recurrent and/or metastatic head and neck squamous cell carcinoma
Conditions
Interventions
Test group:Cetuximab ß combined with chemotherapy
Sponsors
Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed a written informed consent form prior to enrollment; 2. Aged 18–75 years, regardless of gender; 3. Diagnosed with head and neck squamous cell carcinoma (SCCHN) confirmed by histology or cytology; 4. Recurrent and/or metastatic SCCHN not suitable for locoregional treatment. For patients with only recurrent disease (without metastasis), they must have previously received radiotherapy (as adjuvant therapy after surgery or as treatment for locally advanced SCCHN) as "locoregional treatment", and the radiotherapy must have been completed more than 6 months before the screening imaging examination; 5. Having >= 1 measurable lesion (in accordance with the RECIST 1.1 criteria); 6. ECOG performance status score: 0–2; 7. Adequate organ function, as defined by: (1) Routine blood test: Absolute Neutrophil Count (ANC) >= 1.5×10?/L; Platelet (PLT) >= 100×10?/L; Hemoglobin (HGB) >= 90 g/L; (2) Liver function: Aspartate Aminotransferase (AST) = 60 mL/min (if the calculated CrCl = 3 months; No plans for pregnancy, childbirth, or breastfeeding from 2 weeks before the start of study treatment to 3 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1. Having received systemic chemotherapy, excluding chemotherapy administered as part of multimodal therapy for locally advanced disease (such chemotherapy must have been completed more than 6 months before the start of the trial). 2. Having undergone major surgery or radiotherapy within 4 weeks prior to enrollment. 3. A history of prior treatment with epidermal growth factor receptor (EGFR)-targeted monoclonal antibodies or signal transduction inhibitors. 4. Nasopharyngeal carcinoma. 5. Known history of hypersensitivity (allergic reactions) to any component of the study treatment. 6. Active infections, including active tuberculosis, known and confirmed human immunodeficiency virus (HIV) infection, or active hepatitis B virus (HBV)/hepatitis C virus (HCV) infection that causes liver function impairment or cirrhosis. 7. History of solid organ transplantation, autologous/allogeneic stem cell transplantation, or renal replacement therapy. 8. Asymptomatic severe hypertension or hypertensive emergency, defined as resting systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg. 9. Cardiac function impairment, manifested by any of the following conditions: left ventricular ejection fraction (LVEF) = 2 peripheral neuropathy or hearing loss. 13. Subjects who have not recovered from any acute effects of prior surgery, chemotherapy, or radiotherapy (i.e., the effects have not resolved to Grade <= 1 per the Common Terminology Criteria for Adverse Events [CTCAE], Version 5.0). Chronic late toxicities from prior radiotherapy and/or surgery (such as pharyngeal/laryngeal toxicities: xerostomia, speech or swallowing disorders, etc.) are permitted if the nutritional status is stable. 14. Known history of alcohol and/or substance abuse. 15. Medical or psychological conditions that would prevent the subject from completing the trial or signing the informed consent form. 16. A history (past or current) of malignancies other than squamous cell carcinoma of the head and neck (SCCHN), excluding the following: non-melanoma skin cancer treated with curative intent, carcinoma in situ of the cervix, or other cancers treated with curative intent and with no evidence of disease for at least 5 years. 17. Having received any investigational drug within 30 days prior to enrollment. 18. Pregnant subjects (not confirmed by serum beta-human chorionic gonadotropin [ß-HCG] test) or breastfeeding women; or men and women of childbearing potential who are unwilling or unable to use a highly effective contraceptive method to prevent pregnancy from 2 weeks before receiving the study treatment to 3 months after the last dose of the study treatment. A highly effective contraceptive method is defined as one with a low failure rate (< 1% per year) when used correctly and consistently. 19. Concurrently receiving treatment with any protocol-specified prohibited medications. 20. Subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| disease control rate;progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactZhang Jianwen
the Affiliated Hospital of Southwest Medical University
Outcome results
None listed