EUCTR2017-001845-29-NO进行中（未招募）1 期
METIMMOX: COLORECTAL CANCER METASTASIS – SHAPING ANTI-TUMOR IMMUNITY BY OXALIPLATIN - METIMMOX
Akershus University Hospital0 个研究点目标入组 100 人开始时间: 2024年6月11日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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
- 性别
- All
入选标准
- •Patient has histologically verified colorectal cancer (CRC). Patient is ambulatory with Eastern Cooperative Oncology Group performance status 0 or 1. Patient is at least 18 years of age. Patient has measurable liver-metastatic CRC that can be biopsied. Patient has incurable cancer. Patient has not had previous systemic therapy for the metastatic disease. Patient is eligible for the Nordic FLOX regimen. Patient has the following laboratory values, as measured in serum/plasma within 2 weeks perior to study entry, indicative of adequate organ function:
- •oHemoglobin at least 10.0 g/dL.
- •oNeutrophils at least 1.5 x109/L (without current use of colonystimulating factors).
- •oPlatelets at least 100 x109/L.
- •oC-reactive protein less than 60 mg/L.
- •oAST/ALT no higher than 5xULN (an eligible patient has metastatic disease in the liver).
- •oBilirubin no higher than 2xULN (an eligible patient has metastatic disease in the liver).
- •oAlbumin no lower than 30 g/L.
- •oINR within normal level.
- •oCreatinine no higher than 1.5xULN.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Patient has potentially resectable metastatic disease. Patient is eligible for a first-line systemic regimen that does not contain oxaliplatin. Patient is eligible for a first-line regimen that must contain an inhibitor of EGFR or angiogenesis. Patient is eligible for a triplet chemotherapy regimen. Patient has primary tumor with BRAF mutation. Patient has metastatic disease to lungs as the sole site. Patient has untreated or symptomatic brain metastasis (patient must be symptom-free without the use of corticosteroids). Patient experiences a period of less than 12 months since discontinuation of adjuvant chemotherapy. Patient is ineligible for full chemotherapy doses (100% doses) at start of study treatment. Patient has had radiation therapy within 4 weeks of start of study treatment. Patient has a nervous system disorder worse than CTCAE grade 1. Patient has any medical condition that will preclude him/her from cancer immune-modulating therapy. Patient with current or prior use of immunosuppressive medication within 28 days before the first dose of study therapy, with the exceptions of intranasal corticosteroids or systemic corticosteroids at physiological doses that do not exceed 10mg/day of prednisone or an equivalent corticosteroid. Patient has undergone treatment with any investigational medicinal product that may interfere with the study treatment within 4 weeks prior to first administration of study drug. Patient has history of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB, and stage I prostate cancer considered not necessary to treat. Patient has significant cardiac, pulmonary, or other medical illness that would limit activity of daily life or survival. Patient is pregnant or breastfeeding. Patient has any other reason, in the opinion of Clinical Investigator, not to participate in the study.
研究者
相似试验
招募中
1 期
METIMMOX-2: Oxaliplatin Chemotherapy and Immunotherapy to Patients with the Common pMMR/MSS Type of Large Bowel Cancer Spread to Other OrgansColorectal cancerCTIS2022-500027-76-00Akershus University Hospital40
进行中（未招募）
1 期
evaluation of the standard therapy with FOLFIRI+CEtuximab until disease progression compared to FOLFIRI+Cetuximab for 8 cycles followed by Cetuximab until disease progression in first line treatment of patients with RAS and BRAF wild type metastic colorectal cancerPatients with unresectable, KRAS, NRAS and BRAF wild-type (WT) metastatic colorectal cancer.MedDRA version: 19.0Level: LLTClassification code 10052362Term: Metastatic colorectal cancerSystem Organ Class: 100000004864EUCTR2014-004299-41-ESDipartimento di Scienze mediche Oncologia Medica Policlinico Gemelli600
进行中（未招募）
1 期
Evaluation of the standard therapy with FOLFIRI + Cetuximab until disease progression compared to FOLFIRI + Cetuximab for 8 cycles followed by Cetuximbab until disease progression in first line treatment of patients with RAS and BRAF wild type metastatic colorectal cancer.EUCTR2014-004299-41-ITDipartimento di Scienze Mediche Oncologia Medica Policlinico Gemelli600
进行中（未招募）
1 期
Alternating chemotherapy plus cetuximab to allow resection of metastases from a colorectal cancer that is wild-type KRAS and BRAF - a randomised phase II trial - Nordic 7.6Metastatic colorectal cancer with wild-type KRAS and BRAFMedDRA version: 14.1 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004188-65-SEOdense University Hospital180
已完成
2 期
METIMMOX: Colorectal Cancer METastasis - Shaping Anti-tumor IMMunity by OXaliplatinColorectal Cancer MetastaticNCT03388190University Hospital, Akershus80