Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 12:39 AM
NCT ID:
NCT07223567
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.
Study:
NCT07223567
Study Brief:
Protocol Section:
NCT07223567