A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
Anlotinib hydrochloride capsule: 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);
Bevacizumab: Bevacizumab 7.5mg/kg, intravenous drip, on Day 1
Oxaliplatin: Oxaliplatin 130mg/m2, intravenous drip, on Day 1;
Capecitabine: Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.
Study 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.
Eligibility
Primary outcome measure(s)
- 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.
Trial sites (92)
| Facility | City | Region | Status |
|---|---|---|---|
| The People's Hospital of Chizhou | Chizhou | Anhui | |
| Fujian Medical University Union Hospital | Fuzhou | Anhui | |
| Anhui Provincial Hospital | Hefei | Anhui | |
| Anhui Cancer Hospital | Hefei | Anhui | |
| Xuancheng People's Hospital | Xuancheng | Anhui | |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | |
| Peking University Frist Hospital | Beijing | Beijing Municipality | |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | |
| Fuling Hospital Affiliated to Chongqing University | Chongqing | Chongqing Municipality | |
| Fujian Cancer Hospital | Fuzhou | Fujian | |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | |
| Gansu Provincial Cancer Hospital | Lanzhou | Gansu | |
| Gansu Provincial Hospital | Lanzhou | Gansu | |
| Lanzhou University Second Hospital | Lanzhou | Gansu | |
| The First Hospital of Lanzhou University | Lanzhou | Gansu | |
| The First Affiliated Hospital Of Guangzhou Medical University | Guangzhou | Guangdong | |
| Qingyuan People's Hospital | Qingyuan | Guangdong | |
| Cancer Hospital of Shantou University Medical College | Shantou | Guangdong | |
| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | |
| Liuzhou Workers' Hospital | Liuzhou | Guangxi | |
| The Affiliated Cancer Hospital of Guizhou Medical University | Guiyang | Guizhou | |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | |
| The First Hospital of Qinhuangdao | Qinhuangdao | Hebei | |
| Tangshan People's Hospital | Tangshan | Hebei | |
| The First Affiliated Hospital of Hebei North University | Zhangjiakou | Hebei | |
| Harbin Medical University Affiliated Cancer Hospital | Harbin | Heilongjiang | |
| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | |
| Huaihe Hospital of Henan University | Kaifeng | Henan | |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | |
| Nanyang Second General Hospital | Nanyang | Henan | |
| Xinyang Central Hospital | Xinyang | Henan | |
| Henan Cancer Hospital | Zhengzhou | Henan | |
| The First Affiliated Hospital of ZhengZhou University | Zhengzhou | Henan | |
| Tongji Hospital Affiliated to Tongji Medical College Hust | Wuhan | Hubei | |
| Hubei Cancer Hospital | Wuhan | Hubei | |
| Xiangyang Central Hospital | Xiangyang | Hubei | |
| Hunan Cancer Hospital | Changsha | Hunan | |
| Affiliated Hospital of Chifeng University | Chifeng | Inner Mongolia | |
| Chifeng Municipal hospital | Chifeng | Inner Mongolia |
+ 52 more sites — see the full list on the official registry below.
On this site
📄 Avastin (bevacizumab) drug profile →More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04854668 on ClinicalTrials.gov ↗ ← All trials in China