Actively Recruiting
The Combination of Radiotherapy，Surufatinib and Sintilimab in High-Risk Localized Soft Tissue Sarcoma
Led by Fudan University · Updated on 2023-08-21
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, Sintilimab (Anti-PD1 Antibody) and Surufatinib (small-molecule Tyrosine Kinase inhibitor) in patients with high-risk localized soft tissue sarcoma. There will be 52 patients with high-risk localized extremity and trunck soft tissue sarcoma recruited. The trail is designed as a two-stage study. In safety lead-in phase (phase Ib), using 3+3 design, 6 cycles of Surufatinib (250mg, 200mg, qd) and Sintilimab (200mg, q3w) will be applied. And radiotherapy (BED=50-60Gy (α/β=10)) will begin in week 4 of the therapy. In extended phase (phase II), Surufatinib 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，Surufatinib and Sintilimab in High-Risk Localized Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged from 18 to 70 years with a life expectancy of more than 2 years
- Histologically confirmed soft tissue sarcoma, grade 2 or 3
- Imaging-confirmed localized lesions on limbs or trunk without distant metastases
- Lesion size greater than 5 cm or lesions assessed as borderline resectable or unresectable after multidisciplinary consultation
- Local recurrence after surgery with disease-free survival of more than 2 months, or primary tumor
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function (bone marrow, liver, kidney, clotting) within 7 days before first treatment without blood products or growth factors
- Fully informed and willing to provide written informed consent
You will not qualify if you...
- Regional or distant metastases detected by imaging
- Histological types: osteosarcoma, chordoma, classic chondrosarcoma, Kaposi's sarcoma, malignant mesothelioma, radiation-induced sarcomas
- History of another primary malignant tumor within the past 3 years or concurrent (except certain localized skin and cervical cancers or tumors with >10 years disease-free survival)
- Received chemotherapy or targeted therapy within 4 weeks before enrollment
- Prior anti-PD1 immunotherapy
- Prior radiotherapy to target lesion or contraindications to radiotherapy or surgery
- Abnormal baseline laboratory values: neutrophils <1.5x10^9/L, hemoglobin <90g/L, platelets <100x10^9/L, ALT or AST >2.5 times upper limit of normal, creatinine >1.5 times upper limit of normal or creatinine clearance <50ml/min, total bilirubin >1.5 times upper limit of normal, APTT or PT >1.5 times upper limit of normal
- Urinary protein ≥2+ or 24-hour urine protein ≥1.0g
- Uncontrolled hypertension (systolic >140 mmHg or diastolic >90 mmHg)
- Uncontrolled high blood sugar or blood clotting disorders
- Active infection needing systemic anti-infective treatment
- Uncontrolled mental illness
- Surgery within 2 weeks before enrollment (except biopsy or catheter implantation)
- History of immunodeficiency or active autoimmune disease requiring systemic treatment
- Pregnant or breastfeeding women
- Allergy to any component of the study treatment
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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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