Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Dorte Nielsen
With
Danish Cancer Society
Age
18–79
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Informed consent
Age: 18 - 79 years
Performance status 0-1.
Histologically documented colorectal cancer (In case primary tumor has not yet been removed, it should be possible to be removed by surgery)
Tumor is immunohistochemically microsatellite stable (MSS)
You may not be if
Presence of liver metastasis 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 clearance \>= 60 ml/min
INR \< 1,4 and bilirubin \<= 1,5 x ULN
Current or prior second malignancy within 5 years, except from basal cell carcinoma or carcinoma in situ cervix uteri.
Severe medical condition, such as severe cardiac disease or AMI within 1 year
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. The following are exceptions to this criterion:
* Intranasal, inhaled, or topical steroids; or local steroid injections (e.g. intra-articular injection)
* Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
* Steroids 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 treatment with oxaliplatin
Pregnant or breastfeeding women. Women with childbearing potential (WOCBP) 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.
Clareo Health | FOLFOX + Immunotherapy With Intrahepatic Oxaliplatin for Patients With Metastatic Colorectal Cancer
