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We expect to conduct a clinical trial in high-risk locally advanced nasopharyngeal carcinoma patients to explore the efficacy and safety of sequential radical radiotherapy treatment after induction chemotherapy (TPC vs. GP) with combination therapy of nivolumab and triprolizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TPC+Triprolizumab+Nimotuzumab | Experimental |
| |
| GP+Triprolizumab+Nimotuzumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab,Toripalimab,Cisplatin, albumin paclitaxel, capecitabine | Drug | Albumin paclitaxel 200g/m2, intravenous drip administration, d1; Cisplatin 60 mg/m2, Intravenous , d1; Capecitabine, 1000mg/m2, orally administered D1-14; Triprolizumab injection 240mg, intravenous D1; Nivolumab 400mg, intravenous D1; Q3W 1 cycle, 3 cycles Period, 3 weeks in total |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year event free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| adverse effects | chemotherapy side effectst | 3 years |
| 3-year overall survival | 3 years | |
| 3-year distant disease free survival |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Nimotuzumab,Toripalimab,Cisplatin, Gemcitabine | Drug | Cisplatin 80 mg/m2, Intravenous drip administration, d1; Gemcitabine, 1000mg/m2,Intravenous ,D1,D8; Triprolizumab injection 240mg, intravenous ; Nivolumab 400mg, intravenous; Q3W 1 cycle, 3 cycles |
|
| 3 years |
| 3-year local recurrence free survival rate | 3 years |
| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| 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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