A Single-center, Single-arm Phase II Clinical Study Based on FAPI-PET/CT Technology to Predict Pathological Complete Response After Neoadjuvant Chemoradiotherapy for MSS Rectal Cancer
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, 68Ga-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 68Ga-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.
• With my consent and signed informed consent, willing and able to comply with the planned visit, research treatment, laboratory tests and other test procedures;
• Age 18-75;
• Patients with a pathologically or cytologically confirmed adenocarcinoma of the rectum, all other histological types excluded;
• The distance between the lower margin of the rectal tumor lesion and the anal margin \<12cm;
• The physical status score (ECOG) of the Eastern United States Cancer Cooperative Group was 0-1 ;
• T3-4/N+ was evaluated by pelvic enhanced MRI;
• Had not received systemic anti-tumor therapy for colon cancer, including cytotoxic drugs, immune checkpoint inhibitor therapy, molecular targeted therapy, endocrine therapy, etc.;
• Appropriate organ function based on the following laboratory test values obtained during the screening period: White blood cell count ≥3×109/L, neutrophil count ≥1.5×109 /L, platelet count ≥75×109 /L, serum total bilirubin ≤ 1.5× upper limit of normal (UNL), AST (SGOT) or ALT (SGPT) ≤ 2.5×UNL, serum creatinine ≤ 1.5×UNL;
• Female subjects of reproductive age must undergo a negative serum pregnancy test within 3 days prior to the start of the study drug and be willing to use a medically approved highly effective contraceptive method (such as an IUD, contraceptive pill, or condom) during the study period and within 3 months after the last study drug administration; Male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use effective contraception during the study period and for 3 months after the last study dosing;
• Willing and able to comply with research procedures and visit plans.