KCT0003804
Completed
未知
A Prospective Study of Neoadjuvant Chemotherapy with Nivolumab/Gemcitabine/Platinum in Muscle-Invasive or Locally-Advanced Urothelial Carcinoma of Bladder
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Center
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Subject is at least 20 years of age.
- •2\.Subject has a histologically or cytologically confirmed diagnosis of urothelial carcinoma arising from urinary bladder.
- •3\.Muscle\-invasive, high\-risk (T3 or T4a) disease with no other treatment options than radical cystectomy.
- •4\.Subject has an ECOG performance status of 0 to 1\.
- •5\.Subject has a life expectancy of 6 months or more.
- •6\.At least 2 weeks since the last surgical procedures or biopsies prior to enrolment. Subjects must have recovered to 7\.Acceptable liver function:
- •a.Bilirubin ? 1\.5 times upper limit of normal (x ULN); does not apply to subjects with Gilbert’s syndrome diagnosed as per institutional guidelines.
- •b.AST (SGOT) and ALT (SGPT) ? 3 x ULN
- •8\.Acceptable renal function with serum creatinine ? 1\.5 x ULN or a calculated creatinine clearance \= 60 mL/min using the Cockcroft\-Gault or MDRD formulas.
- •9\.Acceptable hematologic status (without growth factor support or transfusion dependency):
Exclusion Criteria
- •1\.Ongoing treatment with an anticancer agent not contemplated in this protocol.
- •2\.Radiologic finding consistent with extravesical and/or metastatic disease.
- •3\.Severe medical or phychological illness that preclude participation to study, including any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
- •4\.Non\-tolerable \> Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1\.
- •5\.Major surgery, other than diagnostic surgery or transurethral resection, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
- •– Patients who have received systemic corticosteroids (except for temporary use, e.g., for examination or prophylaxis of allergic reactions) or immunosuppressants within 28 days before randomization
- •– Patients who have received antineoplastic drugs (e.g., chemotherapy agents, molecular\-targeted therapy agents, or immunotherapy agents) within 28 days before randomization
- •– Patients who have undergone surgical adhesion of the pleura or pericardium within 28 days before randomization
- •– Patients who have undergone surgery involving local or topical anesthesia within 14 days before Randomization
- •– Patients who have received radiotherapy within 28days before randomization, or radiotherapy to bone metastases within 14 days before randomization
Outcomes
Primary Outcomes
Not specified
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