Phase II Trial of Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in Head and Neck Squamous Cell Carcinoma Patients
Overview
- Phase
- Phase 2
- Intervention
- Toripalimab
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Sponsor
- First Affiliated Hospital of Zhejiang University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- MPR
- Last Updated
- 6 years ago
Overview
Brief Summary
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).
Investigators
Yulong Zheng
Principal Investigator
First Affiliated Hospital of Zhejiang University
Eligibility Criteria
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;
Arms & Interventions
Arm A
Toripalimab 240mg IV, every 3 weeks;
Intervention: Toripalimab
Arm B
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Intervention: Toripalimab
Arm B
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Intervention: Paclitaxel
Arm B
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Intervention: Carboplatin
Arm C
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
Intervention: Toripalimab
Arm C
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
Intervention: Paclitaxel
Arm C
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
Intervention: Cisplatin
Arm C
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
Intervention: 5-fu
Outcomes
Primary Outcomes
MPR
Time Frame: 6 weeks
major pathologic response
Secondary Outcomes
- RFS(2 years)
- PFS(6 months)
- AE(2 years)
- ORR(6 weeks)