Nitozumab treatment for advanced head and neck cancer

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

This study is testing if a new treatment combining Nitozumab and radiotherapy can help older patients with advanced head and neck cancer who can't take standard chemotherapy.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Cancer Hospital and Research Institute (Academic / other)
• Drugs / interventions: immunotherapy, Nitozumab, Sinilimab
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT05831930 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of Nitozumab combined with radiotherapy in patients over 70 years old with locally advanced head and neck squamous cell carcinoma (HNSCC) who cannot tolerate cisplatin. The trial focuses on high-risk participants who have undergone surgery for their cancer but are ineligible for cisplatin-based chemoradiation due to various health issues. By assessing the efficacy of this combination therapy, the study aims to provide a new treatment option for this vulnerable patient population.

Who should consider this trial

Good fit: Ideal candidates are patients aged 70 and older with stage III-IVB head and neck squamous cell carcinoma who cannot tolerate cisplatin due to health conditions.

Not a fit: Patients with early-stage head and neck cancer or those who are eligible for cisplatin-based therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for elderly patients with advanced head and neck cancer who are unable to receive standard cisplatin-based treatments.

How similar studies have performed: While there is ongoing research in this area, the specific combination of Nitozumab and radiotherapy for this patient demographic is relatively novel and has not been extensively tested.

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:

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.

Where this trial is running

Chengdu, Sichuan

• Sichuan Cancer Hospital and Research Institute — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Yangkun Luo

Conditions HNSCC