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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Total Neoadjuvant Treatment combined with Sintilimab | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | Sintilimab combined withTotal Neoadjuvant Treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of serious adverse events | Any treatment-related grade 3 or higher non-hematological adverse event determined by CTCAE version v 4.03. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate (CR) | defined as cCR or pCR achieved after neoadjuvant therapy. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| C000632826 | sintilimab |
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| One week after the surgery |
| Tumor downgrading rate | the rate of downgrading confirmed by MRI | 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. | 3 years from the date of receiving neoadjuvant therapy |
| 3 years disease-free survival | 3 years disease-free survival | 3 years from the date of receiving neoadjuvant therapy |
| 5 years disease-free survival | 5 years disease-free survival | 5 years from the date of receiving neoadjuvant therapy |
| 3-year local recurrence rate | 3-year local recurrence rate | 3 years from the date of receiving neoadjuvant therapy |
| 3 years overall survival | 3 years overall survival | 3 years from the date of receiving neoadjuvant therapy |
| 5 years overall survival | 5 years overall survival | 5 years from the date of receiving neoadjuvant therapy |
| QLQ-C30 score | QLQ-C30(Quality of Life Questionnaire C30) | up to 12 months |
| QLQ-C29 | QLQ-C29(Quality of Life Questionnaire C29) | up to 12 months |
| Low Anterior Resection Syndrome | LARS score(Low Anterior Resection Syndrome Questionnaire) | up to 12 months |
| IPSS score | IPSS score(International Prostate Symptom Score) | up to 12 months |
| CIPE score | CIPE (Chinese Index of sexual Function for premature Evaluation,CIPE)score | up to 12 months |
| Quality of life and function assessment | IIEF-5(international questionnaire of erectile function-5)score | up to 12 months |
| FEFSI-6 score | FEFSI-6 score | up to 12 months |
| Wexner score | Wexner incontinence score | up to 12 months |