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
Study ID
NCT04928807
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Short course radiotherapy sequential camrelizumab and chemotherapy — COMBINATION_PRODUCT
    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

Study Details

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.

Key Dates

Start date
Jul 20, 2021
Status verified
Feb 2026
Primary completion
Mar 1, 2023
Completion
Mar 20, 2028

Study Design

Enrollment
231 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Short course radiotherapy sequential camrelizumab and chemotherapy
    Radiotherapy will employ conformal or intensity-modulated radiation therapy, with a pelvic irradiation dose of 25 Gy/5 Fractions/1 week. Then rest for 1 week after radiotherapy and begin to receive neoadjuvant chemotherapy CAPOX and camrelizumab, for 2 cycles. The patients were operated within 10 weeks after the last radiotherapy, and the surgical method is total mesorectal excision. Postoperative adjuvant therapy will be started 4-6 weeks after surgery, and the adjuvant regimen was the same as that before operation (CAPOX + camrelizumab) for 6 cycles
  • Active Comparator: Long term concurrent chemoradiotherapy and sequential chemotherapy
    The patients received neoadjuvant therapy of CAPOX 2 weeks after long-term concurrent chemoradiotherapy (28\*1.8Gy, during the same period, capecitabine was 825 mg / m2, twice a day, 5 days a week). The patients were operated within 10 weeks after the last radiotherapy. Adjuvant therapy should begin within 4-6 weeks after surgery, and the adjuvant regimen was the same as that before operation (CAPOX) for 6 cycles

Primary Outcome Measure

pathological complete response (pCR) rate [ Time Frame: an expected average of 5 months ]

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