NCT07817095Not yet recruitingPhase 2
SBRT Combined With Reduced-Dose Anthracycline Chemotherapy and Toripalimab as Neoadjuvant Therapy for Localized High-Risk Undifferentiated Pleomorphic Sarcoma
A Single-Arm Phase II Exploratory Study of Neoadjuvant Immunotherapy Plus Chemotherapy Plus SBRT Triplet Therapy and Postoperative Stratified Maintenance Therapy for Undifferentiated Pleomorphic Sarcoma
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
This is a prospective, single-center, single-arm, open-label phase II exploratory study to evaluate the efficacy, safety, and immune remodeling effects of stereotactic body radiotherapy (SBRT) combined with reduced-dose anthracycline chemotherapy and the PD-1 inhibitor toripalimab as neoadjuvant therapy, followed by postoperative stratified maintenance therapy, in patients with localized high-risk undifferentiated pleomorphic sarcoma (UPS). A Simon two-stage design will be used, with 39 patients planned (stage 1: 13 patients; 35 patients in total, including a 10% dropout rate). Treatment consists of SBRT (8-10 Gy in 5 fractions) followed by toripalimab (240 mg intravenously every 3 weeks, 3 cycles in the neoadjuvant phase) combined with liposomal doxorubicin (30-40 mg/m² intravenously every 3 weeks, 2 cycles in the neoadjuvant phase). After response evaluation, radical surgery is performed. Postoperative stratified maintenance therapy is delivered according to pathological response: patients achieving major pathologic response (MPR) or hyalinized pathologic response (HPR) receive toripalimab monotherapy (240 mg every 3 weeks, up to 14 cycles), while those not achieving MPR/HPR receive toripalimab combined with liposomal doxorubicin (2-4 cycles). The primary endpoint is the rate of major pathologic response (MPR). Secondary endpoints include the rate of hyalinized pathologic response (HPR), radiologic objective response rate (ORR), R0 resection rate, limb salvage rate, and safety.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 39 (estimated)
- First submitted
- 8 Sept 2026
- Start date
- Sept 2026
- Primary completion date
- Jan 2029
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Sarcoma
- NCT number
- NCT07817095
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 39
- From Sept 2026 to the primary completion date, Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other malignancy, except completed treatment with no recurrence/metastasis within 2 years.
- Major surgery within 4 weeks, or systemic steroids (\>10 mg/day prednisone equivalent) or immunosuppressants within 2 weeks.
Other illness
- Active infection requiring systemic therapy; active HBV (DNA \>=2000 IU/mL), HCV, syphilis, or HIV positive.
- Active or relapsing autoimmune disease.
- Severe comorbidity: NYHA \>=III, ischemic heart disease, uncontrolled hypertension/diabetes; interstitial lung disease or severe pulmonary impairment.
Other
- Known active brain metastases.
- Pregnancy/breastfeeding, or refusal of effective contraception.
- Any investigator-judged risk to safety or completion.
Who the study is looking for
- Male or female, aged 18 to 75 years.
- 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.
- 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.
- 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.
- Treatment-naive: no prior chemotherapy, targeted therapy, immunotherapy, or local radiotherapy.
- At least one measurable lesion per RECIST v1.1.
- ECOG 0-1.
- Adequate organ function.
- Signed ICF, good compliance, willing to provide fresh tumor and blood for translational research.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.