KCT0006077尚未招募未知
An open-label multi-center phase 2 study of Genexol-PM and atezolizumab in patients with locally advanced and metastatic urothelial carcinoma who have progressed following treatment with platinum-based chemotherapy
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 97
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 0No Limit（—）
- 性别
- All
入选标准
- •1) Patients with pathologic confirmed locally advanced and/or metastatic urotheilal cancer
- •2) Failure of previous platinum-based chemotherapy due to disease progression or intolerance
- •3) Available infomred conset with sign for study participation
- •4) The ability to comply with the clinical trial plan
- •5) 19 years old or older
- •6) ECOG performance status 0 or 1
- •7) Measurable diseases based on RECIST v1.1 (including at least one target lesion)
- •8) Proper hematologic function and peripheral organ function defined as the results of laboratory tests collected within 14 days before the commencement of the drug administration
- •9) Negative for HIV, HBV, and HCV infection of activity
- •10) In the case of fertile women: agree to maintain abstinence (no sexual intercourse between sexes), agree to use contraception, and refrain from ovum donation
- •12) In the case of men: maintain abstinence (no sexual intercourse), agree to use birth control and refrain from sperm donation
- •·Available tumor tissue exists and is willing to provide
排除标准
- •1) Previous use of immune checkpoint co-stimulators or checkpoint inhibitors including anti-CTLA-4, anti-PD-1, anti-PD-L1 antibodies
- •2) Previously using Genexol PM or paclitaxel
- •3) Radiotherapy of bone metastasis or soft tissue lesions should be completed 14 days prior to base line imaging.
- •4) Hormone replacement therapy or oral contraception
- •5) Former hematopoietic stem cells or solid organs transplant
- •6) Systemic immunosuppressants are expected to be required during the treatment or administration of systemic immunosuppressants (when used more than 10mg / day as Prenisolone or equivalent doses, including cyclophosphamide, azatioprine, methotrexate, thalidomide, and anti-cancer immunosuppressants) within two weeks prior to the commencement of the medication.
- •7) Uncontrolled pleural effusion, pericardial effusion, and peritoneal effusion that require repetitive drainage
- •8) Uncontrolled hypercalcemia
- •9) Uncontrolled brain metastasis
- •10) Previous history of leptomeningeal disease
- •11) Previous history of active autoimmune disease or immunodeficiency
- •12) Active interstitial pneumonitis
- •13) History of cancer other than urothelial carcinoma within two years before screening
- •14) Active tuberculosis
- •15) Severe infection within 14 days prior to the commencement of test medication, including hospitalization, bacteremia or severe pneumonia due to infection complications
- •16) Treatment of oral or administered antibiotics within seven days before the commencement of the trial
- •17) Significant cardiovascular diseases such as New York Heart Association (New York Heart Association) heart disease (grade III or higher), myocardial infarction or cerebrovascular accident, unstable arrhythmia or unstable angina
- •18) Uncontrolled hypertension
- •19) Bleeding more than grade 3 within 14 days before treatment start
- •20) A large surgical procedure is expected to be required during treatment or within 14 days before treatment start, not for diagnostic goal
- •21) Adverse events caused by previous chemotherapy that have not improved below grade 1, except for all grades of hair loss and peripheral neuropathy under grade 2
- •22) Other diseases, metabolic dysfunction, physical examination findings or clinical laboratory findings that may be considered taboo, affect the interpretation of the results, impair the patient's ability to participate in the test, or put the patient at high risk of administration complications
- •23) A history of severe allergies to chimera or humanized antibodies or fused proteins
- •24) Known irritability of Chinese hamster ovarian cell preparation or recombinant human antibodies
- •25) Known intolerance to all test drugs or their siblings
- •26) Known intolerance to all drugs needed for premedication
研究者
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