CTIS2022-500027-76-00招募中1 期
METIMMOX-2: Metastatic pMMR/MSS Colorectal Cancer – Shaping Anti-Tumor Immunity by Oxaliplatin - METIMMOX-2
Akershus University Hospital0 个研究点目标入组 40 人开始时间: 2022年2月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
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 65+（—）
- 性别
- All
入选标准
- •Patient has histologically verified CRC adenocarcinoma., Patient has radiologically measurable metastatic disease., Patient has not had previous systemic cytotoxic therapy for the metastatic disease, except for previous neoadjuvant treatment., Patient is eligible for the Nordic FLOX chemotherapy regimen.
排除标准
- •Patient has initially resectable metastatic disease for which systemic therapy is deemed superfluous., Patient has Eastern Cooperative Oncology Group (ECOG) performance status 2 or worse., Patient has serum/plasma C-reactive protein (CRP) of 60 mg/L or higher., Patient does not meet the following requirements at baseline: adequate bone marrow function without current use of colony-stimulating factors (minimum values of neutrophils 1.5 x10e9/L, platelets 100 x10e9/L, hemoglobin 10 g/dL), adequate liver function (maximum values of AST/ALT 5 xULN and bilirubin 2 xULN; albumin value of 30 g/L or higher; INR within normal level), adequate renal function (maximum creatinine value of 1.5 xULN), protein in urine less than 2+ by dipstick (within 14 days prior to initiation of study treatment)., Patient has any other reason, in the opinion of Clinical Investigator, not to participate in the study., Patient does not present any infradiaphragmatic metastatic manifestation., Patient has untreated or symptomatic brain metastasis (patient must be symptom-free without the use of corticosteroids)., Patient experiences a period of less than 6 months since discontinuation of neoadjuvant or adjuvant oxaliplatin-containing chemotherapy., Patient is ineligible for full (100%) chemotherapy doses at first treatment cycle., Patient has had radiation therapy against the only measurable lesion within 4 weeks of start of study treatment., Patient has a nervous system disorder worse than grade 1 of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0., Patient has any medical condition or has undergone any treatment within 4 weeks of start of study treatment that will preclude him/her from cancer immune therapy., Patient has any medical condition that will preclude him/her from receiving a component of the FLOX regimen.
研究者
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