A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer
- Conditions
- Metastatic Colorectal Cancer
- Interventions
- Registration Number
- NCT04854668
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
This is an open label, randomized, phase Ⅲ study to treat subjects with RAS/BRAF wild-type, unresectable metastatic colorectal cancer. The patients will be randomized into two arms consist of Anlotinib (3 weeks/cycle) + CapeOx and Bevacizumab (3 week/cycle) + CapeOx at a ratio of 1:1. This study is conducted to assess the efficacy and safety of Anlotinib and Chemotherapy as first-line treatment in subjects with RAS/BRAF wild-type Metastatic Colorectal Cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 748
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Understood and Signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy≥ 3 months.
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Histologically or cytologically confirmed unresectable metastatic colorectal cancer.
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Has RAS/BRAF wild-type. 5. Has at least one measurable lesion. 6. Adequate organ function. 7.Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ; No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
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1.Has dMMR/MSI-H. 2. Combined with the following diseases or medical history:
- Previous or co-existing malignancies within 3 years except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors；
- Has many factors that affect the oral administration of drugs；
- Has Gastrointestinal bleeding or perforation within 4 weeks before the first dose；
- Has active inflammatory bowel disease within 4 weeks before the first dose；
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage；
- Patients whose adverse events (except hair loss) caused by previous treatment did not recover to ≤CTCAE 1 degree；
- Has received major surgical procedure、biopsy or obvious traumatic injury within 28 days before the first dose；
- Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary of blood vessels is unclear；
- Has any bleeding event or the level of bleeding events ≥ CTCAE 3；
- Has unhealed wounds, ulcerative or fractures；
- Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism；
- Has a history of psychotropic substance abuse and are unable to quit ；
- Has any severe and / or uncontrolled disease； 3.Tumor related symptoms and treatment
- Has received chemotherapy, surgery, radiotherapy, and other anti-cancer therapy within 4 weeks before the first dose.
- Has received anti-tumor Chinese patent medicine which were approved by NMPA Within 2 weeks before the first dose.
- Previous adjuvant therapy containing anti-vascular or anti-EGFR targeted drugs.
- Has received systematic treatment for advanced colorectal cancer.
- Has symptomatic brain metastases or control of symptoms < 2 month. 4.Has participated in other anticancer drug clinical trials within 4 weeks. 5.According to the judgement of the researchers, there are other factors that may lead to the termination of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anlotinib + CapeOx Anlotinib hydrochloride capsule Anlotinib combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Anlotinib combined with Capecitabine. Bevacizumab + CapeOx Capecitabine Bevacizumab combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Bevacizumab combined with Capecitabine. Anlotinib + CapeOx Oxaliplatin Anlotinib combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Anlotinib combined with Capecitabine. Anlotinib + CapeOx Capecitabine Anlotinib combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Anlotinib combined with Capecitabine. Bevacizumab + CapeOx Bevacizumab Bevacizumab combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Bevacizumab combined with Capecitabine. Bevacizumab + CapeOx Oxaliplatin Bevacizumab combined with CapeOx(Oxaliplatin+Capecitabine) were used for 4-8 cycles, each cycle is 3 weeks. After 8 cycles, the regimen is changed to Bevacizumab combined with Capecitabine.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) assessed by IRC Baseline up to 15 months PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
- Secondary Outcome Measures
Name Time Method Progression free survival (PFS) Baseline up to 15 months PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Overall survival (OS) Baseline up to 20 months OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.
Objective Response Rate（ORR） Baseline up to 15 months Percentage of subjects achieving complete response (CR) and partial response (PR) .
Disease Control Rate (DCR) Baseline up to 15 months Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of Response (DOR) Baseline up to 15 months DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.
Trial Locations
- Locations (92)
The First Affiliated Hospital of ZhengZhou University
🇨🇳Zhengzhou, Henan, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
Changzhi People's Hospital
🇨🇳Changzhi, Shanxi, China
Peking University BinHai Hospital
🇨🇳Tianjin, Tianjin, China
The People's Hospital of Chizhou
🇨🇳Chizhou, Anhui, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Anhui, China
Anhui Cancer Hospital
🇨🇳Hefei, Anhui, China
Xuancheng People's Hospital
🇨🇳Xuancheng, Anhui, China
China-Japan Friendship Hospital
🇨🇳Beijing, Beijing, China
Peking University Frist Hospital
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, Chongqing, China
Fuling Hospital Affiliated to Chongqing University
🇨🇳Chongqing, Chongqing, China
Beijing Friendship Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Gansu Provincial Hospital
🇨🇳Lanzhou, Gansu, China
Gansu Provincial Cancer Hospital
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Liuzhou Workers' Hospital
🇨🇳Liuzhou, Guangxi, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
Qingyuan People's Hospital
🇨🇳Qingyuan, Guangdong, China
The First Affiliated Hospital Of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital of Shantou University Medical College
🇨🇳Shantou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
🇨🇳Zhanjiang, Guangdong, China
The Affiliated Cancer Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China
The First Hospital of Qinhuangdao
🇨🇳Qinhuangdao, Hebei, China
Tangshan People's Hospital
🇨🇳Tangshan, Hebei, China
The First Affiliated Hospital of Hebei North University
🇨🇳Zhangjiakou, Hebei, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, Guizhou, China
Harbin Medical University Affiliated Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Nanyang Second General Hospital
🇨🇳Nanyang, Henan, China
Huaihe Hospital of Henan University
🇨🇳Kaifeng, Henan, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, Henan, China
Xinyang Central Hospital
🇨🇳Xinyang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Tongji Hospital Affiliated to Tongji Medical College Hust
🇨🇳Wuhan, Hubei, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Affiliated Hospital of Chifeng University
🇨🇳Chifeng, Inner Mongolia, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
The First Peoples Hospital of Changzhou
🇨🇳Changzhou, Jiangsu, China
Chifeng Municipal hospital
🇨🇳Chifeng, Inner Mongolia, China
Jiangsu Cancer hospital
🇨🇳Nanjing, Jiangsu, China
Jiangsu Province People's Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Hospital of C.M.
🇨🇳Nanjing, Jiangsu, China
Jiangsu Taizhou People's Hospital
🇨🇳Taizhou, Jiangsu, China
Taizhou Second People's Hospital
🇨🇳Taizhou, Jiangsu, China
Affiliated Hospital of Jiangnan University
🇨🇳Wuxi, Jiangsu, China
Subei People's Hospital of Jiangsu Province
🇨🇳Yangzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
JiangXi PingXiang People's Hospital
🇨🇳Pingxiang, Jiangxi, China
Jilin Province FAW General Hospital
🇨🇳Changchun, Jilin, China
Jilin Cancer Hospital
🇨🇳Changchun, Jilin, China
Meihekou Central Hospital
🇨🇳Meihekou, Jilin, China
Yanbian University Hospital
🇨🇳Yanji, Jilin, China
The First Affiliatde Hospital of DaLin Medical University
🇨🇳Dalian, Liaoning, China
The First Affiliated Hospital of Jinzhou Medical University
🇨🇳Jinzhou, Liaoning, China
Genertec Liaoyou Gem Flower Hospital
🇨🇳Panjin, Liaoning, China
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Inner Mongolia Autonomous Region Cancer Hospital
🇨🇳Hohhot, Neimenggu, China
Qinghai University Affiliated Hospital
🇨🇳Xining, Qinghai, China
3201 Hospital
🇨🇳Hanzhong, Shaanxi, China
Hanzhong Central Hospital
🇨🇳Hanzhong, Shaanxi, China
Xi'an International Medical Center Hospital
🇨🇳Xi'an, Shaanxi, China
Shaanxi Provincial People's Hospital
🇨🇳Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
🇨🇳Xi'an, Shaanxi, China
Affiliated Hospital of Jining Medical University
🇨🇳Jining, Shandong, China
Shandong Cancer Hospital Affiliated to Shandong Univercity
🇨🇳Jinan, Shandong, China
Liaocheng People's Hospital
🇨🇳Liaocheng, Shandong, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
🇨🇳Shanghai, Shanghai, China
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
Weifang Hospital of Traditional Chinese Medicine
🇨🇳Weifang, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Shanxi Provincial People's Hospital
🇨🇳Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
The First People's Hospital of Kashgar
🇨🇳Kashgar, Xinjiang, China
Affiliated Tumor Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Huzhou Cancer Hospital
🇨🇳Huzhou, Zhejiang, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China