Safety and Efficacy of Recombinant Anti-EGFR Monoclonal Antibody in Patients With Wild-type RAS and BRAF mCRC
Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in Patients With Chemotherapy- Refractory Wild Type RAS and BRAF Metastatic Colorectal Cancer
1 other identifier
interventional
110
1 country
21
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2018
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 11, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedStudy Start
First participant enrolled
February 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJanuary 23, 2018
January 1, 2018
10 months
January 11, 2018
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate
The achievement of either a partial response (PR) or complete response (CR), according to RECIST 1.1 criteria
1 year
Secondary Outcomes (7)
Objective response rate - left side
1 year
Best of response
1 year
Duration of response
1 year
Disease control rate
1 year
Time to response
1 year
- +2 more secondary outcomes
Study Arms (1)
recombinant anti-EGFR monoclonal antibody（SCT200）
EXPERIMENTALInitially, 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.
Interventions
Experimental: recombinant anti-EGFR monoclonal antibody（SCT200） Recombinant Anti-EGFR Monoclonal Antibody（SCT200）. Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression.
Eligibility Criteria
You may qualify if:
- Able to provide written informed consent and can understand and comply with the requirements of the study;
- Men and women ≥ 18 years of age;
- Life expectancy of longer than 3 months ( clinical assessment);
- With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
- Have been diagnosed as mCRC verified histologically;
- 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;
- RAS and BRAF wildtype status of primary colorectal cancer or related metastasis;
- 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.
- 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.
You may not qualify if:
- 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;
- Patients with other primary malignancies within the past 5 years except 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 serious psychological or psychiatric disorders which may affect subject compliance in this clinical study;
- Pregnant or lactating women, or women who planned to be pregnant within 6 months of treatment;
- Patients who were not willing to accept effective contraceptive measures (including male or female subjects) during treatment and within 6 months after treatment;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Cancer hospital Chinese academy of medical sciences
Beijing, Beijing Municipality, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The Sixth Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital.
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Jilin Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Xiking Hospital
Xi'an, Shaanxi, China
Lin Yi Cancer Hospital
Linyi, Shandong, China
Zhongshan hospital
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital Of Xinjiang Medical University
Ürümqi, Xinjiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
yuankai shi, MD
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Single Arm, Open-label
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2018
First Posted
January 23, 2018
Study Start
February 12, 2018
Primary Completion
December 1, 2018
Study Completion
December 1, 2019
Last Updated
January 23, 2018
Record last verified: 2018-01