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NOT YET RECRUITING
NCT07134218
PHASE2/PHASE3

Neoadjuvant Chemoradiotherapy Combined With Immunotherapy and Anti-angiogenesis in Treating Locally Advanced Rectal Cancer

Sponsor: Changhai Hospital

View on ClinicalTrials.gov

Summary

This is a multicenter, prospective, randomized phase II trial designed to evaluate the efficacy and safety of short-course neoadjuvant chemoradiotherapy combined with the PD-1 monoclonal antibody serplulimab and the anti-angiogenic agent bevacizumab in patients with previously untreated pMMR/MSS middle and low locally advanced rectal cancer. The study plans to enroll a total of 200 participants (100 in the experimental arm and 100 in the control arm).

Official title: A National Multicenter, Prospective, Randomized Controlled Study of Serplulimab Injection Combined With Bevacizumab to Improve the Complete Response Rate of Neoadjuvant Therapy for Locally Advanced Stage Intermediate and Low Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

180

Start Date

2025-10

Completion Date

2027-10

Last Updated

2025-08-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

serplulimab、bevacizumab

short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 2 cycles of FOLFOX + serplulimab + bevacizumab → 2 cycles of FOLFOX + serplulimab.

OTHER

neoadjuvant chemoradiation therapy

short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 4 cycles of FOLFOX alone.

Locations (1)

Department of Colorectal Surgery in Changhai Hospital

Shanghai, Shanghai Municipality, China