Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients

Study Overview
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Brief Summary
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This study evaluate either Toripalimab or combined with chemotherapy as neoadjuvant treatment for patients with head and neck squamous cell carcinoma. Participants in arm A receive Toripalimab, in arm B receive Toripalimab plus PC (paclitaxel and carboplatin), arm C with Toripalimab plus modified TPF(paclitaxel and cisplatin and 5-fu).

Official Title
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Phase II Trial of Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in Head and Neck Squamous Cell Carcinoma Patients

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Toripalimab
* Drug: Paclitaxel
* Drug: Carboplatin
* Drug: Cisplatin
* Drug: 5-fu


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed pathologic or cytologic diagnosis of squamous cell carcinoma of head and neck; Resectable or potentially resectable lesion; ECOG PS 0-1; Age >18 years old; At least one target lesion according to RECIST 1.1; Proper function of the cardiovascular system, liver, kidney and bone marrow for receiving chemotherapy and surgery; Exclusion Criteria: Distant metastasis; Second malignancy within 5 years; Nasopharyngeal carcinoma; Active autoimmune diseases; HIV infected; Required prednisone dose >=10mg daily; Heart attack within 6 months; Stroke within 6 months; Other conditions that investigators consider the patients are not suitable for PD-1antibody;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A<br>Toripalimab 240mg IV, every 3 weeks; | Drug: Toripalimab<br>* Toripalimab Injection<br>|
| Experimental: Arm B<br>Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W | Drug: Toripalimab<br>* Toripalimab Injection<br>Drug: Paclitaxel<br>* Paclitaxel Injection<br>Drug: Carboplatin<br>* Carboplatin Injection<br>|
| Experimental: Arm C<br>Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Cisplatin 25mg/m^2 IV,d1-d3, Q3W; 5-FU 3000mg/m^2 CIV 72h, Q3W | Drug: Toripalimab<br>* Toripalimab Injection<br>Drug: Paclitaxel<br>* Paclitaxel Injection<br>Drug: Cisplatin<br>* Cisplatin injection<br>Drug: 5-fu<br>* 5-fu injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPR | major pathologic response | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE | adverse events | 2 years | 
| RFS | recurrence free survival | 2 years | 
| ORR | overall response rate | 6 weeks | 
| PFS | progression free survival | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HNSCC, PD-1 antibody, Neoadjuvant, Major pathologic response