Clinical Research Directory

SCRT Followed by CAPOX + Bev ± PD-1 Inhibitor for TNT in LARC

This study aims to evaluate the efficacy and safety of short-course radiotherapy combined with CAPOX plus bevacizumab with or without a PD-1 inhibitor in patients with locally advanced rectal cancer (LARC). The hypothesis is that the addition of immunotherapy (PD-1 inhibitor) can significantly improve the complete response (CR) rate and enhance local control while reducing the incidence of distant metastasis. This study will compare the effects of sequential chemoradiotherapy and targeted therapy with or without immunotherapy following short-course radiotherapy, aiming to explore the optimal regimen for total neoadjuvant therapy.

Walking and Sitting Difficulties After Rectal Cancer Surgery

Earlier studies have shown that many patients (up to 30%) who have had a major surgery for rectal cancer, called a rectum amputation (where the entire rectum and anus are removed and the person gets a permanent stoma), still have trouble sitting and walking three years after the surgery. These problems are then seen as long-term or chronic. WASA is a randomized multicenter international study that will test a way to reduce these problems. It will start in fall 2025 and go on for 3.5 years. About 300 patients will take part. The patients will be randomly divided into two groups. One group will get guided online training twice a week, specially made for their needs. The other group will get information about the World Health Organization's (WHO) general advice on physical activity. The idea is that special training during the first year after surgery will reduce problems with walking and sitting. If the hypothesis can be confirmed, it could lead to an easy and low-cost way to help many rectal cancer patients feel and function better.

Efficacy of Mepilex Lite Dressings in Treating Anal Pain

BACKGROUND: Rectal cancer is a common gastrointestinal tumor, and low and intermediate rectal cancer accounts for 90% of rectal cancer. Radiotherapy is one of the important means of rectal cancer treatment, but the radiotoxicity induced by radiotherapy should not be neglected. As normal tissues around the target organ of radiotherapy, the anal canal is damaged by radiation and mucous membrane damage occurs, which is manifested as mucous membrane congestion, edema and ulceration, etc., and pain in the anal area occurs. With the accumulation of radiotherapy dose, the mucosal damage of the anal canal becomes more and more serious, and the anal pain of the patients is severe, which seriously affects the life quality of the patients. Therefore, the main objective of this study is to determine the effectiveness of mepilex lite dressings combined with indomethacin suppositories in the treatment of anal pain in patients undergoing radiotherapy for low and intermediate rectal cancer. METHODS: The study protocol will be a single-blind randomized controlled trial. A randomized grouping method was used to divide the participants into an observation group (n=98) and a control group (n=98). The control group was given routine nursing measures, and the experimental group was given mepilex lite dressings for intra-anal insertion combined with indomethacin suppository for anal administration on the basis of routine nursing measures. The primary outcome indicator was anal pain score. Secondary outcome indicators were anxiety score, sleep quality score and comfort score. Assessments were made at baseline (anal pain NRS score ≥7 in patients undergoing radiotherapy for low to intermediate rectal cancer), day 1, day 7 and day 14 post-intervention. Statistical analyses will be performed using SPSS 25.0 and a significance level of p≤0.05 will be used for all tests.

PRediction of Outcomes and PERsonalized Radiotherapy by Biomarkers and Functional Imaging

This is a study focused on analyses of peripheral blood (tissue study). The aim of the trial is to determine whether it is possible to predict early clinical and/or pathological responses after radiotherapy in the setting of neoadjuvant treatment for locally advanced rectal carcinomas, through qualitative and quantitative assessment of circulating extracellular vesicles in plasma and the microRNA (miRNA) contained within them. Extracellular vesicles are "clean-up" structures that collect various elements circulating in the blood, including fragments of DNA and RNA from tumor cells. Observing how these structures and their contents change with radiotherapy could provide early indications of the tumor's response to treatment. The trial seeks to answer the question: "Can the quantity of CD69+ vesicles in patients undergoing neoadjuvant radiotherapy predict their response early?" The trial is monocentric and plans to enroll approximately 30 patients. Participation in this trial does not offer direct benefits, as it involves only laboratory investigations without modifications to the usual diagnostic-therapeutic process for the condition considered. The collection of information is aimed at improving knowledge regarding extracellular vesicles. These vesicles could provide early insights into the response to neoadjuvant radiotherapy for locally advanced rectal tumors. In this way, subsequent therapeutic strategies can be personalized based on this response.