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

Zhejiang University

Status and phase: Unknown; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: Paclitaxel; Drug: Cisplatin; Drug: 5-fu; Drug: Carboplatin; Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04164238

ZJU20191451

Details and patient eligibility

About

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).

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

Arm A

Experimental group

Description:

Toripalimab 240mg IV, every 3 weeks;

Treatment:

Drug: Toripalimab

Arm B

Experimental group

Description:

Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m\^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W

Treatment:

Drug: Carboplatin

Drug: Paclitaxel

Drug: Toripalimab

Arm C

Experimental group

Description:

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

Treatment:

Drug: Cisplatin

Drug: 5-fu

Drug: Paclitaxel

Drug: Toripalimab