NL-OMON53642招募中2 期
CHemotherapy And Sequential ImmunoTherapy for locally advanced urothelial cancer: the CHASIT study - CHASIT
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 58
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Age >= 18 years.
- •2. Have histologically confirmed urothelial carcinoma of the bladder, upper
- •urinary tract or urethra; a maximum of 50% of aberrant histology is allowed.
- •3. Have clinical stage cT4bNxM0 or cTxN1-N3M0 as assessed by bimanual
- •examination under anaesthesia, CT scan, MRI scan or PET-CT scan.
- •4. Have at least stable disease after a minimum of 3 or a maximum of 4 cycles
- •of induction chemotherapy with Cisplatin / Carboplatin + Gemcitabine according
- •to RECIST v1.1.
- •5. Are fit and willing to undergo radical surgery with removal of lymph node
- •template including all affected lymph nodes and the primary tumor.
- •6. World Health Organisation performance status of 0-2.
- •7. Provide written informed consent.
- •8. Negative pregnancy test in women with childbearing potential.
- •9. Adequate bone marrow function, including:
- •a. Absolute neutrophil count (ANC) >=1,500/mm3 or 1.5 x 109/L;
- •b. Platelets >=100 x 109/L;
- •c. Hemoglobin >=5.6 mmol/L (may have been transfused).
- •10. Adequate renal function, defined as estimated creatinine clearance >=30
- •mL/min as calculated by the CKD-EPI eGFR.
- •11. Adequate liver function, including:
- •a. Total serum bilirubin <= 1.5 x upper limit of normal (ULN);
- •b. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5
排除标准
- •1. Predominant (>= 50%) non-urothelial carcinoma histology in the diagnostic
- •endoresection specimen of the bladder, urethra or upper urinary tract. 2. Any
- •test for hepatitis B virus (HBV) or hepatitis C virus (HCV) indicating acute or
- •chronic infection. 3. Have an estimated creatinin clearance as assessed by the
- •CKD-EPI eGFR of < 30 ml/min. 4. Prior exposure to immune-mediated therapy with
- •exclusion of Bacillus-Calmette Gue*rin intravesical instillations, including
- •but not limited to other anti-CTLA-4, anti PD-1, anti PD-L1, or anti-PD-L2
- •antibodies. 5. Persisting toxicity related to prior chemotherapy (Grade >2 NCI
- •CTCAE v5.0). 6. A diagnosis of any other malignancy within 2 years prior to
- •inclusion, except for adequately treated basal cell or squamous cell skin
- •cancer or carcinoma in situ of the breast or of the cervix, low grade prostate
- •cancer on surveillance without any plans for treatment intervention, or
- •prostate cancer that has been adequately treated with prostatectomy or
- •radiotherapy and currently with no evidence of disease. 7. <=2 cycles of
- •induction platinum-based chemotherapy received. 8. Progression of disease
- •during or following induction platinum-based chemotherapy, as assessed by
- •RECIST v1.1. 9. Distant metastatic disease. 10. Previous pelvic radiation
- •therapy. 11. Breastfeeding women. 12. Bilateral upper urinary tract urothelial
- •carcinoma. 13. Active autoimmune disease that might deteriorate when receiving
- •an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis,
- •or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are
- •eligible. 14. Any of the following in the previous 6 months: myocardial
- •infarction, severe/unstable angina, coronary/peripheral artery bypass graft,
- •symptomatic congestive heart failure, cerebrovascular accident, transient
- •ischemic attack, or symptomatic pulmonary embolism. 15. Active infection
- •requiring systemic therapy. 16. Known severe hypersensitivity reactions to
- •monoclonal antibodies (Grade 3), any history of anaphylaxis, or uncontrolled
- •asthma (ie, 3 or more features of asthma symptom control per the Global
- •Initiative for Asthma 2015). 17. Known prior or suspected hypersensitivity to
- •avelumab. 18. Current use of immunosuppressive medication, EXCEPT the
- •following: a. Intranasal, inhaled, topical steroids, or local steroid
- •injections (eg, intra-articular injection); b. Systemic corticosteroids at
- •(equivalent) doses of maximum 10 mg prednisone; c. Steroids as premedication
- •for hypersensitivity reactions (eg, CT scan premedication). 19. Diagnosis of
- •prior immunodeficiency or organ transplant requiring immunosuppressive therapy,
- •or known human immunodeficiency virus (HIV) or acquired immunodeficiency
- •syndrome (AIDS)-related illness. 20. Vaccination within 4 weeks of the first
- •dose of study treatment and while on trial is prohibited except for
- •administration of inactivate vaccines (for example, inactivated influenza
- •vaccines) or mRNA vaccines (for example, COVID-19 vaccines). 21. Other severe
- •acute or chronic medical conditions including colitis, inflammatory bowel
- •disease, and pneumonitis; psychiatric condition including recent (within the
- •past year) or active suicidal ideation or behaviour; or laboratory abnormality
- •that may increase the risk associated with study participation or stud
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