Geno-radiomics Based Model for Response and Prognostic Evaluation of Immunotherapy and Targeted Therapy for Advanced Soft Tissue Sarcoma

Peking Union Medical College Hospital1 site in 1 country60 target enrollmentFebruary 2, 2023

ConditionsAdvanced Soft Tissue Sarcoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Advanced Soft Tissue Sarcoma
Sponsor: Peking Union Medical College Hospital
Enrollment: 60
Locations: 1
Primary Endpoint: The accuracy of Geno-radiomics-based model for response evaluation of immunotherapy and targeted therapy for advanced soft tissue sarcoma
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2, 2023

End Date

February 2, 2027

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects aged from 18 to 75 years old;
•Subjects with histologically confirmed unresectable locally advanced or metastatic soft tissue sarcoma, which includes synoviosarcoma, leiomyosarcoma, undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma, fibrosarcoma, epithelioid sarcoma, angiosarcoma, alveolar soft-part sarcoma, etc. Chondrosarcoma, osteosarcoma, dermatofibrosarcoma protuberans, gastrointestinal stromal tumor and malignant mesothelioma are excluded;
•Patients who agree to receive small molecule multi-target TKI and anti-PD-1 or anti-PD-L1 monoclonal antibody therapy, without contraindications in the use of related drugs;
•Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Previously irradiated focus can be considered as measurable only if there is definite progress after radiotherapy;
•Newly obtained or archived tumor tissue samples can be provided;
•Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 at trial entry;
•Estimated life expectancy of more than 12 weeks;
•Adequate organ functions defined by the protocol;
•Negative blood pregnancy test at Screening for women of childbearing potential within 1 week before the first medication; Highly effective contraception for both male and female subjects if the risk of conception exists; Able to comply with the research protocol and follow-up process for treatment and follow-up;
•Already signed an informed consent form.

Exclusion Criteria

•Patients whose tumors are judged by the investigators to be at high risk of invading vital blood vessels and causing fatal hemorrhage during the study.
•Occurrence of arterial/venous thrombotic events within 6 months before treatment, such as cerebrovascular accident (including transient ischemic attack, hematencephalon and cerebral infarction), deep vein thrombosis , pulmonary embolism, etc.
•Occurrence of clinically significant hemoptysis(\>5ml fresh blood in 4 weeks), hemorrhagic tendency(bleeding\>30ml within 3 months), such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood test(FOBT) ++ in the baseline period , or vasculitis, etc;
•Hypertension that cannot be controlled stably by drugs, which is defined as: systolic blood pressure\>140mmHg or diastolic blood pressure\>90mmHg;
•With clinically significant cardiovascular diseases, including but not limited to: acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; congestive heart failure with New York Heart Association (NYHA) grade≥2; cardiac revascularization, hemodynamic unstable arrhythmia; Left ventricular ejection fraction(LVEF) \<50%;
•QTc interval ≥ 480 milliseconds (ms) on electrocardiogram (ECG);
•24-h urinary protein level \>1.0g/day;
•Serum potassium, calcium (after correction for ionic or albumin-bound type) or magnesium are beyond the normal range and have clinical significance.
•Abnormal coagulation function (INR\>1.5 or PT\>ULN+4s or APTT \>1.5 ULN), hemorrhagic tendency or being treated with thrombolysis or anticoagulation therapy. Notes: on the premise of INR ≤ 1.5, it is allowed to use low-dose heparin (daily dosage of adults is 6000-12000U) or low-dose aspirin (daily dosage ≤ 100mg) for preventive purposes;
•With factors affecting oral drug administration: dysphagia, post-gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc

Outcomes

Primary Outcomes

The accuracy of Geno-radiomics-based model for response evaluation of immunotherapy and targeted therapy for advanced soft tissue sarcoma

Time Frame: From the start of randomization to a minimum of 42 months

Receiver operating characteristic (ROC) curves and area under the curve (AUC) are used to evaluate the accuracy of the model

Secondary Outcomes

The accuracy of Geno-radiomics-based model for predicting prognosis of immunotherapy and targeted therapy for advanced soft tissue sarcoma(From the start of randomization to a minimum of 42 months)