ACTRN12621000273886招募中2 期
The effect of adjuvant tislelizumab plus chemotherapy on failure free survival after post-operative pelvic chemoradiation in high risk endometrial cancer - ADELE: a randomised phase 2 trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 135
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Female
入选标准
- •INCLUSION CRITERIA AT REGISTRATION:
- •1) People aged 18 years and older, with a histological diagnosis of high-risk endometrial cancer where adjuvant chemotherapy is indicated. High-risk is defined as follows. Note: ECs with mixed histology will be accepted.
- •a) As per FIGO 2023: stage II-IVA endometrial cancer
- •b) As per FIGO 2018:
- •i) stage IA (with myometrial invasion) - IVA endometrial cancer with serous, clear cell, carcinosarcoma or mixed histology; or
- •ii) stage III or IVA endometrial cancer with endometroid histology, any grade; or
- •iii) Stage II endometrial cancer with endometroid histology, that is grade 3 or p53 abnormal by IHC or mutation testing
- •2) Completed prior surgical treatment with total hysterectomy and bilateral salpingo-oophorectomy +/- lymph node evaluation (either lymph node sampling or lymphadenectomy) and planned for adjuvant therapy
- •3) Have not received any prior chemotherapy for endometrial cancer (adjuvant pelvic chemoradiation exempted)
- •4) Have not received any prior pelvic radiation therapy (adjuvant pelvic chemoradiation exempted)
- •5) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (Appendix 3)
- •6) Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- •7) Signed, written informed consent
- •INCLUSION CRITERIA AT RANDOMISATION:
- •8) Participants with AEs as a result of pelvic chemoradiation must have recovered to baseline or at least Grade 1 as per CTCAE v5.0. Note: participants with the following AEs that are not considered a safety risk by investigator are exempted and may proceed to randomisation: alopecia or isolated laboratory abnormalities that are not clinically significant.
- •9) Adequate bone marrow function
- •Haemoglobin greater or equal to 90 g/L
- •Absolute neutrophil count greater or equal to 1.5 x 10^9/L
- •Platelets greater or equal to 100 x 10^9/L
- •10) Adequate liver function
- •Alanine transaminase lesser or equal to 2.5 x upper limit of normal (ULN)
- •Aspartate aminotransferase lesser or equal to 2.5 x ULN
- •Total bilirubin lesser or equal to 1.5 x ULN (except participants with Gilbert’s
- •syndrome, who are eligible with bilirubin lesser or equal to 3 ULN)
- •11) Adequate renal function
- •creatinine clearance greater or equal to 50 ml/min as per Cockcroft-Gault Equation
- •greater or equal to 50 mL/min as per measured renal nuclear glomerular filtration rate study
排除标准
- •EXCLUSION CRITERIA AT REGISTRATION AND RANDOMISATION:
- •1) Metastatic disease on CT imaging. However, patients with positive surgical margins or residual nodal disease that can be encompassed within the radiotherapy field for treatment with curative intent are eligible.
- •2) Uterine sarcoma (apart from carcinosarcoma)
- •3) Active autoimmune disease or history of autoimmune disease that may deteriorate or relapse when receiving an immunostimulatory agent (Appendix 5). Note: participants with the following conditions are not excluded and may proceed subject to further screening:
- •a) autoimmune skin disease not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
- •b) controlled type 1 diabetes mellitus
- •c) hypothyroidism (managed with hormone replacement therapy only)
- •4) Any contraindications to receiving platinum and paclitaxel chemotherapy or pelvic radiation or immune checkpoint inhibitor.
- •5) Serious medical or psychiatric conditions that may prevent compliance with the protocol or compromise assessment of key outcomes of the study
- •6) Participants with other active invasive malignancies, except for non-melanoma skin cancer, or in situ melanoma, or a solid tumour treated with curative intent and no evidence of disease recurrence for more than 3 years.
- •7) Any condition that required systemic treatment with either corticosteroids (>10mg daily of prednisone or equivalent) or other immunosuppressive medication lesser or equal to 14 days before randomisation
- •Note: participants who are currently or have previously been on any of the following steroid regimens are not excluded:
- •a) Adrenal replacement steroid (dose lesser or equal to 10 mg daily of prednisone or equivalent)
- •b) Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
- •c) Short course (lesser or equal to 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a non-autoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen) or as supportive medication for before and after chemotherapy
- •8) Active hepatitis B or hepatitis C virus infection
- •9) A known history of HIV infection
- •10) Known history of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
- •11) Significant acute or chronic infections including but not limited to:
- •Confidential
- •ANZGOG1910/2020 / CTC0299 - ADELE Page 23 of 75 Version 3.0, 26 May 2023
- •a) Participants with active tuberculosis (history of exposure or history of positive tuberculosis test; plus presence of clinical symptoms, physical, or radiographic findings).
- •b) Participants with active bacterial or fungal or viral infection requiring systemic therapy
- •c) Participants with active COVID-19 infection
- •12) Prior allogeneic stem cell transplantation or organ transplantation
- •13) Any of the following cardiovascular conditions:
- •a) Unstable angina
- •b) Any history of acute myocardial infarction lesser or equal to 6 months before randomisation
- •c) Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV (Appendix 4) lesser or equal to 6 months before randomisation
- •d) Any event of ventricular arrhythmia greater or equal to Grade 2 in severity lesser or equal to 6 months before randomisation
- •e) Any history of cerebrovascular accident lesser or equal to 6 months before randomisation
- •f) Unstable pu
研究者
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