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Head and neck cancer is the malignant tumor with the highest morbidity and mortality, of which 60% present with locally advanced disease at initial diagnosis, and the 5-year survival rate of standard treatment is less than 30%. Standard of care (SOC) including adjuvant and neoadjuvant therapy can provides only about 5-10% clinical benefit. According to the available data on the application of immunotherapy as adjuvant therapy in operable patients, adjuvant immunotherapy is safe and feasible, with a significant trend of benefit. Based on the above positive and meaningful clinical needs and scientific basis, it is very necessary to carry out clinical trials of adjuvant immunotherapy. The primary objective of this study is to evaluate the efficacy and safety of immune maintenance therapy in patients with locally advanced head and neck squamous cell carcinoma who achieve MPR after neoadjuvant immunotherapy combined with chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toripalimab | Experimental | toripalimab, IV, 240mg, q3w, for 15 cycles |
|
| SOC CCRT or radiotherapy | Active Comparator | Standard concurrent radiochemotherapy or postoperative radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Toripamab, IV, 240mg, every 3 weeks for 15 cycles |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Free Survival | defined as the time from random assignment to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first. | up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Over survival (OS) | OS is defined as the time from randomization to death due to any cause or censored at the date of last follow-up. | up to 4 years |
| Toxicity Adverse events | Grade 1-5 AEs according to NCI-CTCAE V5.0 |
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Inclusion Criteria:
Absolute neutrophil count ≥ 1.5 × 10^9/L, hemoglobin ≥ 9.0g/dL, platelets ≥100000/μL; ALT and AST < 2.5× upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN; Creatinine clearance ≥ 60 ml/min; APTT≤ 1.5×ULN.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xudong Wang, Dr. | Contact | +862223340123 | 3130 | wxd.1133@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| Radiation Therapy |
| Radiation |
Radiation Therapy |
|
| Cisplatin | Drug | Chemotherapy agent |
|
| up to 1 year |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
| D011878 | Radiotherapy |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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