A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer
A Randomized, Open-label, Parallel Controlled, Multi-center Phase III Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer
1 other identifier
interventional
748
1 country
92
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2021
Longer than P75 for phase_3
92 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
April 21, 2021
CompletedFirst Posted
Study publicly available on registry
April 22, 2021
CompletedStudy Start
First participant enrolled
May 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedJanuary 30, 2026
January 1, 2026
3.6 years
April 21, 2021
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) assessed by IRC
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Baseline up to 15 months
Secondary Outcomes (5)
Progression free survival (PFS)
Baseline up to 15 months
Overall survival (OS)
Baseline up to 20 months
Objective Response Rate（ORR）
Baseline up to 15 months
Disease Control Rate (DCR)
Baseline up to 15 months
Duration of Response (DOR)
Baseline up to 15 months
Study Arms (2)
Anlotinib + CapeOx
EXPERIMENTALAnlotinib 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
ACTIVE COMPARATORBevacizumab 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.
Interventions
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)；
Oxaliplatin 130mg/m2, intravenous drip, on Day 1；
Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.
Eligibility Criteria
You may qualify if:
- \. Understood and Signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy≥ 3 months.
- \. Histologically or cytologically confirmed unresectable metastatic colorectal cancer.
- \. 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.
You may not qualify if:
- 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
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- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (92)
The People's Hospital of Chizhou
Chizhou, Anhui, 247000, China
Fujian Medical University Union Hospital
Fuzhou, Anhui, 350011, China
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Anhui Cancer Hospital
Hefei, Anhui, 230031, China
Xuancheng People's Hospital
Xuancheng, Anhui, 242000, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
Peking University Frist Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
Fuling Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 408099, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350011, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730000, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730030, China
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
Qingyuan People's Hospital
Qingyuan, Guangdong, 511518, China
Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000, China
Liuzhou Workers' Hospital
Liuchow, Guangxi, 545007, China
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 660000, China
Tangshan People's Hospital
Tangshan, Hebei, 63001, China
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 75000, China
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, 150000, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
Huaihe Hospital of Henan University
Kaifeng, Henan, 475000, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
Nanyang Second General Hospital
Nanyang, Henan, 473000, China
Xinyang Central Hospital
Xinyang, Henan, 464099, China
Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
The First Affiliated Hospital of ZhengZhou University
Zhengzhou, Henan, 45000, China
Tongji Hospital Affiliated to Tongji Medical College Hust
Wuhan, Hubei, 430030, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
Hunan Cancer Hospital
Changsha, Hunan, 410013, China
Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, 024000, China
Chifeng Municipal hospital
Chifeng, Inner Mongolia, 024000, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
Jiangsu Cancer hospital
Nanjing, Jiangsu, 210009, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
Nanjing Hospital of C.M.
Nanjing, Jiangsu, 210022, China
Jiangsu Province People's Hospital
Nanjing, Jiangsu, 210029, China
Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
Taizhou Second People's Hospital
Taizhou, Jiangsu, 225300, China
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214062, China
Subei People's Hospital of Jiangsu Province
Yangzhou, Jiangsu, 225001, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
JiangXi PingXiang People's Hospital
Pingxiang, Jiangxi, 337055, China
Jilin Province FAW General Hospital
Changchun, Jilin, 130011, China
Jilin Cancer Hospital
Changchun, Jilin, 130012, China
Meihekou Central Hospital
Meihekou, Jilin, 135022, China
Yanbian University Hospital
Yanji, Jilin, 133099, China
The First Affiliatde Hospital of DaLin Medical University
Dalian, Liaoning, 116011, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012, China
Genertec Liaoyou Gem Flower Hospital
Panjin, Liaoning, 124009, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110801, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Inner Mongolia Autonomous Region Cancer Hospital
Hohhot, Neimenggu, 170000, China
Qinghai University Affiliated Hospital
Xining, Qinghai, 810000, China
3201 Hospital
Hanzhong, Shaanxi, 723000, China
Hanzhong Central Hospital
Hanzhong, Shaanxi, 723000, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710061, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710068, China
The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, Shaanxi, 710068, China
Shandong Cancer Hospital Affiliated to Shandong Univercity
Jinan, Shandong, 250117, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272001, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, 261041, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200032, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200080, China
Changzhi People's Hospital
Changzhi, Shanxi, 46000, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030000, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
Peking University BinHai Hospital
Tianjin, Tianjin Municipality, 300450, China
The First People's Hospital of Kashgar
Kashgar, Xinjiang, 844000, China
Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
Huzhou Cancer Hospital
Huzhou, Zhejiang, 313099, China
Related Publications (1)
He J, Liu Y, Liu C, Hu H, Sun L, Xu D, Li J, Wang J, Chen X, Lin R, Jiang Y, Zhang Y, Zhang W, Cheng Y, Wu X, Fang M, Li E, Xu Y, Chen Y, Li J, Cui Y, Pan Z, Zhang S, Yuan Y, Ding K. A Randomized Phase III Study of Anlotinib Versus Bevacizumab in Combination With CAPEOX as First-Line Therapy for RAS/BRAF Wild-Type Metastatic Colorectal Cancer: A Clinical Trial Protocol. Technol Cancer Res Treat. 2023 Jan-Dec;22:15330338231152350. doi: 10.1177/15330338231152350.
PMID: 36727222DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2021
First Posted
April 22, 2021
Study Start
May 27, 2021
Primary Completion
December 31, 2024
Study Completion (Estimated)
December 1, 2026
Last Updated
January 30, 2026
Record last verified: 2026-01