Status and phase
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Treatments
About
The purpose of this study is to evaluate the efficacy and safety of first-line with recombinant anti-EGFR monoclonal antibody#SCT200#and standard chemotherapy in patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.
Full description
This open label, single-arm and multicenter phase II study is designed to evaluate Objective Response Rate (ORR) of first-line with anti-EGFR monoclonal antibody#SCT200#and standard chemotherapy in Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Patients with a history of central nervous system metastasis or a history of central nervous system metastasis before screening. For patients with clinically suspected central nervous system metastasis, imaging confirmation must be performed within 28 days prior to enrollment to exclude central nervous system metastasis;
Received systemic chemotherapy for advanced or metastatic HNSCC, but do not include induction chemotherapy, concurrent chemoradiotherapy or adjuvant chemotherapy (the end of this treatment must be more than 6 months from the first trial);
There are other medical history of malignant tumors, except that the malignant lesions have been treated with therapeutic measures 5 years or more before enrollment and there are no known active lesions. The investigator judges that the risk of recurrence is low; Non-melanoma skin cancer, and no evidence of worsening disease; adequately treated cervical cancer in situ, and no evidence of worsening disease; prostatic intraepithelial neoplasia, no evidence of prostate cancer recurrence;
known to be allergic to antibodies or other components contained in the test drug;
have received EGFR antibodies (such as panitumumab, cetuximab or its analogs), or small molecule EGFR inhibitors (such as gefitinib, erlotinib, lapatinib, etc.);
In the 4 weeks or 4 weeks before enrollment, they received anti-tumor drugs (such as chemotherapy, hormone therapy, immunotherapy, antibody therapy, radiotherapy, etc.) or received research drug treatment and could not be included in the evaluation by the investigator. Pain-free palliative radiotherapy for bones;
At the time of enrollment, patients still had ≥2 peripheral neuropathy or hearing loss;
Patients have been enrolled in other study devices or study drug studies at screening time, or have been deactivated for less than or equal to 4 weeks from other study drugs or study devices;
Conduct or plan major surgery within 4 weeks prior to enrollment;
Received transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GMCSF) within 2 weeks prior to enrollment;
Clinically significant cardiovascular disease (defined as: unstable angina, symptomatic congestive heart failure (New York Heart Association [NYHA]
≥ II), uncontrollable severe arrhythmia);
Myocardial infarction occurred within 6 months prior to enrollment;
History of interstitial lung disease (ILD), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
have clinical symptoms, require clinical intervention or serous effusion (such as pleural effusion and ascites) with a stabilization time of less than 4 weeks;
medical or psychiatric history or laboratory abnormal medical history that may interfere with the interpretation of the results;
Patients who are pregnant or breast-feeding, or who plan to be pregnant during the treatment period and within 6 months after the end of treatment;
Patients (including male or female patients) who are unwilling to receive effective contraception during the treatment period and within 6 months after the end of treatment;
HCV antibody positive; or HIV positive; or HBV test results: HBsAg positive and / or HBcAb positive and HBV DNA ≥ 104 copy number or ≥ 2000 IU / ml;
Patients have active or uncontrollable infections (except for simple urinary tract infections or upper respiratory tract infections) requiring systemic treatment within 2 weeks or 2 weeks prior to enrollment;
known patients have alcohol or drug addiction;
The investigator believes that patients have other conditions that may affect their adherence to protocol adherence and study indicators, and are not suitable for patients participating in the study
Primary purpose
Allocation
Interventional model
Masking
25 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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