EUCTR2019-004397-26-DK进行中（未招募）1 期
FOLFOX + Immunotherapy with intrahepatic administration of oxaliplatin for patients with multiple non-resectable liver metastasis from colorectal cancer. - IMMUNOX
Department of Oncology, Herlev & Gentofte Hospital0 个研究点目标入组 30 人开始时间: 2019年12月19日最近更新:
适应症
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
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Informed cinsent
- •- Age: 18 – 79 years
- •- Performance status 0-1.
- •- Histologically dokumentet colorectal cancer (In case primary tumor has not yet been removed, it should be possible to be removed by surgery)
- •- Tumor is imminhistochemically MSS
- •- More than 5 liver metastaser, not eligible for liver resection or RFA
- •- Presence of liver metatastasis documented on CT-scan with no documented extrahepatic disease except from primary tumor in situ.
- •- Measurable disease according to RECIST 1.1
- •- Involved liver tissue under 70 %
- •- Perfusion of liver metastasis possible via a. hepatica
- •- ANC >= 1,5 x 10¨9/ml og Platelets >= 100 x 10¨9/ml ,
- •- Estimated creatinine clearence >= 60 ml/min
- •- INR < 1,4 and bilirubin <= 1,5 x ULN
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •- Current or prior second malignancy within 5 years, except from basal cell carcinoma or carcinoma in situ cervicis uteri.
- •- Severe medical condition, such as servere cardiac disease or AMI within 1 år
- •- Uncontrolled infection.
- •- Patients positive for HIV, HBV-sAG or HCV antibody
- •- Participants with active, known or suspected autoimmune disease. Participants with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •- Current or prior use of immunosuppressive medication within 14 days before the first dose of ipilimumab, nivolumab and tocilizumab. The following are exceptions to this criterion:
- •oIntranasal, inhaled, or topical steroids; or local steroid injections (e.g. intra-articular injection)
- •oSystemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
- •oSteroids as premedication for hypersensitivity reactions (e.g. CT scan premedication)
- •- Patients requiring treatment with oral prednisolon of dose > 10 mg daily
- •- Previous severe, unexpected reaction related to treatment with fluoropyrimidine.
- •- Previous treatment with oxaliplatin or immunotherapy
- •- Neuropathy that is contraindicated for treamtment with oxaliplatin
- •- Pregnant or breastfeeding women. Women with childbearing potential (WOBCP) should have a negative pregnancy test and agree to use highly effective method(s) of contraception during treatment and 6 months thereafter.
- •- Men who are sexually active with WOCBP who do not agree to use highly effective method(s) of contraception during treatment and 7 months after immunotherapy or 6 months after chemotherapy (which period is the longest)
- •- Patients who, for linguistic, intellectual or cultural reasons, will not be able to fully understand the concept of treatment and respond to any. complications.
研究者
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