RE: SCIB1 Clinical Trial28 Jul 2020 10:01
this was the original criteria of Scib1 adjuvant
Exclusion Criteria:
Known brain metastases at screening.
Life expectancy of less than three months.
Patients with TNM classification M1c at screening.
Prior systemic anti-cancer treatment within four weeks of screening.
Prior treatment with systemic corticosteroids or other immunosuppressants within four weeks of screening.
Previous (within five years) or current malignancy at other sites with the exception of curatively treated local tumours such as carcinoma-in-situ of the cervix, basal or squamous cell carcinoma of the skin.
Pregnant or lactating women.
Presence of any uncontrolled and significant medical or psychiatric condition which would interfere with trial safety assessments. Caution should be used for patients with suspected or diagnosed epilepsy.
Any electronic stimulation device such as cardiac demand pacemaker, automatic implantable cardiac defibrillator, nerve stimulators or deep brain stimulators.
Individuals in which a skin-fold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid or quadriceps muscles with intact lymph drainage) exceeds 40 mm.
Individuals with a heart rate of = 50 beats per minute, history of significant cardiac abnormality and/or significant abnormal baseline electrocardiogram (ECG) readout.
Treatment with any investigational product within the four weeks preceding screening.
v
Exclusion Criteria:
Active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 years prior to the first dose of trial treatment.
Major surgical procedure within 28 days prior to enrollment. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
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