There have been many high-quality research publications, including the TNT model of short-term radiotherapy combined with consolidation chemotherapy, and the TNT model of three-drug combination with neoadjuvant chemotherapy with higher treatment intensity combined with CRT. All have achieved better tumor regression and tumor regression than the standard CRT model. The higher pCR rate reduces the recurrence and metastasis events, improves the prognosis, and strives for more opportunities for organ function preservation. Can the TNT model combined with immunotherapy further increase the cCR rate? Whether immunotherapy can bring further survival benefits to patients who develop CR after neoadjuvant therapy (especially W\&W after cCR), it is also necessary to carry out corresponding clinical research. We designed this study for patients with mid-to-low and locally advanced rectal cancer who want to be able to preserve the anus. TNT mode combined with PD-1 immunotherapy is given before surgery, and TME surgery is performed on patients who have not reached cCR or who still require surgery. It provides sufficient evidence for the safety and effectiveness of preoperative neoadjuvant therapy for PD-1 in low- and middle-level locally advanced rectal cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Sintilimab combined withTotal Neoadjuvant Treatment
First Hospital of Jilin University
Changchun, Jilin, China
The incidence of serious adverse events
Any treatment-related grade 3 or higher non-hematological adverse event determined by CTCAE version v 4.03.
Time frame: 1 year
Complete response rate (CR)
defined as cCR or pCR achieved after neoadjuvant therapy.
Time frame: one week after Last medication
Neoadjuvant colorectal cancer (NAR) score
NAR score is a continuous scale with 24 possible discrete scores, ranging from 0 to 100. In this patient cohort, low scores were defined as \<8, median values were 8-16, and high scores were\> 16, and the corresponding 5-year OS was 92%, 89%, and 68%, respectively. A higher score is associated with a worse prognosis.
Time frame: One week after the surgery
Tumor downgrading rate
the rate of downgrading confirmed by MRI
Time frame: One week after surgery
3-year non-local regeneration disease-free survival (NR-DFS)
It is defined as the time of death, local recurrence after radical resection, and any form of distant metastasis within 3 years from the date of receiving neoadjuvant therapy. The local regeneration of the tumor that can be rescued after non-surgical treatment is not regarded as a local recurrence, nor is it counted as a positive event.
Time frame: 3 years from the date of receiving neoadjuvant therapy
3 years disease-free survival
3 years disease-free survival
Time frame: 3 years from the date of receiving neoadjuvant therapy
5 years disease-free survival
5 years disease-free survival
Time frame: 5 years from the date of receiving neoadjuvant therapy
3-year local recurrence rate
3-year local recurrence rate
Time frame: 3 years from the date of receiving neoadjuvant therapy
3 years overall survival
3 years overall survival
Time frame: 3 years from the date of receiving neoadjuvant therapy
5 years overall survival
5 years overall survival
Time frame: 5 years from the date of receiving neoadjuvant therapy
QLQ-C30 score
QLQ-C30(Quality of Life Questionnaire C30)
Time frame: up to 12 months
QLQ-C29
QLQ-C29(Quality of Life Questionnaire C29)
Time frame: up to 12 months
Low Anterior Resection Syndrome
LARS score(Low Anterior Resection Syndrome Questionnaire)
Time frame: up to 12 months
IPSS score
IPSS score(International Prostate Symptom Score)
Time frame: up to 12 months
CIPE score
CIPE (Chinese Index of sexual Function for premature Evaluation,CIPE)score
Time frame: up to 12 months
Quality of life and function assessment
IIEF-5(international questionnaire of erectile function-5)score
Time frame: up to 12 months
FEFSI-6 score
FEFSI-6 score
Time frame: up to 12 months
Wexner score
Wexner incontinence score
Time frame: up to 12 months
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