search
Back to results

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

Primary Purpose

Head and Neck Squamous Cell Carcinoma

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Toripalimab
Paclitaxel
Carboplatin
Cisplatin
5-fu
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Squamous Cell Carcinoma focused on measuring HNSCC, PD-1 antibody, Neoadjuvant, Major pathologic response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • Department of Medical Onocology, First Affiliated Hospital of Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm A

Arm B

Arm C

Arm Description

Toripalimab 240mg IV, every 3 weeks;

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

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

Outcomes

Primary Outcome Measures

MPR
major pathologic response

Secondary Outcome Measures

AE
adverse events
RFS
recurrence free survival
ORR
overall response rate
PFS
progression free survival

Full Information

First Posted
November 11, 2019
Last Updated
November 13, 2019
Sponsor
First Affiliated Hospital of Zhejiang University
search

1. Study Identification

Unique Protocol Identification Number
NCT04164238
Brief Title
Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in HNSCC Patients
Official Title
Phase II Trial of Neoadjuvant Anti-PD-1 Antibody (Toripalimab) or Combined With Chemotherapy in Head and Neck Squamous Cell Carcinoma Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 7, 2019 (Actual)
Primary Completion Date
November 7, 2020 (Anticipated)
Study Completion Date
November 7, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Affiliated Hospital of Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
Keywords
HNSCC, PD-1 antibody, Neoadjuvant, Major pathologic response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Toripalimab 240mg IV, every 3 weeks;
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Arm Title
Arm C
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Intervention Description
Toripalimab Injection
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel Injection
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin Injection
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
Cisplatin injection
Intervention Type
Drug
Intervention Name(s)
5-fu
Intervention Description
5-fu injection
Primary Outcome Measure Information:
Title
MPR
Description
major pathologic response
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
AE
Description
adverse events
Time Frame
2 years
Title
RFS
Description
recurrence free survival
Time Frame
2 years
Title
ORR
Description
overall response rate
Time Frame
6 weeks
Title
PFS
Description
progression free survival
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yulong Zheng, MD
Phone
13588166206
Email
drzhengyu@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nong Xu, MD
Organizational Affiliation
Zhejiang University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Medical Onocology, First Affiliated Hospital of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CHENG XIAO, MD
Phone
87235896
Email
21218159@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs