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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| recombinant anti-EGFR monoclonal antibody(SCT200) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Anti-EGFR Monoclonal Antibody(SCT200) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | The achievement of either a partial response (PR) or complete response (CR), according to RECIST 1.1 criteria | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate - left side | The achievement of either a partial response (PR) or complete response (CR), left side mCRC patients treated by SCT200. according to RECIST 1.1 criteria | 1 year |
| Best of response |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiaoling yang | Contact | 0086-10-58628288 | 9492 | xiaoling_yang@sinocelltech.com |
| Name | Affiliation | Role |
|---|---|---|
| yuankai shi, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | China |
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Treated with recombinant anti-EGFR Monoclonal antibody(SCT200)until disease progression
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Single Arm, Open-label
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Number of patients in each response category(CR, PR, SD, PD), according to RECIST 1.1 criteria
| 1 year |
| Duration of response | Defined as the time from the date that the response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever occurs first. | 1 year |
| Disease control rate | The achievement of any a stableresponse(SD), partial response (PR) or complete response (CR), according to RECIST 1.1 criteria | 1 year |
| Time to response | Defined as the time from first dose of SCT200 to documentation of a response.according to RECIST 1.1 criteria | 1 year |
| Progression free survival | Defined as time from first dose of SCT200 until first documentation of Progression or death, whichever comes first, according to RECIST 1.1 criteria | 1 year |
| Overall survival | Defined as the time from first dose of SCT200 until death. | 1 year |
| Cancer hospital Chinese academy of medical sciences | Beijing | Beijing Municipality | China |
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| Chinese PLA General Hospital | Beijing | Beijing Municipality | China |
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| Peking Union Medical College Hospital | Beijing | Beijing Municipality | China |
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| Fujian Cancer Hospital | Fuzhou | Fujian | China |
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| The Sixth Affiliated Hospital Of Sun Yat-sen University | Guangzhou | Guangdong | China |
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| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China |
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| Henan Cancer Hospital. | Zhengzhou | Henan | China |
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| Hunan Cancer Hospital | Changsha | Hunan | China |
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| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
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| Jiangsu Province Hospital | Nanjing | Jiangsu | China |
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| Jilin Cancer Hospital | Changchun | Jilin | China |
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| The First Hospital of Jilin University | Changchun | Jilin | China |
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| The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | China |
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| Xiking Hospital | Xi'an | Shaanxi | China |
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| Lin Yi Cancer Hospital | Linyi | Shandong | China |
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| Zhongshan hospital | Shanghai | Shanghai Municipality | China |
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| West China Hospital, Sichuan University | Chengdu | Sichuan | China |
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| Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin Municipality | China |
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| The First Affiliated Hospital Of Xinjiang Medical University | Ürümqi | Xinjiang | China |
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| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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