AzTrials
AzTrials

Locally Advanced Head and Neck Squamous Cell CarcinomaPhase 2NCT05773079

Toripalimab Maintenance for Locally Advanced Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing Toripalimab in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial summary

The guidelines for locally advanced head and neck squamous cell carcinoma currently recommend surgery / radiotherapy / chemotherapy / targeted therapy. However, the median PFS of patients with high risk factors after comprehensive treatment was about 17 months, and the 2-year PFS rate was about 40 %. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
No sites listed yet
Study dates
May 2024to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced squamous cell carcinoma of the head and neck (AJCC8thIII-IV) confirmed by pathology in the initial treatment;
  • No residual lesions after first-line surgery/radiotherapy/chemotherapy/targeted comprehensive treatment;
  • Associated high risk factors: T3-4, regional lymph node positive, vascular invasion, neural invasion, lymph node capsular invasion, incisional margin positive;
  • The patients' age is between 18 and 70 years old;
  • The ECOG physical fitness status score is 0 or 1;
  • Estimated survival period ≥ 3 months;
Show all 10Show fewer
  • The main organ functions meet the following standards: (1) Blood routine (without blood transfusion within 14 days): HGB ≥ 110g /L, WBC ≥ 3.0 × 10^9\/L， NEUT≥1.5 × 10^9\/L，PLT ≥75 × 10^9\/L； (2) Biochemical: BIL ≤ 1.5 times the upper limit of normal value (ULN), ALT and AST ≤ 2.0 × ULN, serum Cr ≤ 1.5 × ULN or endogenous creatinine clearance ≥ 50ml /min; (3) Occult blood in stool (-); (4) Normal urine routine, or urine protein\<(++), or 24-hour urine protein\<1.0g; (5) Left ventricular ejection fraction (LVEF) ≥ 50%. (6) The blood coagulation function is normal, and there is no active bleeding or thrombosis disease. A. International standardized ratio INR ≤ 1.5 × ULN； B. Partial thromboplastin time APTT ≤ 1.5 × ULN； C. Prothrombin time PT ≤ 1.5ULN. (7) Thyroid stimulating hormone (TSH) ≤ 1.5ULN; If the T3 and T4 levels are abnormal, they should be investigated. If the T3 and T4 levels are normal, they can be selected;
  • Women of childbearing age should agree to use contraceptives (such as intrauterine devices, birth control pills, or condoms) during and within 3 months after the end of medication; "Within 7 days prior to study enrollment, the serum or urine pregnancy test was negative and must be a non lactating patient. The male should agree to use contraception during the study period and within 3 months after the end of the study period;
  • Patients with hepatitis B virus (HBV) infection, inactive/asymptomatic HBV carriers, or patients with chronic or active HBV who received antiviral therapy for\>1 week at the time of screening are allowed to be enrolled and continue treatment for more than 6 months after the study drug treatment. Patients with positive hepatitis C antibodies who have started anti hepatitis C virus treatment at the time of screening will be allowed to participate in the group;
  • Subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Who cannot join

  • Distant metastasis of the tumor was detected upon enrollment;
  • Have a history of allergy to PD-1 monoclonal antibody or drug components;
  • There has been a history of other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary carcinoma;
  • Uncontrolled clinical cardiac symptoms or diseases, such as: (1) heart failure above NYHA class II; (2) unstable angina; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
  • Have received any of the following treatments: a. Have previously received treatment with immunosuppressive drugs; B. Have received any investigational drug within 4 weeks before the first use of the investigational drug; C. Joining another clinical study at the same time, unless it is an observational (non intervention) clinical study or an intervention clinical study follow-up; D. Subjects who require systemic treatment with corticosteroids (greater than 10 mg prednisone equivalent dose per day) or other immunosuppressants within 2 weeks prior to the first use of the study drug, excluding the use of corticosteroids for local inflammation and the prevention of allergies, nausea, and vomiting. In the absence of active autoimmune diseases, it is allowed to inhale or locally use steroids and adrenal cortical hormone replacement with a dose greater than 10 mg/day of prednisone; E. Have received an anti-tumor vaccine or a live vaccine within 4 weeks before the first administration of the study drug; F. Major surgery or severe trauma requiring removal of the disease within 4 weeks before the first use of the study drug;
  • Serious infections (CTCAE greater than Level 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, intracranial infection, etc. that require hospitalization;
Show all 16Show fewer
  • Have a history of active autoimmune diseases and autoimmune diseases, but does not include autoimmune mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes with a stable dose of insulin; Patients with vitiligo or recovered childhood asthma/allergies who do not require any intervention in adulthood;
  • Have a history of immunodeficiency, including HIV testing positive, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation and bone marrow transplantation;
  • Have a history of interstitial lung disease and non infectious pneumonia;
  • Patients who have a history of active pulmonary tuberculosis infection through medical history or CT examination, or who have a history of active pulmonary tuberculosis infection within 1 year before enrollment, or who have a history of active pulmonary tuberculosis infection before 1 year but have not received formal treatment;
  • Subjects with active hepatitis (HBV DNA ≥ 2000 IU /ml or 10000 copies /ml) who have not been treated, and hepatitis C (hepatitis C antibody positive, and HCV-RNA above the detection limit of the analytical method) who have not been treated;
  • Known history of abuse, alcoholism, and drug abuse of psychotropic substances;
  • KPS score<60, intolerance to anti-tumor therapy;
  • Pregnant or lactating women;
  • Engaging or expected to participate in other clinical studies;
  • Researchers believe that it is not suitable for inclusion.

About this study

Official title: Toripalimab Maintenance After First-line Comprehensive Therapy for Locally Advanced Head and Neck Squamous Cell Carcinoma: a Single-arm, Phase II Study

The guidelines for locally advanced head and neck squamous cell carcinoma currently recommend surgery / radiotherapy / chemotherapy / targeted therapy. However, the median PFS of patients with high risk factors after comprehensive treatment was about 17 months, and the 2-year PFS rate was about 40 %. The KEYNOTE-048 study showed that PD-1 monoclonal antibody alone or in combination with chemotherapy significantly improved survival and was safe for recurrent / metastatic head and neck squamous cell carcinoma. Therefore, PD-1 monoclonal antibody has become the first-line treatment of metastatic head and neck squamous cell carcinoma. For locally advanced head and neck squamous cell carcinoma, the existing studies on immunotherapy for neoadjuvant or concurrent chemoradiotherapy have not been clearly concluded. We previously used PD-1 monoclonal antibody for the maintenance treatment of patients after the first-line treatment of locally advanced head and neck squamous cell carcinoma, without residual tumor, which showed a trend of prolonged survival. Therefore, this study intends to explore whether the maintenance treatment of PD-1 monoclonal antibody terripril can further improve the survival of patients with locally advanced head and neck squamous cell carcinoma with high risk factors and no residual tumor after first-line comprehensive treatment, and the safety is good.

Being tested
Toripalimab
Keywords
Squamous Cell Carcinoma of Head and Neck, Toripalimab, PFS, Immunotherapy
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.

  • ToripalimabDrug

    Within 4 to 12 weeks after the first line of treatment, the maintenance treatment of Toripalimab was started, and 240 mg of Toripalimab was injected intravenously every 3 weeks (the maintenance treatment time was not more than 1 year, until there was an intolerable toxic reaction, or disease progression, or withdrawal of consent, or the investigator judged that it was necessary to withdraw from the treatment, or the subject had received treprizumab treatment for a cumulative period of 1 year or other reasons specified in the protocol). During the treatment period, tumor imaging evaluation shall be conducted every 3 months to see the research process description for details, and the evaluation shall be conducted according to the evaluation criteria of recist. If the evaluation is progress, the treatment shall be stopped.

Study groups in NCT05773079
Study groupRoleWhat they receive
ToripalimabExperimentalToripalimab 240mg, VD, Q3W (treatment time: maintain for 1 year or until disease progression or intolerance requires drug withdrawal)
Receives: Drug: Toripalimab

What is being measured

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

  1. 2-year progression-free survival

    The time from the day of first-line systemic treatment to disease progression or death.

    Measured: 2 years

Secondary outcomes (1)

  1. 2-year Overall Survival

    The time from the day of first-line treatment to the death of any cause.

    Measured: 2 years

Timeline

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

  1. First posted17 Mar 2023
  2. Study startMay 2024 (estimated)
  3. Primary completionFeb 2026 (estimated)
  4. Study completionJun 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05773079
Sponsor's protocol ID
NFEC-2022-371
Status last verified
Mar 2024
First submitted
6 Mar 2023
Last updated
1 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab in people with Locally Advanced Head and Neck Squamous Cell Carcinoma, run by Nanfang Hospital, Southern Medical University.

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 10 inclusion and 16 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: opening soon, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2-year progression-free survival (time frame: 2 years). 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 NCT05773079.

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 1 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in