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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 2 cycles of FOLFOX + serplulimab + bevacizumab → 2 cycles of FOLFOX + serplulimab.
short-course radiotherapy 25 Gy in 5 fractions → 2-week break → 4 cycles of FOLFOX alone.
Department of Colorectal Surgery in Changhai Hospital
Shanghai, Shanghai Municipality, China
The rate of cCR
Rate of patients who achieve clinical complete response
Time frame: 2 years
Major Pathological Response
Rate of major pathological response assessed by postoperative pathology
Time frame: 2 years
Objective Response Rate
Objective response rate assessed by RECIST 1.1 criteria
Time frame: 2 years
Disease-Free Survival (DFS)
DFS was defined as the duration from the date of randomization to the date of the first recurrence (local, distant, or mixed) or death.
Time frame: 2 years
Overall Survival (OS)
Time from randomization to death due to any cause
Time frame: 2 years
Organ Preservation Rate (OPR)
Proportion of patients who achieve organ preservation by choosing a watch-and-wait strategy or local excision after attaining clinical or pathological complete response
Time frame: 2 years
Neoadjuvant Rectal Score (NAR)
Neoadjuvant rectal score assessed by postoperative pathology
Time frame: 2 years
Quality of Life Score (QoL)
Quality of life score during treatment and follow-up
Time frame: 2 years
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Safety and Tolerability
Incidence of adverse events (AEs), incidence of abnormal laboratory values, and dose adjustments during treatment and follow-up
Time frame: 2 years