Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)
- Registration Number
- NCT02332499
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
- Detailed Description
Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.To compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 419
- Signed and dated informed consent；
- Histological or cytological documentation of adenocarcinoma of the colon or rectum；
- Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)；
- Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan；
- ECOG PS:0-1,Life expectancy of more than 3 months；
- main organs function is normal；
- main organs function is normal；
- Prior treatment with Anlotinib；
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
- Known brain metastases；
- patients with severe and failed to controlled diseases；
- patients occurred venous thromboembolic events within 6 months；
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent Anlotinib Anlotinib Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- Primary Outcome Measures
Name Time Method Overall Survival (OS) From randomization until death (up to 24 months)
- Secondary Outcome Measures
Name Time Method Progress free survival (PFS) each 42 days up to PD or death(up to 24 months) Disease Control Rate (DCR) each 42 days up to intolerance the toxicity or PD (up to 24 months) Objective Response Rate (ORR) each 42 days up to intolerance the toxicity or PD (up to 24 months) Number of Participants with Adverse Events as a Measure of Safety and Tolerability Until 30 day safety follow-up visit
Trial Locations
- Locations (29)
The 307th Hospital of Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China
The 1st Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Gansu Province Tumor Hospital
🇨🇳Lanzhou, Gansu, China
Guangxi medical university affiliated tumor hospital
🇨🇳Nanning, Guangxi, China
Harbin medical university affiliated tumor hospital
🇨🇳Haerbin, Heilongjiang, China
The Second xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First People's Hospital of Lianyungang
🇨🇳Lianyungang, Jiangsu, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
Nantong Cancer Hospital
🇨🇳Nantong, Jiangsu, China
Jiangxi Cancer Hospital
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Qilu Hospital，Shandong University
🇨🇳Jinan, Shandong, China
Liaoning Province Tumor Hospital
🇨🇳Shenyang, Liaoning, China
Cancer Hospital of Fudan University
🇨🇳Shanghai, Shanghai, China
Tangdu Hospital of The fourth Military Medical University
🇨🇳Xian, Shanxi, China
Shanxi Cancer Hospital
🇨🇳Xian, Shanxi, China
The First Affiliated Hospital of Xian Jiaotong University
🇨🇳Xian, Shanxi, China
Tianjin Medical University Cancer Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Sun Yat-sen university
🇨🇳Guangzhou, Guangdong, China
Jiangsu Province Hospital
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital, Anhui Medical University
🇨🇳Hefei, Anhui, China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The Sixth Affiliated Hospital of Sun Yat-sen university
🇨🇳Guangzhou, Guangdong, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China