RecruitingPhase 1NCT07104604

Study on the Efficacy and Safety of Neoadjuvant Radiotherapy Combined With Toripalimab, Liposomal Irinotecan, and Capecitabine in the Treatment of pMMR Locally Advanced Rectal Adenocarcinoma With Low Rectal Involvement


Sponsor

Affiliated Cancer Hospital of Shantou University Medical College

Enrollment

59 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluating the efficacy and safety of radiotherapy combined with Tislelizumab, Liposomal Irinotecan, and Capecitabine in patients with locally advanced mid-lower rectal cancer with pMMR.. Patients would be included as:1. Aged between 18-75 years, with no gender restrictions; 2. Biopsy pathology confirmed as pMMR type locally advanced mid-lower rectal adenocarcinoma (tumor lower margin ≤ 10 cm from the anal verge); 3.With the following high-risk factors: T3N+/T4/N2/EMVI+/MRF+/lateral lymph node metastasis/inability to preserve anal function during surgery; 4. No distant metastasis observed in routine chest and abdominal CT scans.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of radiation therapy plus immunotherapy (toripalimab), a new chemotherapy drug (liposomal irinotecan), and capecitabine (an oral chemo pill) before surgery in people with locally advanced rectal cancer. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced rectal cancer confirmed by biopsy — specifically a type called pMMR (proficient mismatch repair) - Your tumor is in the lower part of the rectum (within 10 cm of the anal opening) - You have high-risk features such as lymph node involvement or the tumor being close to surrounding tissue - Your blood counts and organ function are in acceptable range **You may NOT be eligible if...** - Your tumor is MSI-high or dMMR (a different genetic type that responds differently to immunotherapy) - You have distant metastasis (cancer spread to other organs) - You have active autoimmune disease or are on immunosuppressive therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLiposomal Irinotecan

In this study, the novel drug liposomal irinotecan was added, replacing the conventional formulation of irinotecan, and used as an intensified chemotherapy regimen (liposomal irinotecan + capecitabine) combined with immunotherapy and radiotherapy for neoadjuvant treatment of mid-lower rectal cancer.


Locations(1)

Shantou University Medical College Cancer Hospital

Shantou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07104604


Related Trials