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Head and Neck Squamous Cell CarcinomaPhase 2NCT04164238

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

A Phase 2 study testing Toripalimab, Paclitaxel and Carboplatin in people with Head and Neck Squamous Cell Carcinoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Toripalimab, Paclitaxel and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
7 Nov 2019to 7 Nov 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;

Who cannot join

  • Distant metastasis;
  • Second malignancy within 5 years;
  • Nasopharyngeal carcinoma;
  • Active autoimmune diseases;
  • HIV infected;
  • Required prednisone dose >=10mg daily;
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  • Heart attack within 6 months;
  • Stroke within 6 months;
  • Other conditions that investigators consider the patients are not suitable for PD-1antibody;

Trial locations and contacts

1 site in 1 country.

Yulong Zheng, MD contact

13588166206

drzhengyu@126.com

China1 site, 1 recruiting

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

    Hangzhou, Zhejiang, 310003

    CHENG XIAO, MD, 87235896, 21218159@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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).

Keywords
HNSCC, PD-1 antibody, Neoadjuvant, Major pathologic response
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04164238
Study groupRoleWhat they receive
Arm AExperimentalToripalimab 240mg IV, every 3 weeks;
Receives: Drug: Toripalimab
Arm BExperimentalToripalimab 240mg IV, Q3W; Paclitaxel 175mg/m^2, IV, Q3W; Carboplatin AUC 5, IV, Q3W
Receives: Drug: Toripalimab; Drug: Paclitaxel; Drug: Carboplatin
Arm CExperimentalToripalimab 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
Receives: Drug: Toripalimab; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5-fu

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MPR

    major pathologic response

    Measured: 6 weeks

Secondary outcomes (4)

  1. AE

    adverse events

    Measured: 2 years

  2. RFS

    recurrence free survival

    Measured: 2 years

  3. ORR

    overall response rate

    Measured: 6 weeks

  4. PFS

    progression free survival

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2019
  2. Study start7 Nov 2019
  3. Primary completion7 Nov 2020 (estimated)
  4. Study completion7 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04164238
Sponsor's protocol ID
ZJU20191451
Status last verified
Nov 2019
First submitted
11 Nov 2019
Last updated
15 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab, Paclitaxel and Carboplatin in people with Head and Neck Squamous Cell Carcinoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yulong Zheng, MD (13588166206, drzhengyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MPR (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04164238.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2019.

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