KCT0005761招募中未知
Phase III Double-Blind Randomized Placebo Controlled Trial of Atezolizumab in Combination with Paclitaxel and Carboplatin in Women with Advanced/Recurrent Endometrial Cancer (AtTEnd – Atezolizumab Trial in Endometrial cancer)
CHA University Ilsan Medical Center0 个研究点目标入组 550 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 550
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 o Limit（—）
- 性别
- Female
入选标准
- •I-1. Newly diagnosed, histologically-confirmed with residual disease after surgery either measurable or evaluable, or inoperable stage III-IV endometrial carcinoma/carcinosarcoma, after diagnostic biopsy, and naïve to first line systemic anti-cancer treatment. Recurrent endometrial cancer patients if not yet treated with a chemotherapy line for recurrent disease. Hormonal treatment (including but not limited to progestins, tamoxifen, luteinizing hormone-releasing hormone agonists, aromatase inhibitors) without chemotherapy is allowed.
- •I-2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •I-3. Age = 18 years
- •I-4. Only one prior line of systemic platinum-based regimen is permitted if the platinum-free interval = 6 months. Such prior line is the up-front/adjuvant treatment which can be concurrent chemoradiation or concurrent chemoradiation followed by chemotherapy or only chemotherapy.
- •I-5. Patients with history of primary breast cancer may be eligible provided they completed their definitive anticancer treatment more than 3 years ago and they remain breast cancer disease free prior to start of study treatment.
- •I-6. Previous pelvic and outside pelvis radiation is allowed if completed more than 6 weeks ago.
- •I-7. Signed informed consent and ability to comply with treatment and follow-up.
- •Representative FFPE tumor sample or, only if unfeasible, at least 20 unstained slides from initial surgery or from diagnostic biopsy, in case surgery was not performed, available and sent to central laboratory for Micro Satellite (MS) determination prior to randomization.
- •I-8. Patients must have normal organ and bone marrow function :
- •a. Haemoglobin = 10.0 g/dL.
- •b. Absolute neutrophil count (ANC) = 1.5 x 109/L.
- •c. Platelet count = 100 x 109/L.
- •d. Total bilirubin = 1.5 x institutional upper limit of normal (ULN).
- •e. Aspartate aminotransferase /Serum Glutamic Oxaloacetic Transaminase (ASAT/SGOT)) and Alanine aminotransferase /Serum Glutamic Pyruvate Transaminase (ALAT/SGPT)) = 2.5 x ULN, unless liver metastases are present in which case they must be = 5 x ULN.
- •f. Serum creatinine = 1.5 x institutional
排除标准
- •E-1. Other malignancy within the last 5 years except: adequately treated non-melanoma
- •skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast. Patients with a history of localized malignancy diagnosed over 5 years ago may be eligible provided they completed their adjuvant systemic therapy prior to randomization and that the patient remains free of recurrent or metastatic disease.
- •E-2. Patients with uterine leiomyosarcoma .
- •E-3. Major surgery within 4 weeks of starting study treatment or patients who have not completely recovered from the effects of any major surgery.
- •E-4. Previous allogeneic bone marrow transplant or previous solid organ transplantation.
- •E-5. Administration of other simultaneous chemotherapy drugs, any other anticancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy is permitted).
- •E-6. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA4 .
- •E-7. Treatment with systemic immunostimulatory agents (including but not limited to
- •interferon-alpha (IFN-a) and interleukin-2 (IL-2) within 4 weeks or five half-lives of the drug (whichever is shorter) prior to Cycle 1, Day 1.
- •E-8. Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to Cycle 1, Day 1, or anticipated requirement for systemic immunosuppressive medications during the trial. However, please note that the use of inhaled corticosteroids for chronic obstructive pulmonary disease or for asthma is allowed, as well as the use of mineralocorticoids (e.g., fludrocortisones) and low-dose supplemental corticosteroids for adrenocortical insufficiency and for patients with orthostatic hypotension. The use of corticosteroids as premedication for paclitaxel-based regimen is allowed).etc
研究者
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