The combination of short course radiotherapy and immunotherapy helps to increase the proportion of pathological complete response after neoadjuvant therapy, providing more patients with the opportunity for organ preservation. However, there is no accurate and unified cCR diagnostic standard in the world. As a new radiotracer, 18F-FAPI has been developed and used to target fibroblast activating protein and tumor matrix visualization, which has the advantages of low background uptake, high contrast, few preparation requirements, short post-injection interval, and no influence on blood glucose. Therefore, we will invite you to participate in a clinical study to explore whether the PET parameters of 18F-FDG and 18F-FAPI-42 PET/CT can be used to predict pathological responses after neoadjuvant therapy for locally advanced rectal cancer (LARC). The findings will help improve future treatment stratification of LARC, help patients preserve organs and improve quality of life.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
52
Patientsreceived neoadjuvant treatment consisting of SCRT (a total of 25 Gy in 5 days) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles) combined with CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 h on day 1, capecitabine 1000 mg/m2 orally twice daily from day 1-14, in every 3-week cycle for two cycles) 1 week later.
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Pathological complete response (pCR) prediction accuracy
PCR prediction accuracy was defined as the ratio at which 18F-FAPI-42 combined with 18F-FDG PET/CT predicted results in agreement with post-operative pathologic diagnoses.
Time frame: 3 months
Prediction accuracy of non-pathological complete response (npCR)
The prediction accuracy of nPCR was defined as the ratio at which 18F-FAPI-42 combined with 18F-FDG PET/CT and histopathological profiling predicted nPCR to be consistent with post-operative pathological diagnosis
Time frame: 3 months
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