Neoadjuvant Chemoradiation Therapy Combined With Immunotherapy for MSS Ultra-low Rectal Cancer
NCT05215379 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 201
Last updated 2026-01-02
Summary
At present, there are no relevant studies or reports on the effect of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer. Studied in this paper combin neoadjuvant chemoradiation with immune therapy, carry out "Multicenter prospective randomized clinical trial of neoadjuvant chemoradiation therapy combined with immunotherapy for MSS ultra-low rectal cancer" in order to provide a high-level evidence-based medical evidence for ultra-low rectal cancer treatment and improve ultra-low rectal cancer diagnosis and treatment effect.
Conditions
- Neoadjuvant Chemoradiation Therapy
- Rectal Cancer
- Immunotherapy
- Microsatellite Instability Low
Interventions
- DRUG
-
xintilimab injection
neoadjuvant chemoradiation therapy +xintilimab injection 200mg/3week 4cycle
- OTHER
-
Control
neoadjuvant chemoradiation therapy
Sponsors & Collaborators
-
Changhai Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-01
- Primary Completion
- 2024-12-30
- Completion
- 2025-06-24
Countries
- China
Study Locations
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