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Recruiting Phase 2 NCT06802666

Short-course Radiotherapy Followed by AK112 and CAPOX as Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Trial Parameters

Condition Locally Advanced Rectal Cancer
Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 45
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-10-16
Completion 2026-09-01
Interventions
short-course radiotherapyIvonescimabcapecitabine

Brief 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

Eligibility Criteria

Inclusion Criteria: 1. The subjects voluntarily joined this study, were able to complete the signing of the informed consent form, and had good compliance; 2. Age ≥18 years and ≤75 years, without gender restriction. 3. Histopathologically confirmed locally advanced rectal adenocarcinoma. 4. Participants who are not suitable for standard therapy due to intolerable toxicity, lack of standard therapy, or refusal of standard therapy. 5. Hematological parameters at baseline\* (within 7 days prior to the first dose of study drug) must meet the following criteria: • Hemoglobin ≥90 g/L • Absolute neutrophil count (ANC) ≥1.5×10\^9/L • Platelet count ≥100×10\^9/L • Eosinophils ≤1.5×upper limit of normal (ULN). \*Participants may not have received blood products (including red cell suspensions, plateletpheresis, cryoprecipitate), erythropoietin, or colony-stimulating factor supportive treatment within 7 days prior to blood sampling. 6. Serum biochemical tests at baseline (within 7 days prior to t

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