Neoadjuvant short-course radiotherapy followed by chemotherapy plus camrelizumab versus long-course chemoradiotherapy followed by chemotherapy for patients with locally advanced rectal cancer: A randomized, multicenter, open-label phase 3 trial (Union).

Authors

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Zhenyu Lin

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

Zhenyu Lin , Peng Zhang , Zhiguo Hou , Kaixiong Tao , Tao Zhang

Organizations

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China, Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Cancer Center, Wuhan, China

Research Funding

Pharmaceutical/Biotech Company
Jiangsu Hengrui Pharmaceuticals Co, Ltd, Shanghai, China

Background: Short-course preoperative radiotherapy (SCPRT) and long-course chemoradiotherapy (LCCRT) are standard neoadjuvant treatments for locally advanced rectal cancer (LARC). Further, the RAPIDO trial found that SCPRT combined with consolidation chemotherapy produced better short- and long-term outcomes than SCPRT alone for patients with high-risk LARC. A phase 2, single-arm trial of neoadjuvant SCPRT followed by camrelizumab (an anti-PD-1 antibody) plus chemotherapy demonstrated promising short-term outcomes in patients with LARC. The Union trial is evaluating the efficacy and safety of neoadjuvant SCPRT followed by camrelizumab plus chemotherapy versus LCCRT followed by chemotherapy in patients with LARC. Methods: The Union trial is enrolling patients aged 18-75 with histologically confirmed clinical stage T3-4/N+ adenocarcinoma of the rectum, Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and a tumor inferior margin less than 10 cm above the anal verge. Eligible patients are randomized in a 1:1 ratio to either arm A or arm B. Patients in arm A receive neoadjuvant treatment with SCPRT (a total of 25 Gy in 5 days) followed by camrelizumab (200 mg/m2 intravenous drip on day 1, every 3 weeks for 2 cycles) plus CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 hours on day 1, capecitabine 1000 mg/m2 oral twice daily, days 1–14, every 3 weeks for 2 cycles), surgery, and adjuvant treatment with camrelizumab plus CAPOX (6 cycles) followed by camrelizumab until the medication duration of camrelizumab reaches one year. Patients in arm B receive neoadjuvant treatment with LCCRT (capecitabine 825 mg/m2 twice daily, 5 days a week, combined with a total dose of 50.4 Gy in 28 days) followed by CAPOX (2 cycles), surgery, and adjuvant treatment with CAPOX (6 cycles). Randomization is stratified by clinical T stage (≤T3 vs T4) and clinical N stage (N0 vs N+). The primary endpoint is pathologic complete response (pCR). The secondary endpoints are 3-year event-free survival rate, overall survival, R0 resection rate, completion rate of neoadjuvant treatment, 3-year disease-free survival rate, tumor regression grading, safety, and quality of life. pCR is evaluated per the AJCC 8th Edition TRG scoring system as assessed by the blinded independent central review. Adverse events are graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Quality of life is assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. This study began enrollment in July 2021 with a planned enrollment of 230 patients. Clinical trial information: NCT04928807.

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Abstract Details

Meeting

2023 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal Cancer—Colorectal and Anal

Track

Gastrointestinal Cancer—Colorectal and Anal

Sub Track

Colorectal Cancer–Local-Regional Disease

Clinical Trial Registration Number

NCT04928807

Citation

J Clin Oncol 41, 2023 (suppl 16; abstr TPS3638)

DOI

10.1200/JCO.2023.41.16_suppl.TPS3638

Abstract #

TPS3638

Poster Bd #

331a

Abstract Disclosures