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Node-sparing Radiotherapy Combined with Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer
Sponsor: Jinhua Central Hospital
Summary
phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.
Official title: Total Neoadjuvant CAPOX and PD-1 Inhibitor(Sintilimab) Combined with Node-sparing Short-course Radiotherapy for MSS Locally Advanced of Middle and Low Rectal Cancer(CASINOs): an Open Label, Single-arm, Prospective Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2024-02-05
Completion Date
2028-09-01
Last Updated
2025-01-07
Healthy Volunteers
No
Conditions
Interventions
node-sparing short-course radiotherapy
5Gy\*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes
Sintilimab
200mg intravenous infusion d1 of each cycle\*8cycles
Capecitabine
1000mg/m2, PO, BID, d1-14 of each cycle\*8cycles
Oxaliplatin
130mg/m2, intravenous infusion,d1 of each cycle\*8cycles
TME surgery
laparoscopic or robotic TME surgery for non-cCR patients
watch and wait
WW for cCR patients
Locations (1)
Zhejiang University Affiliated Jinhua Hospital
Jinhua, Zhejiang, China