Safety and Efficacy of SCT200 in Head and Neck Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT03713372|
Recruitment Status : Not yet recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Anti-EGFR monoclonal antibody||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study of Evaluating Recombinant Human Anti-EGFR Monoclonal Antibody (SCT200) for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma After Failure of Platinum-based Therapy|
|Estimated Study Start Date :||November 30, 2018|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||February 28, 2020|
Experimental: Anti-EGFR monoclonal antibody
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.
Drug: Anti-EGFR monoclonal antibody
Initially, 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 Name: SCT200
- Objective response rate (ORR) [ Time Frame: 1 year ]ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.
- Disease control rate (DCR) [ Time Frame: 1 year ]The achievement of any stable disease（SD）, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.
- Progresssion free survival(PFS) [ Time Frame: 1 year ]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.
- Overall survival(OS) [ Time Frame: 1 year ]OS is defined as time from first dose of SCT200 until the date of death from any cause.
- Immunogenicity [ Time Frame: 1 year ]Serum anti-SCT200 antibody levels before and after administration
- EORTC QLQ-C30 [ Time Frame: 1 year ]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)
- EORTC QLQ-H&N35 [ Time Frame: 1 year ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03713372
|Contact: yan wang, MDemail@example.com|
|Cancer hospital Chinese academy of medical sciences|
|Beijing, Beijing, China|
|Principal Investigator:||yuankai shi, MD||Cancer Institute and Hospital, Chinese Academy of Medical Sciences|