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

Primary Purpose

HNSCC

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Nituozumab
Sponsored by
Sichuan Cancer Hospital and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HNSCC

Eligibility Criteria

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

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: Patients without contraindications for platinum use; Previously received treatment with anti PD-1, anti PD-L1, or any other immune checkpoint inhibitor; Previously received targeted therapy such as EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors; Participated in other interventional clinical trials within 30 days prior to screening; 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; Active autoimmune diseases that may worsen during immunotherapy; 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; Inoculate with live vaccine within 30 days of administration. Perform major or planned surgery within 90 days prior to the first administration of the investigational drug; 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; Individuals who are allergic to the use of drugs or their components in this protocol; Those who are unwilling to participate in this study or unable to sign an informed consent form.

Sites / Locations

  • Sichuan Cancer Hospital and Research InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Outcomes

Primary Outcome Measures

Complete remission rate
The rate of patient complete remission

Secondary Outcome Measures

Full Information

First Posted
April 16, 2023
Last Updated
April 16, 2023
Sponsor
Sichuan Cancer Hospital and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05831930
Brief Title
The Effect of Nitozumab in the Treatment of Head and Neck Squamous Cell Carcinoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 17, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sichuan Cancer Hospital and Research Institute

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HNSCC

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Nituozumab
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete remission rate
Description
The rate of patient complete remission
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Patients without contraindications for platinum use; Previously received treatment with anti PD-1, anti PD-L1, or any other immune checkpoint inhibitor; Previously received targeted therapy such as EGFR monoclonal antibodies or EGFR tyrosine kinase inhibitors; Participated in other interventional clinical trials within 30 days prior to screening; 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; Active autoimmune diseases that may worsen during immunotherapy; 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; Inoculate with live vaccine within 30 days of administration. Perform major or planned surgery within 90 days prior to the first administration of the investigational drug; 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; Individuals who are allergic to the use of drugs or their components in this protocol; Those who are unwilling to participate in this study or unable to sign an informed consent form.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yangkun Luo
Phone
13518161979
Email
621199521@qq.com
Facility Information:
Facility Name
Sichuan Cancer Hospital and Research Institute
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yangkun Luo
Phone
13518161979
Email
621199521@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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