New pill combo aims to fight spread of colorectal cancer
NCT ID NCT04854668
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tests whether adding anlotinib (a daily pill) to standard chemotherapy can help people with a certain type of advanced colorectal cancer live longer without the disease getting worse. About 748 participants with RAS/BRAF wild-type cancer that has spread will receive either anlotinib plus chemo or the current standard treatment (bevacizumab plus chemo). The study is active but no longer recruiting, and results are pending.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anlotinib hydrochloride capsule
- What this could lead to
- If successful, this could offer a new first-line treatment option for people with a specific type of metastatic colorectal cancer, potentially improving how long the cancer is kept under control.
- What could go wrong
- This is a Phase 3 trial, but results are not yet available. The drug may not prove more effective than the current standard treatment, and side effects could be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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748 people
The number who actually took part.
- Started
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May 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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3201 Hospital
Hanzhong, Shaanxi, 723000, China
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Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia, 024000, China
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Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000, China
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Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu, 214062, China
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Affiliated Hospital of Jining Medical University
Jining, Shandong, 272001, China
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Affiliated Tumor Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
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Anhui Cancer Hospital
Hefei, Anhui, 230031, China
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Anhui Provincial Hospital
Hefei, Anhui, 230001, China
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
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Cancer Hospital of Shantou University Medical College
Shantou, Guangdong, 515031, China
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Changzhi People's Hospital
Changzhi, Shanxi, 46000, China
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Chifeng Municipal hospital
Chifeng, Inner Mongolia, 024000, China
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029, China
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First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000, China
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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Fujian Cancer Hospital
Fuzhou, Fujian, 350011, China
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Fujian Medical University Union Hospital
Fuzhou, Anhui, 350011, China
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Fuling Hospital Affiliated to Chongqing University
Chongqing, Chongqing Municipality, 408099, China
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Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730000, China
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Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
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Genertec Liaoyou Gem Flower Hospital
Panjin, Liaoning, 124009, China
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Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
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Hanzhong Central Hospital
Hanzhong, Shaanxi, 723000, China
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Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang, 150000, China
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Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
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Huaihe Hospital of Henan University
Kaifeng, Henan, 475000, China
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Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
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Hunan Cancer Hospital
Changsha, Hunan, 410013, China
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Huzhou Cancer Hospital
Huzhou, Zhejiang, 313099, China
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Inner Mongolia Autonomous Region Cancer Hospital
Hohhot, Neimenggu, 170000, China
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JiangXi PingXiang People's Hospital
Pingxiang, Jiangxi, 337055, China
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Jiangsu Cancer hospital
Nanjing, Jiangsu, 210009, China
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Jiangsu Province People's Hospital
Nanjing, Jiangsu, 210029, China
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Jiangsu Taizhou People's Hospital
Taizhou, Jiangsu, 225300, China
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Jilin Cancer Hospital
Changchun, Jilin, 130012, China
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Jilin Province FAW General Hospital
Changchun, Jilin, 130011, China
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Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
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Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
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Liaoning Cancer Hospital
Shenyang, Liaoning, 110801, China
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Liuzhou Workers' Hospital
Liuzhou, Guangxi, 545007, China
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Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032, China
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Meihekou Central Hospital
Meihekou, Jilin, 135022, China
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Nanjing First Hospital
Nanjing, Jiangsu, 210012, China
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Nanjing Hospital of C.M.
Nanjing, Jiangsu, 210022, China
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Nanyang Second General Hospital
Nanyang, Henan, 473000, China
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Peking University BinHai Hospital
Tianjin, Tianjin Municipality, 300450, China
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Peking University Frist Hospital
Beijing, Beijing Municipality, 100034, China
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Qinghai University Affiliated Hospital
Xining, Qinghai, 810000, China
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Qingyuan People's Hospital
Qingyuan, Guangdong, 511518, China
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Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
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Shandong Cancer Hospital Affiliated to Shandong Univercity
Jinan, Shandong, 250117, China
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Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080, China
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Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200032, China
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Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000, China
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Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030000, China
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Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000, China
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Subei People's Hospital of Jiangsu Province
Yangzhou, Jiangsu, 225001, China
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Taizhou Second People's Hospital
Taizhou, Jiangsu, 225300, China
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Tangshan People's Hospital
Tangshan, Hebei, 63001, China
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The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000, China
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The First Affiliatde Hospital of DaLin Medical University
Dalian, Liaoning, 116011, China
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The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, 510120, China
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The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042, China
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The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, 75000, China
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The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
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The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012, China
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The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710068, China
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
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The First Affiliated Hospital of ZhengZhou University
Zhengzhou, Henan, 45000, China
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The First Hospital of China Medical University
Shenyang, Liaoning, China
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The First Hospital of Lanzhou University
Lanzhou, Gansu, 730030, China
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The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 660000, China
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The First People's Hospital of Kashgar
Kashgar, Xinjiang, 844000, China
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The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
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The People's Hospital of Chizhou
Chizhou, Anhui, 247000, China
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The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
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The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
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The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
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The Second Affiliated Hospital of PLA Air Force Military Medical University
Xi'an, Shaanxi, 710068, China
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Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
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Tongji Hospital Affiliated to Tongji Medical College Hust
Wuhan, Hubei, 430030, China
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Weifang Hospital of Traditional Chinese Medicine
Weifang, Shandong, 261041, China
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Xi'an International Medical Center Hospital
Xi'an, Shaanxi, 710061, China
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Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
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Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200080, China
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Xinyang Central Hospital
Xinyang, Henan, 464099, China
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Xuancheng People's Hospital
Xuancheng, Anhui, 242000, China
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Yanbian University Hospital
Yanji, Jilin, 133099, China
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Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
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Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
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Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a hyaluronic acid drug combo outperform bevacizumab in Hard-to-Treat colon cancer?
- Can a targeted drug boost chemotherapy in advanced colorectal cancer?
- New antibody aims to preserve immune checkpoint while fighting cancer
- Two-Step PET scan aims to spot hidden colorectal cancer spread
- Can a targeted drug conjugate outsmart advanced colorectal cancer?
- Can an antimalarial drug boost immunotherapy against colorectal cancer?