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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Anti-EGFR monoclonal antibody DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression Other Names: • SCT200
Cancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, China
Objective response rate (ORR)
ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.
Time frame: 1 year
Disease control rate (DCR)
The achievement of any stable disease#SD#, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.
Time frame: 1 year
Progresssion free survival(PFS)
PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.
Time frame: 1 year
Overall survival(OS)
OS is defined as time from first dose of SCT200 until the date of death from any cause
Time frame: 1 year
Immunogenicity
Serum anti-SCT200 antibody levels before and after administration
Time frame: 1 year
EORTC QLQ-C30
Median scores for each item and domain will be reported at each time point. 30 items questionnaire with answers ranging from 1=not at all to 4=very much includes five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea \& vomiting and pain) and a global health status/QOL scale. Furthermore, it contains six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties)
Time frame: 1 year
EORTC QLQ-H&N35
European organization for research and treatment of cancer quality of life questionnaire head and neck 35(EORTC QLQ-H \& N 35) is a specific questionnaire developed by the European Organisation for Research and Treatment of Cancer for head and neck cancer. The module includes 35 questions Assessing symptoms and side effects of treatment, social function and body image/sexuality .This scale includes seven symptoms subscales that measure pain, swallowing, senses problems, speech problems, trouble with social eating, trouble with social Contact, and less sexuality, and also has 11 subscales related with teeth, opening mouth, dry mouth, sticky saliva, coughing, ill feeling, weight loss, weight gain, use of painkillers, nutritional supplements, and feeding tubes. Standardize the original scores, with scores ranging from 0 to 100, with higher scores representing more serious problems.
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Time frame: 1 year