drugset / Trial / NCT04928807
Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)
Phase 3
Active not recruiting
231 enrolled
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Jiangsu HengRui Medicine Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The study is a multicenter, open-label, randomized controlled clinical study, and the purpose of the study is to compare the pathological complete response rate (PCR) of patients with locally advanced rectal cancer treated with short-term radiotherapy, sequential Camrelizumab and CAPOX (group A) to long-term concurrent chemoradiotherapy, sequential CAPOX (group B) in patients with LARC. A total of 230 patients were included in this study.
Timeline
- Start
- 2021-07-20
- Primary completion
- 2023-03-01
- Completion
- 2028-03-20
Publications
- You Q, Jin M, Zhou B, Huang C, Lin Z, Hu J, Xue J, Chen X, Xiao Y, Li R, Zong Y, Wu M, Zhang T, Liu H. Gut microbiome components predict response to neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): a prospective study. Front Pharmacol. 2026 May 29;17:1829108. doi: 10.3389/fphar.2026.1829108. eCollection 2026.
- Zhang F, Yu D, Yang J, Zhai M, Li L, Zhao L, Wang J, Zhang T, Lin Z. Pretreatment high cholesterol and low neutrophils predict complete pathological response after neoadjuvant short-course radiotherapy followed by chemotherapy and immunotherapy in locally advanced rectal cancer. Oncol Lett. 2023 Jun 7;26(1):319. doi: 10.3892/ol.2023.13905. eCollection 2023 Jul.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Camrelizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Background | Oxaliplatin | Small molecule | 130 mg/m2 | Intravenous |