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After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.
After signing the informed consent form, patients who met the inclusion and exclusion criteria were given the full course of neoadjuvant treatment: short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC48 group | Experimental | short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disitamab vedotin, sintilimab, capecitabine | Drug | short-term radiotherapy, followed by 6 consecutive cycles of disitamab vedotin, combined with sintilimab and capecitabine, and within 3-4 weeks after the last dose, they underwent preoperative imaging examinations to evaluate the efficacy of the neoadjuvant treatment and the possibility of total mesorectal excision. Whether adjuvant therapy was performed after surgery was determined by the investigators. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response (CR) rate | The primary end point was CR rate, which was calculated by dividing the number of patients with a pCR for those who underwent surgery and a cCR for those who underwent WW by the total number of evaluable patients. The pCR was defined as the absence of any tumor cells from the primary tumor and lymph nodes in the specimen after radical surgery (ypT0N0) or the absence of any tumor cells in the lesion after local resection (ypT0). The cCR was defined as the absence of residual disease on DRE, MRI, and endoscopy. | Perioperative |
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Inclusion Criteria:
1) CT stage cT4a or cT4b 2) Extramural vascular invasion (EMVI+) 3) Clinical lymph node (CN) stage cN2, involving the mesenteric fascia 3)Positive lateral lymph nodes 5. Subjects have not previously received systematic treatment for the current disease, including anti - tumor radiotherapy, chemotherapy, immunotherapy, etc.
6. IHC results confirm HER2 expression (defined as IHC 1+, 2+, 3+). 7. The ECOG score is 0 - 1. 8. The estimated survival time is ≥6 months. 9. The functions of major organs are good, meeting the following criteria: 10. In the blood routine examination (without blood transfusion and without using hematopoietic stimulating factors to correct the state within 14 days): Hemoglobin (Hb) ≥90 g/L; Absolute neutrophil count (ANC) ≥1.5×10⁹/L; Platelet (PLT) ≥80×10⁹/L.
11. In the biochemical examination: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; Total serum bilirubin (TBIL) ≤1.5×ULN; Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate ≥60 mL/min.
12. In terms of coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤1.5×ULN.
13. According to Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF) ≥50%.
14. The doctor clinically determines that the subject has sufficient organ function.
15. Subjects of child - bearing potential must use appropriate contraceptive methods during the study and within 120 days after the study ends. The serum pregnancy test should be negative within 7 days before study enrollment, and the subjects must not be lactating.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhenyu Lin | Contact | 15827130893 | whxhlzy@hust.edu.cn |
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|
| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| C000722994 | disitamab vedotin |
| C000632826 | sintilimab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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