CTIS2023-509851-15-00进行中（未招募）1 期
A PRECISION MEDICINE TRIAL LEVERAGING BLOOD-BASED TUMOR GENOMICS TO OPTIMIZE TREATMENT IN OPERABLE STAGE III AND HIGH-RISK STAGE II COLON CANCER PATIENTS - IFOM-CPT0092022PO008
Ifom Istituto Fondazione Di Oncologia Molecolare Ets In Breve Ifom Ets0 个研究点目标入组 700 人开始时间: 2024年2月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
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
- •SAGITTARIUS trial written informed consent., Age = 18 years., Histologically confirmed diagnosis of operable stage III and High-Risk stage II colon cancer located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery., Availability of the original FFPE tumor tissue., ECOG performance status 0-1., Normal organ functions (as defined in section 8.3 of the Protocol)., Women with childbearing potential (WOCBP) should complete a pregnancy test and be willing to use highly effective contraceptive methods.
排除标准
- •History of another neoplastic disease, unless in remission for = 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded., Has a known DPD (DihydroPyrimidine Dehydrogenase) deficiency., Has a known Gilbert Syndrome or UGT1A1 homozygous *28/*28 germline variant., Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required., Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus infection, Has a known history of active TB (Bacillus Tuberculosis)., Had an incomplete diagnostic colonoscopy., Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage)., Recent polyps’ removal (within one month)., Current or recent treatment with another investigational drug or participation in another investigational study., Patient unable to comply with the study protocol owing to psychological, social or geographical reasons., Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study., Inadequate contraception (male or female patients) if of childbearing or procreational potential., Clinically relevant cardiovascular disease., Acute or subacute intestinal occlusion or history of inflammatory bowel disease or any other autoimmune disease., Has a medical condition that contraindicate the use of the investigational medicinal product (IMP) according to product indications., Pre-existing neuropathy > grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.
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