safety and efficacy of sct200 in patients with advanced esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of recombinant anti-egfr monoclonal antibody（sct200）in patients with advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil.

this is a open label, single-arm multicenter phase ib study,and is designed to evaluate objective response rate (orr) in advanced esophageal squamous cell carcinoma progressed following treatment with taxane/platinum/fluorouracil treated with anti-egfr monoclonal antibody sct200.

Eligibility criteria:
inclusion criteria: * males or females. aged 18 to 75 years old; * histologically or cytologically proven squamous cell carcinoma of the esophagus, which is locally unresectable or distant metastatic disease; * disease progressed following standard therapies. patients has treated with taxane/platinum/fluorouracil and/or radiotherapy. failure of standard therapy ：disease progressed or developed non-tolerable toxicity during or within 3 months after last systemic chemotherapy or radical concurrent chemoradiotherapy. for adjuvant therapy/neoadjuvant therapy, disease relapse or progression during treatment or within 6 months after treatment is considered as failure of standard therapy; * according to recist 1.1 , patients must have at least one measurable lesion which was not treated with local treatment such as radiotherapy. tumour lesions situated in a previously irradiated area which have been demonstrated progression in the lesion, are considered measurable; * with an eastern cooperative oncology group (ecog) performance status 0-1; * life expectancy of longer than 3 months ( clinical assessment); * adequate organ and marrow function as defined below: absolute neutrophil count (anc) greater than/equal to 1.5×l09/l; platelets greater than/equal to 75×109/l; hemoglobin greater than/equal to 80g/l; aspartate aminotransferase (ast)/alanine aminotransferase (alt) less than/equal to 3 times uln, or less than/equal to 5 times uln if known liver metastases; total bilirubin less than/equal to 1.5 within institutional limit of normal (uln); serum creatinine less than/equal to 1.5 times uln; electrolyte: magnesium greater than/equal to normal. * women of childbearing potential must not be pregnant as assessed by a negative urine or serum beta hcg test upon admission to the hospital, and must agree to use adequate contraception during the study until to 6 months after the last dose of sct200.for male,if his sexual partners is child-bearing potential, he should use effective contraception from the time of signing the informed consent form until at least 6 months after the last dose of study drug. * able to provide written informed consent and can understand and comply with the requirements of the study; exclusion criteria: * patients with active central nervous system metastasis or a history of central nervous system metastasis;(if the subject has been suspected with central nervous system metastasis,imaging examination confirmation must be performed within 28 days to exclude central nervous system metastasis; * patients with other primary malignancies except cured of non-melanoma skin cancer, carcinoma in situ of cervix or prostatic intraepithelial neoplasia; * patients who are allergic to analogue of sct200 and/or its inactive ingredients; * patients administrated egfr target treatment including egfr tki agent or anti- egfr monoclonal antibody; * within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy, immune therapy, the antibody therapy, radiotherapy) or research drugs, or patients with grade 2 or more adverse reaction caused by previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less); * patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices; * patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery; * patients treated with epo, g-csf or gm-csf; * patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (nyha, greater than ii), uncontrollable severe arrhythmia); * patients occurred myocardial infarction within 6 months; * patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or ct or mri reminder ild ; * patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites); * patients with active hepatitis b or active hepatitis c, etc. (for patients with a history of hepatitis b, whether treated or not, hbv dna ≥104 or ≥ 2000iu/ml, hcv rna≥15iu/ml); hiv antibody positive (if there is no clinical evidence suggesting that there may be hiv infection, there is no need to detect); * patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection); * patients have alcohol or drug addiction; * patients with serious abnormal medical, psychological or laboratory results history which may affect explanation of study results; * subjects are considered not suitable for the study by investigator,who have other conditions that may affect their adherence and the evaluation of study indicators.,

Keywords: carcinoma carcinoma, squamous cell esophageal neoplasms neoplasms, squamous cell esophageal diseases epidermal growth factor receptor egfr sct200