Triple attack on aggressive sarcoma: can radiation, immunotherapy, and chemo shrink tumors before surgery?

NCT ID NCT07817095

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

Phase 2

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

Participants

About 39 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2030

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: 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.

  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

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Contacts and locations

Locations

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, China

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