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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164238
• Other study ID #: ZJU20191451
• Status: Recruiting
• Phase: Phase 2
• Start date: November 7, 2019
• Est. completion date: November 7, 2021

Study information

• Verified date: November 2019
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Yulong Zheng, MD
• Phone: 13588166206
• Email: drzhengyu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: November 7, 2021
• Est. primary completion date: November 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• Toripalimab
Toripalimab Injection
• Paclitaxel
Paclitaxel Injection
• Carboplatin
Carboplatin Injection
• Cisplatin
Cisplatin injection
• 5-fu
5-fu injection

Locations

Country	Name	City	State
China	Department of Medical Onocology, First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MPR	major pathologic response	6 weeks
Secondary	AE	adverse events	2 years
Secondary	RFS	recurrence free survival	2 years
Secondary	ORR	overall response rate	6 weeks
Secondary	PFS	progression free survival	6 months