This prospective, single-arm study aims to investigate the efficacy and safety of pembrolizumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR/MSS locally advanced rectal cancer patients
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Capecitabine is given orally at 1000mg / m² twice a day from day1-14 every 3 weeks for 3 cycles
Oxaliplatin is given by intravenous infusion at 130mg / m2 on Day 1 every 3 weeks for 3cycles
Bevacizumab is given intravenously at 7.5mg/kg on day 1 every 3 weeks for 3 cycles
Shanghai Changzheng Hospital
Shanghai, China
RECRUITINGR0 resection rate
Percentage of patients who achieve R0 resection
Time frame: 15 weeks
Pathological complete response rate
Percentage of patients who achieve pathological complete response (pCR) based on local investigator
Time frame: 15 weeks
Tumor regression grade (TRG)
Time frame: 15 weeks
Objective response rate
Percentage of patients who achieve partial response (PR) or complete response (CR)
Time frame: 3 years
Incidence of Treatment-Related Adverse Events
Number of adverse events
Time frame: Until 30 days after the last treatment
Surgical complications
Time frame: Until 90 days after surgery
Quality of life score (QoL score)
Assessment of life quality based on EORTC QLQ-C30
Time frame: Until 30 days after the last treatment
Event free survival
Measure of time from study treatment to disease progression or death
Time frame: Up to 3 years
Disease-free survival
Measure of time from the date of surgery to disease relapse or death
Time frame: Up to 3 years
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Pembrolizumab is given intravenously at 200 mg on day 1 every 3 weeks for 3 cycles
One-year or two-year disease-free survival rate
Percentage of patients who achieve disease-free survival lasting for more than one and two years respectively from the date of surgery
Time frame: Up to 2 years
One-year or two-year overall survival rate
Percentage of patients who achieve survival for more than one and two years respectively from date of first dose
Time frame: Up to 2 years