Head and neck squamous cell carcinoma
Conditions
Interventions
Cetuximab beta combined with chemotherapy treatment group:After 6 cycles of induction therapy with docetaxel, cisplatin/carboplatin, and cetuximab ß, subjects who did not experience disease progressio
Sponsors
taikang Tongji(Wuhan) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.With my consent and having signed the informed consent form (ICF), I am willing and able to comply with the planned visits, study treatments, laboratory tests, and other trial procedures. 2.At the time of signing the ICF, the participant must be >= 18 years old, with an expected survival of >= 12 weeks 3.Histologically or cytologically confirmed squamous cell carcinoma of the head and neck, including oral cavity (excluding lip cancer), oropharynx, hypopharynx, larynx, but excluding nasopharyngeal cancer. 4.Imaging studies such as chest-abdomen-pelvis enhanced CT/enhanced MRI/PET-CT have confirmed advanced metastatic squamous cell carcinoma of the head and neck, including oral cavity (excluding lip cancer), oropharynx, hypopharynx, larynx, but excluding nasopharyngeal cancer (AJCC/UICC TNM staging system, IVc stage), with measurable lesions meeting the criteria of the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1). 5.Eastern Cooperative Oncology Group performance status (ECOG) score of 0-2. 6.Appropriate organ function based on the following laboratory values obtained during the screening period: white blood cell count >= 3×10^9/L, absolute neutrophil count >= 1.5×10^9/L, platelet count >= 75×10^9/L, serum total bilirubin <= 1.5×upper limit of normal (UNL), alanine aminotransferase or aspartate aminotransferase <= 2.5×UNL (<= 5×ULN for liver metastasis participants), serum creatinine <= 1.5×UNL. 7.For female participants of childbearing potential, pregnancy must be excluded before enrollment and they must agree to use one medically accepted highly effective contraceptive method (e.g., intrauterine device, oral contraceptives, or condoms) during the study and for 3 months after the last administration of the investigational drug; for male participants whose partners are of childbearing potential, surgical sterilization should be performed, or they should agree to use an effective method of contraception during the study and for 3 months after the last investigational drug administration.
Exclusion criteria
Exclusion criteria: 1.Previous or concurrent active malignancies (except for malignancies treated curatively with no recurrence within 5 years or carcinoma in situ that can be cured with adequate treatment) are excluded. 2.Currently have duodenal ulcers, ulcerative colitis, bowel obstruction, or other conditions judged by the investigator as potentially causing gastrointestinal bleeding or perforation. 3.Within 12 months prior to enrollment in the study, experienced thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, deep vein thrombosis. 4.Within 12 months prior to enrollment in the study, experienced myocardial infarction, severe/unstable angina, heart failure of NYHA class 2 or higher, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure. 5.Within 14 days prior to enrollment in the study, had uncontrollable pleural effusion, ascites, or pericardial effusion despite effective treatment. 6.Presence of unresolved adverse events from previous treatments with Common Terminology Criteria for Adverse Events (CTCAE version 5.0) grade 2 or higher toxicity (excluding anemia, alopecia, skin hyperpigmentation). 7.Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia, etc.). 8.Human Immunodeficiency Virus (HIV) infection or known Acquired Immunodeficiency Syndrome (AIDS), untreated active hepatitis (HBV-DNA >= 500 IU/mL for hepatitis B; HCV-RNA above the lower limit of detection of the analytical method for hepatitis C) or co-infection with hepatitis B and C. 9.History of known or suspected hypersensitivity to any relevant drugs used in the study. 10.Pregnant or lactating women. 11.Reproductive-age women who are not using or refuse to use effective non-hormonal contraception methods (within 2 years post-menopause) or men with potential fertility. 12.Presence of other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, interfere with study results, or are considered unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Objective response rate, ORR;Duration of remission, DOR;Safety and tolerance; | — |
Countries
China
Contacts
Public ContactGe Wei
taikang Tongji(Wuhan) Hospital
Outcome results
None listed