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NCT04854668

PHASE3

A Study of Anlotinib Hydrochloride Capsule Combined With Chemotherapy as First-line Treatment in Subjects With RAS/BRAF Wild Metastatic Colorectal Cancer

Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

748

Start Date

2021-05-27

Completion Date

2026-12

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Metastatic Colorectal Cancer

Interventions

DRUG

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)；

DRUG

Bevacizumab

Bevacizumab 7.5mg/kg, intravenous drip, on Day 1

DRUG

Oxaliplatin

Oxaliplatin 130mg/m2, intravenous drip, on Day 1；

DRUG

Capecitabine

Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.

Inclusion Criteria: * 1\. Understood and Signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1；Life expectancy≥ 3 months. 3\. Histologically or cytologically confirmed unresectable metastatic colorectal cancer. 4\. 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. Exclusion Criteria: * 1.Has dMMR/MSI-H. 2. Combined with the following diseases or medical history: 1. Previous or co-existing malignancies within 3 years except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors； 2. Has many factors that affect the oral administration of drugs； 3. Has Gastrointestinal bleeding or perforation within 4 weeks before the first dose； 4. Has active inflammatory bowel disease within 4 weeks before the first dose； 5. Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage； 6. Patients whose adverse events (except hair loss) caused by previous treatment did not recover to ≤CTCAE 1 degree； 7. Has received major surgical procedure、biopsy or obvious traumatic injury within 28 days before the first dose； 8. Imaging (CT or MRI) shows that tumor invades large blood vessels or the boundary of blood vessels is unclear； 9. Has any bleeding event or the level of bleeding events ≥ CTCAE 3； 10. Has unhealed wounds, ulcerative or fractures； 11. Has arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism； 12. Has a history of psychotropic substance abuse and are unable to quit ； 13. Has any severe and / or uncontrolled disease； 3.Tumor related symptoms and treatment  1. Has received chemotherapy, surgery, radiotherapy, and other anti-cancer therapy within 4 weeks before the first dose. 2. Has received anti-tumor Chinese patent medicine which were approved by NMPA Within 2 weeks before the first dose. 3. Previous adjuvant therapy containing anti-vascular or anti-EGFR targeted drugs. 4. Has received systematic treatment for advanced colorectal cancer. 5. 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.

Locations (92)

The People's Hospital of Chizhou

Chizhou, Anhui, China

Fujian Medical University Union Hospital

Fuzhou, Anhui, China

Anhui Provincial Hospital

Hefei, Anhui, China

Anhui Cancer Hospital

Hefei, Anhui, China

Xuancheng People's Hospital

Xuancheng, Anhui, China

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Peking University Frist Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fuling Hospital Affiliated to Chongqing University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Gansu Provincial Cancer Hospital

Lanzhou, Gansu, China

Gansu Provincial Hospital

Lanzhou, Gansu, China

Lanzhou University Second Hospital

Lanzhou, Gansu, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Qingyuan People's Hospital

Qingyuan, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

Liuzhou Workers' Hospital

Liuchow, Guangxi, China

The Affiliated Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Guizhou Provincial People's Hospital

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

Harbin Medical University Affiliated Cancer Hospital

Harbin, Heilongjiang, China

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Huaihe Hospital of Henan University

Kaifeng, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

Nanyang Second General Hospital

Nanyang, Henan, China

Xinyang Central Hospital

Xinyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of ZhengZhou University

Zhengzhou, Henan, China

Tongji Hospital Affiliated to Tongji Medical College Hust

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Xiangyang Central Hospital

Xiangyang, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Affiliated Hospital of Chifeng University

Chifeng, Inner Mongolia, China

Chifeng Municipal hospital

Chifeng, Inner Mongolia, China

The First Peoples Hospital of Changzhou

Changzhou, Jiangsu, China

Jiangsu Cancer hospital

Nanjing, Jiangsu, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Nanjing Hospital of C.M.

Nanjing, Jiangsu, China

Jiangsu Province People's Hospital

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

Shandong Cancer Hospital Affiliated to Shandong Univercity

Jinan, Shandong, China

Affiliated Hospital of Jining Medical University

Jining, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Weifang Hospital of Traditional Chinese Medicine

Weifang, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Fudan University Shanghai Cancer Center