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
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Endometrial Cancer
- 发起方
- The University of Sydney
- 入组人数
- 135
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
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)
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.
结局指标
主要结局
未指定
相似试验
尚未招募
2 期
Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal CancerImmunotherapyNCT05479240Fujian Cancer Hospital94
招募中
2 期
Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma.Advanced Esophageal Squamous Cell CancerNCT05323890Shandong Cancer Hospital and Institute15
尚未招募
2 期
Neoajuvant Tislelizumab Combined with Chemotherapy for Initially Unresectable Stage IIIA/N2 Non-small Cell Lung CancerNSCLC, Stage IIIANSCLC (non-small Cell Lung Cancer)NCT06614231Sun Yat-sen University48
进行中（未招募）
2 期
Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon CancerColonic NeoplasmsNeoadjuvant TherapyImmune Checkpoint InhibitorsNCT06124378First Affiliated Hospital of Guangxi Medical University60
招募中
4 期
Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung CancerNon-small-cell Lung Cancer (NSCLC)NCT06357598The Affiliated Hospital of Qingdao University30