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ACTIVE NOT RECRUITING
NCT04928807
PHASE3

Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in Locally Advanced Rectal Cancer (UNION)

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Open-label, Controlled Phase III Clinical Trial of Short-Course Radiotherapy Followed by Neoadjuvant Chemotherapy and Camrelizumab in the Treatment for Locally Advanced Rectal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

231

Start Date

2021-07-20

Completion Date

2028-03-20

Last Updated

2026-02-27

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Short course radiotherapy sequential camrelizumab and chemotherapy

Short course radiotherapy, 5 \* 5Gy, once a day, 5Gy each time, for 5 days, continuous irradiation, three-dimensional 3D-CRT or IMRT technology is recommended camrelizumab 200 mg , D1, intravenous drip, q3w, 2 cycles before operation, postoperative adjuvant treatment, the longest medication time of camrelizumab was less than 1 year during the whole study period; Capecitabine 1000 mg / m2, twice a day, oral, 1-14 days, then rest for 7 days, q3w, 2 cycles before operation and 6 cycles after operation; Oxaliplatin 130 mg / m2, D1, intravenous infusion 2 hours, q3w, 2 cycles before operation, 6 cycles after operation

Locations (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China