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Active, not recruiting Phase 3

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

NCT04854668 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2021-05-27
Last updated
2026-01-30

Condition(s) studied

Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

Anlotinib hydrochloride capsule →Bevacizumab →Oxaliplatin →Capecitabine →

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

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)

FacilityCityRegionStatus
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.

Official registry record

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