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This study compares two short pre-surgery treatments for locally advanced head and neck squamous cell cancer to see which one keeps the cancer from coming back longer.
Eligible patients (18-70 years, newly diagnosed, operable) will be randomly assigned to receive either toripalimab (immunotherapy) alone or toripalimab plus two cycles of chemotherapy (docetaxel and cisplatin). After the two cycles, all patients will have standard surgery followed by radiation (or chemo-radiation).
We will track tumor response, side effects, and quality of life. Possible benefits: tumor shrinkage and lower chance of recurrence; possible risks: low blood counts, rash, tiredness, or other drug-related side effects.
Taking part is voluntary and you can leave the study at any time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab monotherapy | Experimental | Participants receive two 3-week cycles of toripalimab 240 mg IV before undergoing radical surgery, followed by post-operative radiotherapy or chemoradiotherapy plus 12 additional cycles of toripalimab. |
|
| Toripalimab + chemotherapy | Experimental | Participants receive two 3-week cycles of toripalimab 240 mg IV combined with docetaxel 75 mg/m² and cisplatin 75 mg/m² before radical surgery, followed by post-operative radiotherapy or chemoradiotherapy plus 12 additional cycles of toripalimab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docetaxel and Cisplatin | Drug | Neoadjuvant chemotherapy: docetaxel 75 mg/m² IV Day 1 + cisplatin 75 mg/m² IV Day 1, repeated every 21 days for 2 cycles, given together with toripalimab in the combination arm. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year Event-Free Survival | Proportion of patients alive and free from locoregional recurrence, distant metastasis, second primary tumor, or death from any cause within 24 months after randomisation, assessed per modified RECIST 1.1. | From randomisation to 24 months |
| 2-year Event-Free Survival (EFS) | Proportion of patients alive and free from locoregional recurrence, distant metastasis, second primary tumor, or death from any cause within 24 months after randomisation, assessed per modified RECIST 1.1. | From randomisation to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuekui Liu, MD, PhD | Contact | :020-87343009 | liuxuek@sysucc.org.cn |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| C000656314 | toripalimab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
| Toripalimab | Drug | Humanised anti-PD-1 IgG4κ monoclonal antibody. 240 mg IV infusion Day 1 of each 21-day cycle for 2 neoadjuvant cycles, then 3 cycles concurrent with post-op radiotherapy/chemoradiotherapy, followed by 12 adjuvant cycles every 3 weeks. |
|
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |