- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05831930
The Effect of Nitozumab in the Treatment of Head and Neck Squamous Cell Carcinoma
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 Overview
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Yangkun Luo
- Phone Number: 13518161979
- Email: 621199521@qq.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- Sichuan Cancer Hospital and Research Institute
-
Contact:
- Yangkun Luo
- Phone Number: 13518161979
- Email: 621199521@qq.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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:
- 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.
Study Plan
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 |
Intervention / Treatment |
---|---|
Experimental: Treatment Group
|
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
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete remission rate
Time Frame: 2 years
|
The rate of patient complete remission
|
2 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCCHEC-02-2023-013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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