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

Phase 2

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Drug: Toripalimab; Drug: Paclitaxel; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-fu

• Registration Number: NCT04164238
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-07
• Study First Submitted: 2019-11-11
• Study First Submitted QC: 2019-11-13
• Last Update Submitted: 2019-11-13
• Study First Posted: 2019-11-15
• Last Update Posted: 2019-11-15
• Primary Completion: 2020-11-07
• Study Completion: 2021-11-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm C	Paclitaxel	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
Arm A	Toripalimab	Toripalimab 240mg IV, every 3 weeks;
Arm B	Toripalimab	Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Arm B	Paclitaxel	Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Arm B	Carboplatin	Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Arm C	Toripalimab	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
Arm C	Cisplatin	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
Arm C	5-fu	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

Primary Outcome Measures

Name	Time	Method
MPR	6 weeks	major pathologic response

Secondary Outcome Measures

Name	Time	Method
RFS	2 years	recurrence free survival
PFS	6 months	progression free survival
ORR	6 weeks	overall response rate
AE	2 years	adverse events

Trial Locations

Locations (1)

Department of Medical Onocology, First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China