Colorectal cancer ranks as the third most prevalent malignancy worldwide and the second leading cause of cancer-related mortality. For patients with locally advanced rectal cancer (LARC) classified as T3-4/N+ without distant metastasis, achieving organ preservation and functional integrity while pursuing curative treatment remains a formidable clinical challenge. This study aims to evaluate the efficacy and organ preservation rates of a novel neoadjuvant regimen comprising short-course radiotherapy followed by four cycles of CAPEOX combined with Iparomlimab and Tuvonralimab in patients with microsatellite stable (MSS) or mismatch repair proficient (pMMR) LARC. Furthermore, the project will investigate potential predictive biomarkers for complete response (CR) within this immunotherapy-based total neoadjuvant therapy (iTNT) paradigm.
Sign a written Informed Consent Form (ICF) and be able to comply with the visits and related procedures stipulated in the protocol
Age between 18 and 75 years old
Histologically confirmed rectal adenocarcinoma
According to the AJCC 8th Edition staging, imaging evaluation (enhanced CT or enhanced MRI) confirms resectable locally advanced rectal cancer (AJCC 8th Edition staging cT3-4 / cN+)
Patients with rectal cancer who have been tested for microsatellite instability as MSI-H or mismatch repair as dMMR
Patients who have previously received any anti-tumor treatment for the studied disease, including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. This includes previous treatment with anti-PD-1, anti-PD-L1, anti-programmed death receptor ligand 2 (PD-L2) or anti-cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) drugs, or any other drugs acting on T cell co-stimulation or immune checkpoint pathways (such as OX40, CD137, etc.), as well as adoptive cell immunotherapy
Simultaneous participation in another clinical study, unless participating in an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study
Treatment with any investigational drug or device within 4 weeks prior to the first dose of the study drug
First Affiliated Hospital of Zhejiang University
Lead sponsor
Ningbo No.2 Hospital
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator
Second Affiliated Hospital of Wenzhou Medical University
Collaborator
Ningbo No. 1 Hospital
Collaborator
The Affiliated People's Hospital of Ningbo University
Collaborator
Taizhou Hospital
Collaborator