Actively Recruiting
The Combination of Radiotherapy, Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma
Led by Fudan University · Updated on 2023-03-17
52
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, single-center, single-arm, phase Ib/II clinical trial. The study aims to evaluate the safety and efficacy of the treatment which combines radiotherapy, chemotherapy and immunotherapy in patients with high-risk localized soft tissue sarcoma. There will be 52 patients with high-risk localized extremity and trunk soft tissue sarcoma recruited. The trail is designed as a two-stage study. In safety lead-in phase (phase Ib), using 3+3 design, 4 cycles of Doxil (37.5 mg/m2, 30 mg/m2, q3w) or doxorubicin hydrochloride (75mg/m2, q3w), Sintilimab (200mg, q3w) and radiotherapy (BED=50-60Gy (α/β=10)) will be applied. In phase II, Doxil will be applied in the recommended phase 2 dose (RP2D) according to phase Ib. And 200mg sintilimab and radiotherapy will be applied as before. The dose-limiting toxicity (DLT) in phase Ib and objective response rate (ORR) in phase Ib+Phase II will be mainly analyzed.
CONDITIONS
Official Title
The Combination of Radiotherapy, Chemotherapy and Immunotherapy in High-Risk Localized Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed soft tissue sarcoma, grade 2 or 3, including pleomorphic undifferentiated sarcoma, liposarcoma, leiomyosarcoma, synovial sarcoma, myxofibrosarcoma, fibrosarcoma, angiosarcoma (excluding radiotherapy-induced angiosarcoma)
- Lesions larger than 5 cm or considered borderline resectable or unresectable by multidisciplinary consultation
- Imaging-confirmed localized lesions on limbs or trunk without distant metastases
- Primary tumor or local recurrence after surgery with disease-free survival over 2 months
- Aged 18 to 70 with ECOG performance status 0-1, or aged 70 to 75 with ECOG 0 and life expectancy over 2 years
- Adequate organ function including bone marrow, liver, and kidney as defined by specific laboratory values
- Willing and able to provide written informed consent for the trial
You will not qualify if you...
- Presence of regional or distant metastases detected by imaging
- Histological types including osteosarcoma, chordoma, classical chondrosarcoma, Kaposi's sarcoma, malignant mesothelioma, and radiation-induced sarcomas
- History of another primary malignant tumor within the past 3 years or concurrent (with some exceptions)
- Chemotherapy within 4 weeks before enrollment, previous anti-PD1 treatment, prior radiotherapy in the radiation field, or contraindications to radiotherapy or surgery
- Uncontrolled high blood sugar or blood clotting disorders
- Active infection requiring systemic treatment
- Major surgery within 2 weeks before enrollment (except minor procedures like biopsy or catheter placement)
- History of immunodeficiency or active autoimmune disease requiring systemic treatment
- Pregnant or breastfeeding females; males planning to father children
AI-Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Y
Yan Wang, M.D, PH.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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