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NCT06923345

Modified Long-Course Radiotherapy Followed by Chemotherapy and PD-1 Inhibitor for MSS/pMMR High-risk Mid/Low LARC (MODIFI-RC-I)

Recruiting now Phase 2 Last updated 18 April 2025
What this trial tests

Phase 2 trial testing Reduced CTV in Rectal Cancer in 80 participants. Currently enrolling.

Timeline
31 March 2025
Primary endpoint
31 December 2027
31 December 2028

Quick facts

Lead sponsorSixth Affiliated Hospital, Sun Yat-sen University
PhasePhase 2
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment80
Start date31 March 2025
Primary completion31 December 2027
Estimated completion31 December 2028
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Rectal Cancer or Neoadjuvant Therapies. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Rectal Cancer

Currently open trials in the same condition.

Other Sixth Affiliated Hospital, Sun Yat-sen University trials

Trials by the same sponsor.

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Data sources for this page

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