This study is a prospective phase II clinical trial aimed at exploring the potential benefits of supplementing β-hydroxybutyrate with existing short course radiotherapy sequential immunotherapy and CAPEOX therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Eligible subjects will receive short-course radiotherapy (SCRT). One week after the end of treatment, subjects continued to receive neoadjuvant chemotherapy.
1000mg/m2, bid, po, d1-14,q3w
130mg/m2, ivgtt, d1,q3w
The surgery was performed 1 week after the end of neoadjuvant therapy.
Oral β-hydroxybutyrate supplement (5g/day, starting from the day of first radiotherapy, lasting for 2 weeks).
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 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
Adverse 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
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