Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599827
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk LARC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Moderately Hypofractionated Radiotherapy Combined with Chemotherapy and Immunotherapy for High-risk PMMRMSS Locally Advanced Rectal Cancer a Prospective Exploratory Phase II TrialiMHRT-LARC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iMHRT-LARC
Brief Summary:
This study aims to evaluate the effectiveness and safety of combining moderately hypofractionated radiotherapy with chemotherapy and anti-PD-1 antibodies as a neoadjuvant treatment for high-risk locally advanced rectal cancer
Detailed Description:
This study investigates a novel treatment approach involving moderately hypofractionated radiotherapy 3-35Gy10 combined with chemotherapy and immunotherapy for patients with high-risk locally advanced rectal adenocarcinoma aiming to optimize treatment efficacy and patient outcomes
Neoadjuvant chemoradiotherapy followed by total mesorectal excision TME is the standard of care for locally advanced rectal cancer improving surgical resection rates local control and sphincter preservation Conventional long-course radiotherapy is the standard modality for neoadjuvant therapy but it has drawbacks such as long treatment duration high cost and prolonged preoperative waiting time Short-course radiotherapy on the other hand offers shorter treatment duration lower cost and shorter preoperative waiting time but it is associated with higher rates of local recurrence Immunotherapy has demonstrated promising anti-tumor activity in colorectal cancers with deficient mismatch repair dMMR andor microsatellite instability-high MSI-H status but its role in proficient mismatch repair pMMR andor microsatellite stable MSS colorectal cancers remains unclear However studies have shown that the combination of chemoradiotherapy and immunotherapy can increase the pathologic complete response rate compared to chemoradiotherapy alone suggesting that radiotherapy may serve as a stimulator of adaptive immunity and synergize with immunotherapy Therefore this study aims to explore the following regimen neoadjuvant moderately hypofractionated radiotherapy at a dose of 35 Gy 10 fractions to the tumors and 3 Gy 10 fractions to the pelvic lymph node drainage area combined with chemotherapy capecitabine and oxaliplatin and immunotherapy Serplulimab
This prospective single-center non-randomized Phase II trial is designed to explore the efficacy and safety of the treatment regimen Patients will receive CapeOx chemotherapy anti-PD-1 monoclonal antibody immunotherapy and a course of moderately hypofractionated radiotherapy The trial protocol prioritizes safety monitoring and efficacy assessments through standardized clinical and imaging evaluations
Neoadjuvant chemoradiotherapy followed by total mesorectal excision TME is the standard of care for locally advanced rectal cancer improving surgical resection rates local control and sphincter preservation Conventional long-course radiotherapy is the standard modality for neoadjuvant therapy but it has drawbacks such as long treatment duration high cost and prolonged preoperative waiting time Short-course radiotherapy on the other hand offers shorter treatment duration lower cost and shorter preoperative waiting time but it is associated with higher rates of local recurrence Immunotherapy has demonstrated promising anti-tumor activity in colorectal cancers with deficient mismatch repair dMMR andor microsatellite instability-high MSI-H status but its role in proficient mismatch repair pMMR andor microsatellite stable MSS colorectal cancers remains unclear However studies have shown that the combination of chemoradiotherapy and immunotherapy can increase the pathologic complete response rate compared to chemoradiotherapy alone suggesting that radiotherapy may serve as a stimulator of adaptive immunity and synergize with immunotherapy Therefore this study aims to explore the following regimen neoadjuvant moderately hypofractionated radiotherapy at a dose of 35 Gy 10 fractions to the tumors and 3 Gy 10 fractions to the pelvic lymph node drainage area combined with chemotherapy capecitabine and oxaliplatin and immunotherapy Serplulimab
This prospective single-center non-randomized Phase II trial is designed to explore the efficacy and safety of the treatment regimen Patients will receive CapeOx chemotherapy anti-PD-1 monoclonal antibody immunotherapy and a course of moderately hypofractionated radiotherapy The trial protocol prioritizes safety monitoring and efficacy assessments through standardized clinical and imaging evaluations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None