safety and efficacy of recombinant anti-egfr monoclonal antibody in patients with wild-type ras and braf mcrc

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of recombinant anti-egfr monoclonal antibody（sct200）in patients with wild-type ras and braf mcrc treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy


Eligibility criteria:
inclusion criteria: 1. able to provide written informed consent and can understand and comply with the requirements of the study; 2. men and women ≥ 18 years of age; 3. life expectancy of longer than 3 months ( clinical assessment); 4. with an eastern cooperative oncology group (ecog) performance status of ≤ 1; 5. have been diagnosed as mcrc verified histologically; 6. patients treated with fluorouracil, oxaliplatin and irinotecan after failure of standard therapy. disease progressed or developed non-tolerable toxicity after systemic chemotherapy：a. at least one treatment cycle should be completed, and maintenance therapy using one of the doublets is considered as the same line of therapy ; b. may have received adjuvant therapy for primary colorectal cancer provided that at least 6 months have elapsed from the time the adjuvant therapy was concluded and recurrent disease was documented; 7. ras and braf wildtype status of primary colorectal cancer or related metastasis; 8. 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 2.5 times iuln, or less than/equal to 5 times iuln if known liver metastases; total bilirubin less than/equal to 1.5 within institutional upper limit of normal (iuln); serum creatinine less than/equal to 1.5 times iuln; electrolyte: magnesium greater than/equal to normal. 9. according to recist 1.1 , patients must have at least one measurable lesion that can be accurately assessed at baseline and is suitable for repeated assessment by ct, mri. longest diameter greater than/equal to10mm（ct scan slice thickness no greater than 5 mm）, a lymph node must be ≥15mm in short axis when assessed by ct scan. exclusion criteria: 1. patient with active brain metastasis or indicated for symptomatic treatment for brain metastasis, untreated with proper radiation therapy, showing clinical symptoms or symptom stable time less than 28 days; 2. patients with other primary malignancies within the past 5 years except non-melanoma skin cancer, carcinoma in situ of cervix or prostatic intraepithelial neoplasia; 3. patients who are allergic to analogue of sct200 and/or its inactive ingredients; 4. patients administrated egfr target treatment including egfr tki agent or anti- egfr monoclonal antibody; 5. 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); 6. patients are currently enrolled in other research devices or in research drugs, or less than 4 weeks from other research drugs or devices. 7. patients received major surgery(such as need general anesthesia ) within 4 weeks , should recover from the injury associated with the surgery. 8. patients treated with epo, g-csf or gm-csf. 9. patients who have clinically significant cardiovascular disease (defined as unstable angina pectoris, symptomatic congestive heart failure (nyha, greater than ii), uncontrollable severe arrhythmia); 10. patients occurred myocardial infarction within 6 months. 11. patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or ct or mri reminder ild . 12. patients with clinical symptoms, required clinical intervention or stable time less than 4 weeks of serous cavity effusion (such as pleural effusion and ascites); 13. patients with serious psychological or psychiatric disorders which may affect subject compliance in this clinical study; 14. pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment; 15. patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment; 16. 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); 17. patients with uncontrolled active infections before enrollment 2 weeks (except simple urinary tract infection or upper respiratory tract infection); 18. patients have alcohol or drug addiction; 19. inability to comply with study and/or follow-up procedures

Keywords: full human anti-egfr monoclonal antibody (sct200) metastatic colorectal cancer （mcrc）