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Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Rectal Cancer
Sponsor: The First Affiliated Hospital of Zhengzhou University
Summary
This study is a single-arm, prospective, phase II clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with ivonescimab and chemotherapy + total mesorectal excision(TME) surgery in patients with advanced rectal cancer.
Official title: A Single-arm, Prospective, Phase II Clinical Study of Short-course Radiotherapy Followed by CAPOX and Ivonescimab for Locally Advanced Low-middle Rectal Cancer with a High Risk of Recurrence
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2025-01-20
Completion Date
2031-12-20
Last Updated
2025-01-08
Healthy Volunteers
No
Conditions
Interventions
Ivonescimab (SMT112 or AK112) Injection
Eligible subjects will receive short-course radiotherapy (SCRT), 25Gy/5f/1 week. 1-2 weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 850-1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).