Liver metastasis from colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Department of Oncology, Herlev & Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - 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: o Intranasal, inhaled, or topical steroids; or local steroid injections (e.g. intra-articular injection) o Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent o 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Disease free survival at 3 years;Secondary Objective: a) Number of patients that become eligible for liver resection/RFA during treatment due to reduced tumorburden b) Progression free survival c) Overall survival d) Objective response rate e) Safety Exploratory translational research f) immunological response in liver metastasis g) Biomarker analysis ;Primary end point(s): Fraction of patients that are disease-free (without surgery/RFA of liver metastasis) at 3 years;Timepoint(s) of evaluation of this end point: 3 years after treatment start for last patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Number of patients with tumorburden getting reduced, so patient become eligible for liver resection/RFA b) Time from treatment start to PD or Death, median PFS determined using Kaplan-Meier analyses c) Time from treatment start Death, median OS determined using Kaplan-Meier analyses d) Objective Response (CR, PR) rate at 16 weeks e) Incidence of treatment related AE ;Timepoint(s) of evaluation of this end point: At the end FU (3 years after treatment start for last patient ) | — |
Countries
Denmark
Contacts
Public ContactPI Ole Larsen
Department of Oncology, Herlev & Gentofte Hospital
Outcome results
None listed