Tislelizumab for Resectable Ultra-low Rectal Cancer
Long-course chemoradiotherapy
+ CAPOX regimen
+ Tislelizumab combined with the CAPOX regimen
Digestive System Diseases+8
+ Digestive System Neoplasms
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: August 1, 2025
Actual date on which the first participant was enrolled.This study focuses on treating patients with a type of rectal cancer called ultra-low rectal adenocarcinoma. It specifically targets individuals whose cancer is resectable, meaning it can potentially be removed by surgery, and who have not previously received treatment. The trial aims to explore the effectiveness of adding a drug called tislelizumab to the standard treatment of chemoradiotherapy followed by chemotherapy. Understanding whether tislelizumab can improve outcomes, such as preserving the anus and delaying or avoiding more invasive surgery, is crucial for enhancing the quality of life for patients with this challenging condition. Participants in the study receive a combination of chemotherapy and radiation therapy, and then some receive additional cycles of chemotherapy with or without tislelizumab. Treatment success is measured by how well the cancer responds, focusing on whether surgery can be avoided and how long patients remain cancer-free. Those who do not respond fully to the initial treatment are advised to undergo a surgery called total mesorectal excision. The study tracks various outcomes like how many people can keep their organ intact over one to three years and overall survival rates, providing important data on the potential benefits and risks of the treatment strategy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.154 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives