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Long-Course Concurrent Chemoradiotherapy With Adebrelimab and Apatinib as Neoadjuvant Therapy for Locally Advanced/Low-Lying Rectal Cancer Requiring Sphincter Preservation
Sponsor: Harbin Medical University
Summary
To observe and evaluate the efficacy and safety of neoadjuvant long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib Mesylate in the treatment of locally advanced rectal cancer and low-lying rectal cancer with sphincter-preservation demand.
Official title: A Phase II Clinical Study of Long-Course Concurrent Chemoradiotherapy Combined With Adebrelimab and Apatinib as Neoadjuvant Therapy for Locally Advanced/Low-Lying Rectal Cancer With Sphincter-Preservation Demand
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2026-05-29
Completion Date
2029-05-29
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib
Long-course concurrent chemoradiotherapy regimen: 45-50 Gy administered in 25 fractions, with concurrent capecitabine 1650 mg/m²/day, bid on days 1-14, every 3 weeks as one cycle. Adebrelimab: 1200 mg, intravenous infusion, on D1, once every 3 weeks. Apatinib: 250 mg, orally, 5 days on and 2 days off; if the patient cannot tolerate the toxicity, the dose may be reduced to 125 mg once daily. Each cycle is 21 days, with a total of 6 cycles of neoadjuvant therapy before surgery. Efficacy evaluation is performed after every 2 cycles. After 6 cycles of long-course concurrent chemoradiotherapy combined with Adebrelimab and Apatinib, the research team will reassess the patient. For resectable patients, surgery will be performed 4-6 weeks after neoadjuvant therapy. For patients who decline surgery or are deemed unfit for surgery after 6 cycles, if the investigator believes that continued treatment with Adebrelimab and Apatinib may still provide benefit, the treatment may be continued until
Locations (1)
No. 150, Haping Road, Nangang District, Harbin, Heilongjiang Province, China
Harbin, Heilongjiang, China