Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer.In view of the shortcomings of the current preoperative neoadjuvant treatment model for locally advanced rectal cancer, we will explore the feasibility of a new model of short-course radiotherapy combined with immunotherapy, and develop a possible optimal plan based on the existing theoretical basis, namely "short-course radiotherapy + PD-L1 monoclonal antibody combined with CAPEOX chemotherapy for 2 cycles", and explore the efficacy and adverse effects of this model. The study will also attempt to explore the characteristics of the treatment beneficiary population, explore the characteristics of the treatment beneficiary population by multi-dimensional tumor and microenvironmental information through multi-omics sequencing analysis, attempt to build an efficacy prediction model, early screening of the treatment beneficiary population for precise treatment, and thus explore a new model of radiotherapy combined with immunotherapy.
Patients who are willing to receive neoadjuvant therapy.
≧18 years old.
Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 12 cm from the anus.
Histologically diagnosed as rectal adenocarcinoma.
History of other malignant diseases in the past 5 years.
Patients with metastases from other sites (stage IV patients).
Patients with clinical staging of T1-2N0 or T4b, or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.
Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
Parallel
Envafolimab
Biological/VaccineThis product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW).
pCR rate
The primary objective of the study is to evaluate the pathologic complete response (pCR) rate following short-course radiation then Envafolimab Plus CAPEOX
Tumor regression grade
Tumor regression grade following short-course radiation then Envafolimab Plus CAPEOX as assessed by AJCC/CAP TRG system
OS
The proportion of participants who remain survival at 3 years
PFS
The proportion of participants who remain progression free at 3 years
TRAEs
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
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