Condition: Rectal Cancer · Neoadjuvant Therapies · Immune Checkpoint Therapy · Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
The goal of this clinical trial is to evaluate whether a total neoadjuvant therapy (TNT) regimen combining long-course chemoradiotherapy, sequential chemotherapy, and PD-1 inhibitor can improve response rates, enhance tolerability, and improve prognosis in patients with locally advanced, microsatellite-stable (MSS) rectal cancer. The main questions it aims to answer are: Does this TNT approach improve complete response (CR) rates? How does selective reduction of clinical target volume (CTV) to S2/S3 level compare with conventional CTV irradiation in terms of efficacy and safety? Researchers will compare a selective CTV reduction group and a conventional CTV irradiation group to assess differences in treatment outcomes, including complete response, tumor regression grading (TRG), organ preservation, R0 resection rates, and long-term survival. Participants will: Receive long-course chemoradiotherapy with either conventional or reduced CTV irradiation. Undergo sequential chemotherapy. Receive PD-1 inhibitor treatment. Be monitored for safety, tumor regression, and long-term survival outcomes.
This description comes directly from the study's public registry record.
Yanxin Luo, M.D., Ph.D. · +86-13826190263 · luoyx25@mail.sysu.edu.cn
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| The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou, Guangdong, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06923345