III, ischemic heart disease, uncontrolled hypertension/diabetes; interstitial lung disease or severe pulmonary impairment. 6. Known active brain metastases. 7. Pregnancy/breastfeeding, or refusal of effective contraception. 8. Any investigator-judged risk to safety or completion.
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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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Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
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- New cancer drug BBI-355 trial halted early – what we know