Short-course radiotherapy combined with immunotherapy may bring revolutionary changes to the preoperative neoadjuvant treatment mode for locally advanced rectal cancer. According to the existing theory, the use of PD-L1 monoclonal antibody after short-course radiotherapy may be the best solution. In this study, the investigators will perform single-cell sequencing of participants tissue samples, fully explore the multi-dimensional omics information of tumors and microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
This product is administered by subcutaneous injection. The recommended dose of subcutaneous injection is 150 mg, administered weekly (QW).
130mg/m2,ivgtt,d1
1000mg/m2,po,bid,d1-14
Short-course radiotherapy, using three-dimensional conformal or intensity-modulated radiotherapy, the dose is divided into 5Gy/f, the total dose is 25Gy/5f, 1f/d, and the irradiation is completed within 7 days.
The surgical method can choose open, laparoscopic or robotic according to the specific condition of the patient.
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The primary objective of the study is to evaluate the pathologic complete response (pCR) rate following short-course radiation then Envafolimab Plus CAPEOX
pCR was defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0).
Time frame: Up to 10 weeks (once surgery is done)
Tumor regression grade following short-course radiation then Envafolimab Plus CAPEOX as assessed by AJCC/CAP TRG system
Tumor Regression Grade(TRG)will be done via pathologic assessment on the surgical specimen with AJCC/CAP TRG system
Time frame: Up to 10 weeks (once surgery is done)
The proportion of participants who remain survival at 3 years
Defined as the percentage of patients alive after 3-year follow-up
Time frame: Up to 3 years
The proportion of participants who remain progression free at 3 years
Defined as the percentage of patients without disease recurrence or progression after 3-year follow-up
Time frame: Up to 3 years
Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0
Treatment- related adverse events are assessed by NCI-CTCAE v5.0 in each visit
Time frame: Up to 3 years
Surgical Complications of total mesorectal resection procedure for patients after short-course radiation then Envafolimab Plus CAPEOX as assessed by Clavien-Dindo classification
Surgical Complications are assessed by Clavien-Dindo classification after surgery.
Time frame: Up to 24 weeks
Quality of life of the patients in a neoadjuvant setting of short-course radiation then Envafolimab Plus CAPEOX as assessed by FACT-C questionnaire
Quality of life is measured via FACT-C questionnaire in each visit.
Time frame: Up to 3 years
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