The study is a multicenter, open-label, phase II clinical study, and the purpose of the study is to explore the complete response rate (CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR)) of patients with RAS/BRAF wild type locally advanced rectal cancer(LARC) treated with short-term radiotherapy, sequential HLX07, Serplulimab and CAPOX. A total of 29 patients were included in this study.
Patients with RAS/BRAF wild type locally advanced rectal cancer (T3-4/N+) , combined risk factors, will be treated with neoadjuvant therapy, and the Primary endpoint of the study is complete response rate(CR, Defined as pathological complete response (pCR) + Clinical complete response (cCR) ). PCR assessed by the blind independent review committee (BIRC), defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0). CCR evaluation was based on a combination of digital rectal examination, endoscopy, rectal MRI and blood carcinoembryonic antigen levels.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Short course radiotherapy sequential HLX07, Serplulimab and chemotherapy
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, China
RECRUITINGcomplete response (CR) rate
Defined as pathological complete response (pCR) + Clinical complete response (cCR)
Time frame: an expected average of 12 months
3-year disease-Free Survival
The time from the first day of disease free (operation date) to local or distant recurrence, or the death event caused by any reason, whichever occurs first
Time frame: an expected average of 3 years
Overall Survival
The time from the date of randomization to the death caused by any cause
Time frame: an expected average of 5 years
dverse events (AEs) were graded according to the NCI CTCAE version 5·0
Adverse events and surgical safety
Time frame: an expected average of 1.5 years
Tao Zhang, MD
CONTACT
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