EUCTR2017-003185-27-FR进行中（未招募）1 期
A non-comparative randomized 2:1 phase II study of docetaxel, cisplatin, and 5-fluorouracil in combination or not with atezolizumab in patients with metastatic or unresectable locally advanced squamous cell anal carcinoma
GERCOR0 个研究点目标入组 99 人开始时间: 2018年2月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 99
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female, aged =18 years,
- •2. Performance status Eastern Cooperative Oncology Group World Health Organization (ECOG-WHO) =1,
- •3. Histologically proven and unresectable locally advanced recurrent or metastatic squamous cell anal carcinoma,
- •4. Presence of a target lesion on CT-scan assessed by RECIST v1.1 criteria,
- •5. Patient eligible to the mDCF regimen,
- •6. CT scan performed within 28 days prior inclusion,
- •7. PET scan performed within 28 days prior inclusion,
- •8. Signed and dated informed consent,
- •9. Patient affiliated to or beneficiary of French social security system,
- •10. Ability to comply with the study protocol, in the Investigator’s judgment,
- •11. Life expectancy >=6 months,
- •12. Adequate hematologic and end-organ function.
- •NB: Previous concomitant chemoradiotherapy is allowed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •1. Previously received chemotherapy for metastatic disease,
- •2. Previously received cisplatin except for concomitant chemoradiotherapy,
- •3. Previously received taxanes (paclitaxel or docetaxel) or another spindle poison (navelbine) in the treatment of SCCA,
- •4. Previously received anti-tumor immunotherapy (HPV vaccination is allowed),
- •5. Diagnosis of additional malignancy within 3 years prior to the randomization with the exception for curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer,
- •6. Any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study,
- •7. Current participation in a study of an investigational agent or in the period of exclusion,
- •8. Pregnancy, breast-feeding or absence/refusal of adequate contraception for fertile patients during the period of treatment and for 6 months from the last treatment administration,
- •9. Patient under guardianship, curatorship or under the protection of justice.
- •10. Inadequate organ functions: uncontrolled cardiac condition, known cardiac failure, unstable coronaropathy, respiratory failure, and Chronic Obstructive Pulmonary Disease (COPD),
- •11. Diabetes with vascular or neurovascular complications,
- •12. Preexistent peripheral neuropathy or impaired audition,
- •13. HIV positive with CD4 count under 400 cells/mm3 (VIH test is mandatory before inclusion),
- •14. Active hepatitis B or C virus (HBV or HCV) infection (chronic or acute), (Defined as having a positive HBV surface antigen (HBsAg) test at screening. Patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total HBV core antibody (HBcAb) test at screening, are eligible for the study.
- •15. Active tuberculosis,
- •16. Concomitant treatment with CYP3A4 inhibitor like ritonavir, indinavir, or ketoconazole, etc. Replacement by another drug before randomization, whenever is possible, is allowed,
- •17. Known hypersensitivity or contraindication to any of the study chemotherapy drugs (taxanes, cisplatin, 5FU),
- •18. Uncontrolled infection or another life-risk condition,
- •19. Known hearing impairment that contraindicates cisplatin administration,
- •20. Administration of a live (attenuated) vaccine within 28 days of planned start of study therapy of known need for this vaccine during treatment,
- •21. Administration of prophylactic phenytoin,
- •22. Inadequate laboratory values: creatinine clearance <60 ml/min, neutrophil count <1500 /mm3, platelets <100000/mm3, bilirubin 2.5 x upper limit of normal (ULN), aspartate transaminase (AST)/alanine transaminase (ALT) 2.5 x ULN or 5 x ULN with liver metastasis.
- •Non-eligible to immunotherapy:
- •23. Any immunosuppressive therapy (i.e. corticosteroids >10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy,
- •24. Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed.
- •Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, (see Annex 7 for a more comprehensive list of autoimmune diseases and im
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