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RECRUITING
NCT06455124
PHASE2
Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
Sponsor: Fudan University
View on ClinicalTrials.gov
Summary
This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-05-08
Completion Date
2029-12-30
Last Updated
2024-06-13
Healthy Volunteers
No
Conditions
Interventions
RADIATION
Radiation
Shor-course radiotherapy: 25Gy/5Fx
DRUG
PD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
DRUG
Capecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
DRUG
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, China