Combining radiotherapy, chemotherapy, and immunotherapy for high-risk localized soft tissue sarcoma
A Prospective Phase Ib/II Trial of Preoperative Radiotherapy Combined With Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma
This study is testing a new treatment that combines radiation, chemotherapy, and immunotherapy to see if it helps people with high-risk localized soft tissue sarcoma.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation, Sintilimab, immunotherapy, doxorubicin |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05774275 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a treatment regimen that combines radiotherapy, chemotherapy, and immunotherapy in patients with high-risk localized soft tissue sarcoma. It is a single-center, single-arm study designed in two phases: a safety lead-in phase (Phase Ib) followed by a Phase II evaluation. A total of 52 patients with specific types of sarcoma will receive a combination of Doxil or doxorubicin, Sintilimab, and radiotherapy. The study will analyze dose-limiting toxicity and objective response rates to determine the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 75 with histologically confirmed high-risk localized soft tissue sarcoma and specific tumor characteristics.
Not a fit: Patients with distant metastases or those with radiotherapy-induced angiosarcoma may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve outcomes for patients with high-risk localized soft tissue sarcoma.
How similar studies have performed: While this approach combines established treatments, the specific combination and methodology are novel and have not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically confirmed STS, G2 or G3. The histological types include: pleomorphic undifferentiated sarcoma, liposarcoma, leiomyosarcoma, synovial sarcoma, myxofibrosarcoma, fibrosarcoma, angiosarcoma but not radiotherapy-induced angiosarcoma, etc. 2. Has\>5 cm lesions, or the lesions are determined to be borderline resectable or unresectable by a multidisciplinary consultation. 3. Has imaging-confirmed localized lesions on the limbs or trunk without distant metastases. 4. Experience primary tumor or local recurrence after surgery (disease-free survival more than 2 months after surgery) 5. Aged from 18 to 70, with ECOG performance status 0-1, or aged from 70 to 75, with ECOG performance status 0. Has life expectancy more than 2 years 6. Demonstrate adequate organ function (bone marrow, liver, and kidney function) (Leukocytes ≥ 3 × 10\^9 /L, Neutrophils ≥ 1.5 × 10\^9 /L, Hemoglobin ≥ 90 g/L, Platelet count ≥ 100 × 10\^9 /L, Total bilirubin ≤1.5 × institutional upper limit of normal (ULN), Aspartate transaminase ≤2.5 × ULN, Alanine transaminase ≤2.5 × ULN, Serum creatinine ≤1.5 × ULN or creatinine clearance ≥60 mL/min.) 7. Fully informed and willing to provide written informed consent for the trial. Exclusion Criteria: 1. The presences of regional or distant metastases detected by imaging evaluation 2. Patients with the following histological types: osteosarcoma, chordoma, classical chondrosarcoma, Kaposi's sarcoma, malignant mesothelioma, radiation-induced sarcomas. 3. Known history of another primary malignant tumor within the past three years or at the same time (excluding localized basal cell carcinoma, cutaneous squamous cell carcinoma, ductal carcinoma in situ, lobular carcinoma in situ, adenocarcinoma in situ of cervix, or other previous malignant tumor with a disease-free survival of more than five years) 4. Known history of other chemotherapy within 4 weeks before enrolment, previous anti-PD1 treatment, previous radiotherapy in the radiation field, or has other contraindications to radiotherapy or surgery. 5. Uncontrolled hyperglycaemia or Coagulation disorder 6. Active infection requiring systemic anti-infective therapy 7. Previous major surgery within 2 weeks before enrolment (excluding minor operation such as diagnostic biopsy or peripherally inserted central catheter implantation) 8. Known history of immunodeficiency diseases or active autoimmune disease requiring systemic treatment 9. Female patients pregnant or breastfeeding, Male patients expecting to have babies
Where this trial is running
Shanghai, Shanghai Municipality
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Principal investigator: Zhen Zhang, M.D, PH.D — Fudan University
- Study coordinator: Yan Wang, M.D, PH.D
- Email: wangxyyan@sina.com
- Phone: 18121299388
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.