Finding studies
Finding studies
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Maria Carmela Piccirillo, MD
CONTACT
Piera Gargiulo, MD
CONTACT
Lead
National Cancer Institute, Naples
The primary objective is to describe the activity of neoadjuvant dostarlimab in terms of objective response rate (RECIST 1.1). Secondary objectives are: 1. To describe the activity of neoadjuvant dostarlimab in terms of: * complete clinical response rate at 6 and 12 months * time to clinical complete response * duration of clinical complete response * near-complete clinical response rate at 6 and 12 months * duration of near-complete clinical response * duration of objective response * rate of surgery (total mesorectal excision or local excision) * pathological complete response rate * objective response rate (RECIST 1.1) assessed by central radiological review. 2. To describe the safety of neoadjuvant dostarlimab in terms of: Adverse events/SAE incidence and outcome, time and duration of toxicity according to CTCAE v5.0. 3. To descrive the efficacy of neoadjuvant dostarlimab in terms of: event free-survival (EFS), organ preservation at 3 years, time to ditance recurrence and overall survival (OS)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
