This is an open, prospective, multi-center, single-arm phase II clinical study assessing the efficacy and safety of neoadjuvant chemoradiotherapy combined with PD-1 inhibitor and thymalfasin in patients with pMMR/MSS locally advanced middle and low rectal cancer.
This study is an open, prospective, multi-center, single-arm phase II clinical study. In this study, patients with pMMR/MSS locally advanced middle and low rectal cancer were selected as the subjects and treated with neoadjuvant treatment protocol of long-course concurrent chemoradiotherapy combined with PD-1 monoclonal antibody and thymalfasin. The primary endpoint of the study was complete response (CR) rate. The secondary end points included treatment-related adverse events (TRAEs) rate, 30-day incidence of postoperative complications, objective response rate (ORR), 3-year disease-free survival (DFS) rate, Neoadjuvant rectal cancer (NAR) score, R0 resection rate, and anal preservation rate.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Beijing Friendship Hospital,Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
CR rate
complete response rate, If patients achieved cCR after neoadjuvant therapy or were confirmed pCR after TME, they were considered as complete response (CR). pCR was defined as no residual tumor cells on the histologic examination of surgical specimens according to AJCC 8th edition. cCR was defined according to the Memorial Sloan Kettering Cancer Center (MSKCC) standard.
Time frame: from preoperative to 10 days postoperative
TRAE
incidence of treatment-related adverse event
Time frame: from commencing of treatment to the 30th day after surgery
30-day incidence of postoperative complications
incidence of surgical complications within 30 days after surgery
Time frame: within 30 days after surgery
ORR
objective response rate; The ORR rate is the result of complete response (CR) rate plus partial response (PR) rate.
Time frame: before surgery
3-y DFS rate
3-year disease free survival rate
Time frame: 3 years
NAR score
neoadjuvant rectal score
Time frame: within 10 days after surgery
R0 resection rate
rate of R0 resection
Time frame: within 10 days after surgery
anal preservation rate
proportion of patients with preserved anal sphincter
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50 Gy/25 f, 2 Gy/day
Time frame: instantly after surgery