A Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer
brief summary
This is a prospective single-center, single-arm, open-label, phase II study evaluating the safety, activity, and efficacy of regorafenib in combination with lorigerlimab for the treatment of patients with regrowing or locally recurrent pMMR/MSS localized rectal cancer following TNT.
detailed description
Primary Objective:
To assess the major pathological response (MPR) rate following regorafenib plus lorigerlimab and surgical resection in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy. MPR is defined as residual (viable) invasive cancer cells of 0 - 49% within the resected specimen at the time of surgical resection.
Secondary Objectives:
To estimate overall response rate (ORR) based on RECIST 1.1 following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
* To estimate immune-related objective response rate (irORR) based on irRECIST following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy. * To describe the R0 resection rate following neoadjuvant regorafenib plus lorigerlimab and surgical resection in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy. * To summarize pathological response (% tumor viability, ypTNM) in surgically resected specimens following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy. * To estimate time to surgical resection following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy. * To estimate permanent ostomy rate following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy. * To estimate clinical complete response rate following regorafenib and lorigerlimab in patients with locally recurrent or regrowing pMMR/MSS localized rectal cancer after completion of total neoadjuvant therapy.
official title
Phase II Trial of Regorafenib Plus Lorigerlimab in Patients With Locally Recurrent or Regrowing pMMR/MSS Localized Rectal Cancer