NL-OMON52486招募中2 期
eoadjuvant treatment in rectal cancer with radiotherapy followed by atezolizumab and bevacizumab (TARZAN-trial) - Neoadj treatment in rectalcancer with RT,atezo & beva (TARZAN)
ederlands Kanker Instituut0 个研究点目标入组 38 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
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 64（—）
入选标准
- •- Signed informed consent form
- •- Age >=18 years
- •- Histologically confirmed adenocarcinoma of the rectum, and known
- •microsatellite stability status
- •- Patients with intermediate risk rectal cancer (cT1-3N1 or cT3c/dN0 MRF-) or
- •low risk rectal cancer (cT1-3bN0 MRF-) in patients who wish to pursue organ
- •preservation
- •- No signs of distant metastases on CT of thorax and abdomen, MRI pelvis < 4
- •weeks to inclusion
- •- Patients must be willing to undergo proctoscopy and biopsies prior to start
- •of treatment and during treatment at defined timepoints
- •- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •- Evaluable disease
- •- Adequate hematologic and end-organ function
排除标准
- •- Clinical symptoms or radiological suspicion of perforation
- •- Other malignancies within 3 years prior to registration in the study with
- •the exception of those with a negligible risk of metastasis or death , or
- •treated with expected curative outcome
- •- Prior radiation therapy within 30 days prior to C1D1 and/or persistence of
- •radiation-related adverse effects or previous radiation therapy preventing
- •5x5Gy as specified in this study
- •- Prior allogeneic bone marrow transplantation or solid organ transplant for
- •another malignancy in the past
- •- Spinal cord compression not definitively treated with surgery and/or
- •- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring
- •recurrent drainage procedures
- •- Uncontrolled tumor pain
- •- Treatment with any investigational agent or approved therapy within 28 days
- •or two investigational agent half-lives (whichever is longer) prior to C1D1
- •- Prior treatment with CD137 agonists or immune checkpoint blockade therapies
- •- Current or recent (within 10 days of study enrollment) use of
- •acetylsalicylic acid (> 325 mg/day), clopidogrel (> 75 mg/day) or current or
- •recent (within 10 days of C1D1) use of therapeutic oral or parenteral
- •anticoagulants or thrombolytic agents for therapeutic purposes
研究者
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