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

November 13, 2019 updated by: Yulong Zheng, First Affiliated Hospital of Zhejiang University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • Department of Medical Onocology, First Affiliated Hospital of Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm A
Toripalimab 240mg IV, every 3 weeks;
Drug: Toripalimab
Toripalimab Injection
EXPERIMENTAL: Arm B
Toripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Drug: Paclitaxel
Paclitaxel Injection
Drug: Toripalimab
Toripalimab Injection
Drug: Carboplatin
Carboplatin Injection
EXPERIMENTAL: 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
Drug: Paclitaxel
Paclitaxel Injection
Drug: Cisplatin
Cisplatin injection
Drug: Toripalimab
Toripalimab Injection
Drug: 5-fu
5-fu injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MPR
Time Frame: 6 weeks
major pathologic response
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 months
progression free survival
6 months
AE
Time Frame: 2 years
adverse events
2 years
RFS
Time Frame: 2 years
recurrence free survival
2 years
ORR
Time Frame: 6 weeks
overall response rate
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Zhejiang University

Investigators

  • Study Chair: Nong Xu, MD, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 7, 2019

Primary Completion (ANTICIPATED)

November 7, 2020

Study Completion (ANTICIPATED)

November 7, 2021

Study Registration Dates

First Submitted

November 11, 2019

First Submitted That Met QC Criteria

November 13, 2019

First Posted (ACTUAL)

November 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 15, 2019

Last Update Submitted That Met QC Criteria

November 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJU20191451

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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