Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer

Launched by THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY · Jan 3, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with locally advanced rectal cancer, which means the cancer is located in the rectum and has not spread to distant parts of the body. The treatment involves a short course of radiation therapy followed by a combination of chemotherapy and a medicine called ivonescimab, along with surgery to remove the cancer. The main goal is to see how well this treatment works and how safe it is for patients.

To participate in the trial, patients must be between the ages of 18 and 74 and have a specific type of rectal cancer that meets certain criteria, such as having a tumor close to the anal area or showing signs of aggressive growth on imaging tests. They should have good overall health and organ function. However, patients with certain conditions, like those who have had previous treatments for cancer or specific types of genetic features in their tumors, will not be eligible. If chosen to participate, patients can expect to receive this innovative treatment and will be closely monitored by the medical team throughout the process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ECOG score of 0-1;
• • histologically or cytologically confirmed colorectal adenocarcinoma with non-distant metastasis
• • Tumor distance from anal verge ≦10cm
• • at least one high-risk criterion defined by pelvic MRI: cT stage \>T2 (tumor invades intrinsic muscularis propria by more than 5 mm); Extramural vascular invasion; cN2; Involvement of the rectal mesorectal fascia (tumor or lymph node ≤1mm from the rectal mesorectal fascia); Lateral lymph node short diameter ≥5mm
• • enough organ function
• Exclusion Criteria:
• • with known MSI-H or dMMR
• • Multiple primary adenocarcinomas
• • History of pelvic radiotherapy
• • Previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibody, anti-PD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g., ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immunocellular therapy, and other treatments targeting the immune mechanism of the tumor.