Neoadjuvant Long-course Chemoradiotherapy Followed by Immunotherapy for Locally Advanced Mid-low Rectal Cancer
NCT06493240 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-11-25
Summary
The purpose of this study was to evaluate the effect of capecitabine-based long-term radiotherapy followed by 3 cycles Sintilimab (PD-1 inhibitor) in patients with locally advanced rectal cancer.
Conditions
- Locally Advanced Rectal Cancer
Interventions
- RADIATION
-
radiation
45 Gy radiation dose in 25 fractions to the pelvis
- DRUG
-
PD-1 Monoclonal Antibody
200mg Sintilimab after radiation (3 times, 2-week interval)
- PROCEDURE
-
TME surgery
TME surgery for 6\~8 weeks after radiation
Sponsors & Collaborators
-
Peking University People's Hospital
lead OTHER
Principal Investigators
-
Zhanlong Zhanlong, M.D. · Peking University People's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-01
- Primary Completion
- 2025-04-01
- Completion
- 2025-04-01
Countries
- China
Study Locations
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