Actively Recruiting
Geno-radiomics Based Model for Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma
Led by Peking Union Medical College Hospital · Updated on 2023-10-02
60
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
In this study, a new post-processing image technology - radiomics is used to screen out parameters of CT and MRI images, which could effectively evaluate the efficacy and prognosis of immunotherapy plus targeted therapy for soft tissue sarcoma (STS). A reliable and effective model for predicting the prognosis of STS will be established based on the radiomic parameters combined with traditional imaging, histophiological, whole exome sequencing (WES) results, inflammatory indicators and changes in the number and function of lymphocyte subsets before and after medication. Patients with advanced STS who may benefit from the combination therapy can be found out by this model.
CONDITIONS
Official Title
Geno-radiomics Based Model for Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged from 18 to 75 years old
- Histologically confirmed unresectable locally advanced or metastatic soft tissue sarcoma, including synoviosarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, fibrosarcoma, epithelioid sarcoma, angiosarcoma, alveolar soft-part sarcoma
- Agreement to receive small molecule multi-target TKI and anti-PD-1 or anti-PD-L1 monoclonal antibody therapy without contraindications
- Disease measurable by RECIST 1.1 criteria; previously irradiated focus considered measurable if progressed after radiotherapy
- Ability to provide newly obtained or archived tumor tissue samples
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at entry
- Estimated life expectancy of more than 12 weeks
- Adequate organ functions as defined by the protocol
- Negative blood pregnancy test within 1 week before first medication for women of childbearing potential
- Use of highly effective contraception if risk of conception exists
- Ability to comply with study protocol and follow-up
- Signed informed consent form
You will not qualify if you...
- Tumors judged at high risk of invading vital blood vessels causing fatal hemorrhage
- Arterial or venous thrombotic events within 6 months before treatment
- Clinically significant hemoptysis (>5ml fresh blood in 4 weeks) or hemorrhagic tendency (>30ml bleeding in 3 months)
- Uncontrolled hypertension (systolic >140mmHg or diastolic >90mmHg)
- Significant cardiovascular diseases including recent myocardial infarction, severe angina, congestive heart failure (NYHA grade ≥2), unstable arrhythmia, LVEF <50%
- QTc interval ≥480 ms on ECG
- 24-hour urinary protein level >1.0g/day
- Abnormal serum potassium, calcium, or magnesium with clinical significance
- Abnormal coagulation function or current anticoagulation therapy beyond allowed low-dose preventive use
- Conditions affecting oral drug administration such as dysphagia or intestinal obstruction
- Active central nervous system metastasis or cancerous meningitis
- Active autoimmune disease requiring systemic immunosuppressants
- Systemic steroid or immunosuppressive treatment within 3 days before first dose (with some exceptions)
- Active infections including HIV or active tuberculosis
- Chronic hepatitis B with HBV DNA ≥100 IU/mL without antiviral treatment
- Previous malignancy within 5 years except certain skin or cervical cancers
- Anticancer treatment within 4 weeks before study
- Prior use of anti-angiogenic or anti-PD-1/PD-L1/PD-L2 drugs or other immune checkpoint drugs
- Allergy to components of surufatinib or envafolimab
- Vaccination with live or attenuated viruses within 4 weeks before or during study
- Major surgery, severe trauma, fracture, or ulcer within 4 weeks before treatment
- Pregnant or lactating women
- Participation in other clinical trials within 4 weeks before enrollment
- Other severe diseases, mental disorders, laboratory abnormalities, or social factors that may affect study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
X
Xiang Wang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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