Phase
Condition
N/ATreatment
Stereotactic Body Radiation Therapy (SBRT)
TORIPALIMAB INJECTION(JS001 )
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-75 years old, gender is not limited;
Histologically or pathologically confirmed non-specific invasive ductal carcinoma,histologically grade3, ER≥1%, HER2 negative, Ki-67>20%;
T1c-T2(≥2cm)N1-2M0 or T3-4cN0-2M0;
No previous treatment;
ECOG PS 0-1 score;
The subject or legal representative has been informed of the nature of the study,understands the protocol, is able to guarantee compliance, and signs the informedconsent
Exclusion
Exclusion Criteria:
Those who are known to be allergic to recombinant humanized antiPD-1 monoclonalantibody drugs and their components;
Currently participating in and receiving other research treatment;
Previously received systematic treatment for breast cancer, including systematicchemotherapy, targeted therapy, immunotherapy, etc.;
Remote metastatic lesions of breast cancer were confirmed by imaging or pathology;
Patients with active tuberculosis (TB) who are receiving anti-TB therapy or havereceived anti-TB therapy within 1 year prior to screening;
Uncontrolled or symptomatic hypercalcemia (> 1.5mmol/L calcium ion or calcium > 12mg/dL or corrected serum > ULN);
Clinically uncontrolled active infections, including but not limited to acutepneumonia;
Uncontrollable major seizures or superior vena cava syndrome;
previous or current co-occurrence of other malignant tumors (except for non-melanomaskin basal cell carcinoma or squamous cell carcinoma, breast/cervical carcinoma insitu, superficial bladder carcinoma and other in situ cancers that have been treatedradically and have no evidence of disease recurrence);
Have a history of interstitial pneumonia, idiopathic pulmonary fibrosis,institutional pneumonia (such as bronchiolitis obliterans), drug-induced pneumonia,idiopathic pneumonia, chest CT screening found evidence of active pneumonia or othermoderate to severe lung diseases that seriously affect lung function;
Known human immunodeficiency virus (HIV) infection (known HIV antibody positive);
Severe cardiovascular disease, such as New York Heart Association (NYHA) grade 2 orhigher heart failure, unstable angina, unstable arrhythmia, myocardial infarction orcerebrovascular accident within the first 6 months of enrollment;
received systemic immunosuppressive drugs (i.e. use of corticosteroids orimmunosuppressive drugs) for any active autoimmune disease within 2 years prior tostudy initiation;
Received live virus vaccine within 4 weeks prior to study initiation;
Patients who have previously received allogeneic stem cells or parenchymal organtransplants;
Pregnant or lactating women or women who have the possibility of becoming pregnanthave tested positive for pregnancy before the first drug use, and patients who arefertile but do not want to take contraceptive measures or their sexual partners donot want to take contraceptive measures
Any other clinically significant illness or condition that the investigator believescould affect adherence to the protocol (such as a history of mental illness orsubstance abuse), prevent the patient from benefiting from the clinical study, orprevent the patient from signing informed consent (such as drug use and substanceabuse), or make participation in the clinical study inappropriate (including but notlimited to: Abnormal laboratory results, clinical active diverticulitis, abdominalabscess, intestinal obstruction, and peritoneal metastases).
Study Design
Study Description
Connect with a study center
the First Affiliated Hospital,Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.