Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer
NCT06802666 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2025-01-31
Summary
This study aims to evaluate the efficacy and safety of short-course radiotherapy followed by AK112 in combination with CAPOX as neoadjuvant therapy in patients with locally advanced rectal cancer
Conditions
- Locally Advanced Rectal Cancer
- Neoadjuvant Therapy
Interventions
- RADIATION
-
short-course radiotherapy
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with AK112 regimen for 6 cycles.
- DRUG
-
AK112 20 mg/kg, intravenous infusion every 3 weeks (Q3W)
- DRUG
-
1000mg/m2, bid, po, d1-14,q3w
- DRUG
-
130mg/m2, ivgtt, d1,q3w
- PROCEDURE
-
TME surgery
The surgery was performed 1 week after the end of neoadjuvant therapy.
Sponsors & Collaborators
-
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Tao Zhang, MD · Union Hospital affiliated to Tongji Medical College of Huazhong University ofScience and Technology
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
- 2024-10-16
- Primary Completion
- 2026-09-01
- Completion
- 2027-12-30
Countries
- China
Study Locations
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