5 полученные результаты
Investigation type: Premarket study to receive a CE marking, followed by post-marketing surveillance follow-up.
Investigation design: Multi-centre, prospective, non-randomized, observational study
Investigation objectives:
The primary objective is to confirm the safety and efficacy of the H1 hip
Primary Objective
Phase Ib: To determine the safety and tolerability of Y-90 radioembolization therapy when given in conjunction with neoadjuvant/adjuvant nivolumab as assessed by CTCAE version 4, in patients with metastatic colorectal cancer who undergo Y-90 radioembolization to hepatic metastases
PRIMARY OBJECTIVES:
I. To identify MTD of nivolumab for combination treatment of nivolumab and Y-90 in this population.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients with objective response rate (ORR) (according to Response Evaluation Criteria in Solid Tumors [RECIST] criteria) to
Study visits and parameters to be measured
All visits in this study will be performed at the University of California, San Diego Dermatology Clinic, 3rd floor, 8899 University Center Ln., San Diego, California 92109.
Baseline Visit and Laser exposures (Visit 1)
This visit is expected to take
With a prevalence of 1 in 3-5000 births, neurofibromatosis Type I is one of the most common genetic defects. The mode of inheritance is autosomal dominant and affects a gene (NF1), which is responsible for the production of the tumor suppressor protein neurofibromin. The consequence is an