This study is designed to test the efficacy and safety of Total Neoadjuvant Treatment plus SHR1210(an anti-PD-1 Inhibitor) for High-risk locally advanced Rectal Cancer, Meanwhile, screening effective Biomarker base on neoantigen.
The combined treatment model of neoadjuvant chemoradiotherapy treatment + radical rectal resection + adjuvant therapy has become the standard treatment model for locally advanced mid-low rectal cancer, However, the existing evidence shows that this comprehensive treatment method has reached the upper limit of efficacy and cannot continue to reduce the metastatic rate and improve the survival rate. Recent studies have shown that PD-1 antibody inhibitors have excellent curative effects on the treatment of a variety of tumors and have good safety. This study is a single-arm, single-center, prospective, phase II clinical study. It is designed to test the efficacy and safety of Total Neoadjuvant chmoradiation Treatment plus SHR1210 for High-risk locally advanced Rectal Cancer, Meanwhile, screening effective Biomarker base on neoantigen. In this study, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision. This study is designed to recruit 25 patients in all.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Patients will receive 3 cycles induction CapeOX and SHR-1210
CapeOX is a combination chemotherapy regimen with OXA and CAPE, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.
CapeOX is a combination chemotherapy regimen with OXA and CAPE, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.
Beijing Cancer Hospital
Beijing, China
RECRUITINGpathologic complete response rate(pCR rate)
The number of patients with pCR divided by the total number of patients
Time frame: 1 month after surgery
Toxicity of TNT+SHR-1210
Category and grade of adverse event during neoadjuvant chemotherapy
Time frame: 90 days after neoadjuvant treatment
Change of TCR repertoire
Use neoantigen model to find biomarkers related to the effect of TNT+SHR1210 for patients with rectal cancer; compare and analyze the differences in TCR repertoire changes in peripheral blood.
Time frame: 1 week before surgery
Disease-free survival (DFS)
The 3-year DFS will be defined as the percentage of patients alive without local recurrence or distant metastasis of disease at 3 years measured from the date of the administration of treatment.
Time frame: 3 years
Surgical complication rate
Rate of patients who had surgical complications during the perioperative period
Time frame: 30 days after surgery
Major adverse events
Adverse events will be graded using the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
Time frame: 90 days after the last use of SHR-1210
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patients will receive intensity modulated radiotherapy with capecitabine
Patients will receive TME (Total mesorectal excision) following TNT+SHR1210 if no metastasis occurs.