This is a trial investigating the efficacy and safety of Toripalimab combined with bevacizumab and chemotherapy as neoadjuvant therapy in patients with advanced microsatellite instability-high (MSI-H) or DNA mismatch repair-deficient (dMMR) colorectal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
Neoadjuvant therapy: Toripalimab is given by intravenous infusion at 3mg/kg d1 every 2 weeks for 3 cycles. Adjuvant therapy: Toripalimab is given by intravenous infusion at a dose of 240mg every 3 weeks for up to 9 cycles.
Neoadjuvant therapy: Bevacizumab is given by intravenous infusion at 5mg/kg d1 every 2 weeks for 3 cycles.
Neoadjuvant therapy: Irinotecan is given by intravenous infusion at 180mg/m2 d1 every 2 weeks for 2 cycles.
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, China
RECRUITINGPathological complete response rate based on blinded, independent, central review
Percentage of patients who achieve pathological complete response (pCR) based on blinded, independent, central review (BICR).
Time frame: 10 weeks
R0 recession rate
Percentage of patients who achieve R0 recession.
Time frame: 10 weeks
Time to surgery
Measure of time from study treatment to surgery.
Time frame: 10 weeks
Pathological complete response rate assessed by local investigator
Percentage of patients who achieve pathological complete response (pCR) based on assessment of local investigator.
Time frame: 10 weeks
Pathological complete response rate based on blinded, independent, central review (BICR) and the assessment of local investigator
Percentage of patients who achieve pathological complete response (pCR) based on both blinded, independent, central review (BICR) and assessment of local investigator.
Time frame: 10 weeks
Tumor regression grade (TRG)
Time frame: 10 weeks
Objective response rate
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Time frame: Up to 3 years
Event free survival
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
Score of life quality
Accessment of life quality based on EORTC QLQ-C30 and EORTC QLQ-CR29 scale.
Time frame: Until 30 days after the last treatment
Incidence of Treatment-Related Adverse Events
Number of adverse events.
Time frame: Until 30 days after the last treatment