This study aims to evaluate the clinical efficacy and safety of anlotinib in combination with penpulimab and conventional chemoradiotherapy for the neoadjuvant treatment of locally advanced rectal cancer
Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14 Radiation therapy 1.8-2Gy/50-55Gy Chemotherapy: Capecitabine 800mg/m2 P.O. BID D1-D14, or capecitabine plus oxaliplatin 130mg/m2. Every 21 days is 1 cycle In the above regimen, two cycles of targeted therapy (chemotherapy + immunotherapy + targeted therapy) are synchronized during radiotherapy; After the end of radiotherapy, two cycles of adjuvant chemo-immunotherapy (chemotherapy + immunotherapy) were continued.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Penpulimab 200mg IV D1 Anlotinib 12mg P.O. QD D1-14
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
Pathologic complete response rate(pCR)
Time frame: assessment 2-4 weeks after surgery
R0 resection rate
Time frame: assessment 2-4 weeks after surgery
Disease-free survival at 3 years
Time frame: from enrollment to three years after surgery
OS at 3 years
Time frame: from enrollment to three years later
RECIST1.1 Objective response rate as assessed
Time frame: 1-2 weeks before surgery
RECIST1.1 Disease control rate evaluated
Time frame: 1-2 weeks before surgery
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