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

NCT04928807 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2026-02-27

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Tao Zhang, MD · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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
2021-07-20
Primary Completion
2023-03-01
Completion
2028-03-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04928807 on ClinicalTrials.gov