Viewing Study NCT06455124



Ignite Creation Date: 2024-06-16 @ 11:52 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06455124
Status: RECRUITING
Last Update Posted: 2024-06-13
First Post: 2024-06-06

Brief Title: Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer TORCH-LE
Sponsor: Fudan University
Organization: Fudan University

Study Overview

Official Title: Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer TORCH-LE
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy
Detailed Description: A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included

Eligibility criteria include a histological diagnosis of adenocarcinoma located 7 cm from the anal verge pT1 after local excision of the primary rectal cancer with one of the high-risk features including margin positivityvery close margin 1mm at time of local excision depth of invasion 1 mm or SM3 invasion submucosal invasion to the lower third of the submucosal level high grade or poorly differentiated lymphovascular invasion perineural invasion tumour budding or pT2 tumor

They will receive 55Gy short-course radiotherapy followed by 4 cycles of capecitabine plus oxaliplatin CAPOX chemotherapy and PD-1 antibody

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None