The Effect of Nitozumab in the Treatment of Head and Neck Squamous Cell Carcinoma

April 16, 2023 updated by: Yangkun Luo, Sichuan Cancer Hospital and Research Institute

Radiotherapy Combined With Nitozumab and Sinilimab in the Treatment of Locally Advanced Unresectable Platinum Intolerant Head and Neck Squamous Cell Carcinoma： an Open-label Single-arm, Phase II Trial

For patients with locally advanced head and neck tumors who are over 70 years old, have PS>2, have hearing impairment, renal dysfunction, or have neuropathy greater than grade 1 that is intolerant to cisplatin, radiotherapy alone or combined with EGFR monoclonal antibody radiotherapy should be chosen. The purpose of this study is to demonstrate the superior efficacy of Nitozumab and Sinilimab when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Sichuan Cancer Hospital and Research Institute
        • Contact:

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

1.18 years old or above; 2.The subject is a newly diagnosed head and neck squamous cell carcinoma patient who has been confirmed by histopathology or cytology to have stage III-IVB head and neck squamous cell carcinoma (including oral cancer, oropharyngeal cancer, laryngeal cancer, and hypopharyngeal cancer); 3.Tumor tissue samples with positive or weakly positive EGFR immunohistochemistry or FISH detection, i.e. EGFR 2+and EGFR 3+; 4.Locally advanced patients who are not suitable for surgery (referring to patients whose physical conditions do not allow, who refuse surgery due to various reasons, or whose tumor load is too large to be removed), as well as patients with recurrence and metastasis; 5.CPS≥1 6.Absolute contraindications for the use of cisplatin: ECOG ≥ 3 points, creatinine clearance rate<50ml/min, previous hearing impairment or tinnitus ≥ grade 2, grade 2 neuropathy, allergies to drugs containing platinum or mannitol, cardiovascular and respiratory complications, pregnancy, lactation, HIV/AIDS: CD4 count<200/ μ l。 Relative contraindications not suitable for the use of cisplatin: ECOG=2, age>70 years old, creatinine clearance rate 50-60ml/min, previous hearing impairment or tinnitus ≥ 1, grade 1 neuropathy, bone marrow, liver and respiratory dysfunction ≥ 2, Child Pugh score=B, cardiovascular diseases, including hypertension, unstable heart disease, diabetes and repeated lung infections, HIV/AIDS: CD4 count<350/ μ l. Weight loss ≥ 20%, while using nephrotoxic drugs.

7.According to the RECIST 1.1 standard, there is at least one measurable and evaluable target lesion; 8.ECOG score 0-1; 9.The expected survival period exceeds 3 months; 10.Female patients of childbearing age must undergo a negative urine pregnancy test before the start of the study.

Exclusion Criteria:

  1. Patients without contraindications for platinum use;
  2. Previously received treatment with anti PD-1, anti PD-L1, or any other immune checkpoint inhibitor;
  3. Previously received targeted therapy such as EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors;
  4. Participated in other interventional clinical trials within 30 days prior to screening;
  5. Other malignant tumors have occurred or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, gastrointestinal intramucosal cancer, breast cancer, skin cancer other than melanoma, and superficial bladder tumor;
  6. Active autoimmune diseases that may worsen during immunotherapy;
  7. A history of immunodeficiency, including HIV testing positive, active viral hepatitis, tuberculosis, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  8. Inoculate with live vaccine within 30 days of administration.
  9. Perform major or planned surgery within 90 days prior to the first administration of the investigational drug;
  10. Pregnant (confirmed by blood or urine HCG testing) or lactating women, or subjects of childbearing age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment;
  11. Individuals who are allergic to the use of drugs or their components in this protocol;
  12. Those who are unwilling to participate in this study or unable to sign an informed consent form.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
Drug: Nituozumab
Nituozumab injection 200mg, administered once a week on the first day, with a duration of at least 60 minutes for a total of 7 times

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete remission rate
Time Frame: 2 years
The rate of patient complete remission
2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan Cancer Hospital and Research Institute

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 17, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCCHEC-02-2023-013

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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