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This is a single-center, multidisciplinary, open-label, single-arm prospective clinical study.
In this study, 51 patients with hypohparyngeal carcinoma will be enrolled, These patients who have locally advanced-stage disease, including TNM stage cT3-4aN0-2M0 (AJCC 7th) and require a total laryngectomy as an initial therapy. Patients who achieved a CR or PR at the primary site after three cycles of TPF-regimen chemotherapy combined with immuotherapy will be referred for definitive RT and immuotherapy, while patients who received an evaluation of PD or SD at the primary site were referred for surgery followed by adjuvant RT/CRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab (PD-1 inhibitor) group | Experimental | Induction chemotherapy combined with immunotherapy (TPF + Camrelizumab), q3w, 3 cycles in total: Docetaxel (domestic) 75 mg/m2 i.v. d1, Cisplatin 25 mg/m2 i.v. d1-3, Capecitabine 800 mg/m2 po bid d1-d14, Camrelizumab 200mg i.v. d1; Radical radiotherapy plus concurrent immunotherapy (CR or PR): Radiotherapy: Using intensity-modulated radiation therapy (IMRT). Primary site: GTV dose 66 (2.2Gy / fraction)-70 Gy (2Gy / fraction);CTV 1.6-1.9 Gy / fraction. Cervical lymph nodes: Radiotherapy plan is the same as the radiotherapy plan of original site; Concurrent immunotherapy : Camrelizumab 200mg i.v. d1, d22; Maintenance period: After completing concurrent chemoradiotherapy combined with immunotherapy, Camrelizumab 200 mg q3w will be given up to 12 months (calculated from the time of the first dose of PD-1 immunotherapy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel | Drug | Docetaxel is a chemotherapy drug. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate | The proportion of patients with partial and complete response as defined by RECIST 1.1 after induction therapy | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LPR | Larynx preservation rate | 3 years |
| PFS | Progression free survival | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liang Zhou, PhD. | Eye & ENT Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye & ENT Hospital, Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| D007012 | Hypopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D000091502 | Home Environment |
| D002945 | Cisplatin |
| D000069287 | Capecitabine |
| C000631724 | camrelizumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Cisplatin | Drug | Cisplatin is a chemotherapy drug. |
|
|
| Capecitabine | Drug | Capecitabine is a chemotherapy drug. |
|
|
| Camrelizumab | Drug | Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody. |
|
|
| MFS | Metastasis free survival | 3 years |
| OS | Overall survival | 3 years |
| D009369 | Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D012111 | Residence Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D005191 | Family Characteristics |
| D012959 | Socioeconomic Factors |
| D004777 | Environment |
| D004778 | Environment and Public Health |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| 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 |