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To compare the efficacy of Neoadjuvant Chemoradiotherapy Combined With/without Tislelizumab in the Treatment of Locally Advanced Rectal Cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short-range radiotherapy sequential Tislelizumab combined with chemotherapy | Experimental |
| |
| short-range radiotherapy combined with chemotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab | Drug | Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 6 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response rate | Pathological examination of resected tissue samples revealed no residual tumor cells. | 4 weeks after surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response rate | The percentage of active tumor cells in excised tissue samples was less than 10% | 4 weeks after surgery |
| overall survival | Defined from date of Signing ICF to date of first documentation of death from any cause or censored at the date of the last follow-up. |
Inclusion Criteria:
Exclusion Criteria:
A) any surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy for the tumor; B) being treated with an immunosuppressive drug or systemic hormone for immunosuppression purposes within 2 weeks prior to initial use of the study drug (dose >10mg/ day of prednisone or equivalent);In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at doses >10mg/ d of prednisone or equivalent are permitted; C) received live attenuated vaccine within 4 weeks prior to initial use of the study drug; D) major surgery or severe trauma within 4 weeks prior to first use of the study drug;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Chun kang, Doctor of Medicine | Contact | 13509333116 | 86 | chuck330@163.com |
| Wu Jun xin, Doctor of Medicine | Contact | 13635293859 | 86 | junxinwu@126.com |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D000069287 | Capecitabine |
| D000077150 | Oxaliplatin |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Capecitabine | Drug | Participants will receive Capecitabine, 1000mg/m2, day 1-14 of every 3 weeks for 6 cycles |
|
| oxaliplatin | Drug | Participants will receive oxaliplatin, 130mg/m2, day 1 of every 3 weeks for 6 cycles. |
|
| short-range radiotherapy | Radiation | 5*5Gy,d1-d5 |
|
| every 3 months (up to 36 months) |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |