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Metastatic Colorectal CancerPhase 3NCT04854668

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

A Phase 3 study testing Anlotinib hydrochloride capsule, Bevacizumab and Oxaliplatin in people with Metastatic Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 92 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
Anlotinib hydrochloride capsule, Bevacizumab and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
748 participants
Where
92 sitesChina
Study dates
27 May 2021to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1.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；
Show all 20Show fewer
  • 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
  • <!-- -->
  • Has received chemotherapy, surgery, radiotherapy, and other anti-cancer therapy within 4 weeks before the first dose.
  • Has received anti-tumor Chinese patent medicine which were approved by NMPA Within 2 weeks before the first dose.
  • Previous adjuvant therapy containing anti-vascular or anti-EGFR targeted drugs.
  • Has received systematic treatment for advanced colorectal cancer.
  • 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.

Trial locations and contacts

92 sites in 1 country.

92 sites in 1 country

China92 sites

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Peking University Frist Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Jilin Province FAW General Hospital

    Changchun, Jilin, 130011

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Changzhi People's Hospital

    Changzhi, Shanxi, 46000

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu, 213000

  • Affiliated Hospital of Chifeng University

    Chifeng, Inner Mongolia, 024000

  • Chifeng Municipal hospital

    Chifeng, Inner Mongolia, 024000

  • The People's Hospital of Chizhou

    Chizhou, Anhui, 247000

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

  • Fuling Hospital Affiliated to Chongqing University

    Chongqing, Chongqing Municipality, 408099

  • The First Affiliatde Hospital of DaLin Medical University

    Dalian, Liaoning, 116011

  • Fujian Medical University Union Hospital

    Fuzhou, Anhui, 350011

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350011

  • The First Affiliated Hospital Of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • The Affiliated Cancer Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550000

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • 3201 Hospital

    Hanzhong, Shaanxi, 723000

  • Hanzhong Central Hospital

    Hanzhong, Shaanxi, 723000

  • Harbin Medical University Affiliated Cancer Hospital

    Harbin, Heilongjiang, 150000

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • Anhui Cancer Hospital

    Hefei, Anhui, 230031

  • Inner Mongolia Autonomous Region Cancer Hospital

    Hohhot, Neimenggu, 170000

  • Huzhou Cancer Hospital

    Huzhou, Zhejiang, 313099

  • Shandong Cancer Hospital Affiliated to Shandong Univercity

    Jinan, Shandong, 250117

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong, 272001

  • The First Affiliated Hospital of Jinzhou Medical University

    Jinzhou, Liaoning, 121012

  • Huaihe Hospital of Henan University

    Kaifeng, Henan, 475000

  • The First People's Hospital of Kashgar

    Kashgar, Xinjiang, 844000

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • Gansu Provincial Cancer Hospital

    Lanzhou, Gansu, 730000

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730030

  • Liaocheng People's Hospital

    Liaocheng, Shandong, 252000

  • Liuzhou Workers' Hospital

    Liuzhou, Guangxi, 545007

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000

  • Meihekou Central Hospital

    Meihekou, Jilin, 135022

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

  • Jiangsu Cancer hospital

    Nanjing, Jiangsu, 210009

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210012

  • Nanjing Hospital of C.M.

    Nanjing, Jiangsu, 210022

  • Jiangsu Province People's Hospital

    Nanjing, Jiangsu, 210029

  • Nanyang Second General Hospital

    Nanyang, Henan, 473000

  • Genertec Liaoyou Gem Flower Hospital

    Panjin, Liaoning, 124009

  • JiangXi PingXiang People's Hospital

    Pingxiang, Jiangxi, 337055

  • Qingyuan People's Hospital

    Qingyuan, Guangdong, 511518

  • The First Hospital of Qinhuangdao

    Qinhuangdao, Hebei, 660000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200032

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200032

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200080

  • Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong, 515031

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110000

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110801

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030000

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, 030000

  • Jiangsu Taizhou People's Hospital

    Taizhou, Jiangsu, 225300

  • Taizhou Second People's Hospital

    Taizhou, Jiangsu, 225300

  • Tangshan People's Hospital

    Tangshan, Hebei, 63001

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Peking University BinHai Hospital

    Tianjin, Tianjin Municipality, 300450

  • Affiliated Tumor Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • Weifang Hospital of Traditional Chinese Medicine

    Weifang, Shandong, 261041

  • Tongji Hospital Affiliated to Tongji Medical College Hust

    Wuhan, Hubei, 430030

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu, 214062

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi, 710061

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi, 710068

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710068

  • The Second Affiliated Hospital of PLA Air Force Military Medical University

    Xi'an, Shaanxi, 710068

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441021

  • Qinghai University Affiliated Hospital

    Xining, Qinghai, 810000

  • Xinyang Central Hospital

    Xinyang, Henan, 464099

  • Xuancheng People's Hospital

    Xuancheng, Anhui, 242000

  • Subei People's Hospital of Jiangsu Province

    Yangzhou, Jiangsu, 225001

  • Yanbian University Hospital

    Yanji, Jilin, 133099

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

  • The First Affiliated Hospital of Hebei North University

    Zhangjiakou, Hebei, 75000

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

  • The First Affiliated Hospital of ZhengZhou University

    Zhengzhou, Henan, 45000

Other trials in China

About this study

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

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.

Being tested
Anlotinib hydrochloride capsule, Bevacizumab, Oxaliplatin, Capecitabine
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anlotinib hydrochloride capsuleDrug

    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)；

  • BevacizumabDrug

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

  • OxaliplatinDrug

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

  • CapecitabineDrug

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

Study groups in NCT04854668
Study groupRoleWhat they receive
Anlotinib + CapeOxExperimentalAnlotinib 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.
Receives: Drug: Anlotinib hydrochloride capsule; Drug: Oxaliplatin; Drug: Capecitabine
Bevacizumab + CapeOxActive 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.
Receives: Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline up to 15 months

Secondary outcomes (5)

  1. Progression free survival (PFS)

    PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.

    Measured: Baseline up to 15 months

  2. Overall survival (OS)

    OS defined as the time from the first dose to death from any cause. Survival time was censored at the date of last contact for patients who were still alive or lost to follow-up.

    Measured: Baseline up to 20 months

  3. Objective Response Rate（ORR）

    Percentage of subjects achieving complete response (CR) and partial response (PR) .

    Measured: Baseline up to 15 months

  4. Disease Control Rate (DCR)

    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

    Measured: Baseline up to 15 months

  5. Duration of Response (DOR)

    DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of disease progression or to death due to any cause, whichever occurred first.

    Measured: Baseline up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2021
  2. Study start27 May 2021
  3. Primary completion31 Dec 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
748 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04854668
Sponsor's protocol ID
ALTN-Ⅲ-02
Status last verified
Jan 2026
First submitted
21 Apr 2021
Last updated
30 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36727222

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anlotinib hydrochloride capsule, Bevacizumab and Oxaliplatin in people with Metastatic Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 92 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 92 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) assessed by IRC (time frame: Baseline up to 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04854668, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.

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