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Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703) | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)

Randomized,Double-blind,Placebo-controlled,Multicenter Study to Compare the Efficacy and Safety of Anlotinib Plus BSC Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Chemotherapies(ALTER0703)

NCT02332499•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

Detailed Description

Anlotibib (AL3818) is a kind of innovative medicines approved by State Food and Drug Administration（SFDA:2011L00661） which was researched by Jiangsu Chia-tai Tianqing Pharmaceutical Co., Ltd.To compare the effects and safety of Anlotinib with placebo in patients with metastatic colorectal cancer refractory to standard chemotherapies.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed and dated informed consent；
•2. Histological or cytological documentation of adenocarcinoma of the colon or rectum；
•3. Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)；
•4. Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan；
•5. ECOG PS:0-1,Life expectancy of more than 3 months；
•6. main organs function is normal；
•7. main organs function is normal；

Exclusion Criteria

•1. Prior treatment with Anlotinib；
•2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug；
•3. Known brain metastases；
•4. patients with severe and failed to controlled diseases；
•5. patients occurred venous thromboembolic events within 6 months；

Locations (29)

The 1st Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

The Second Affiliated Hospital, Anhui Medical University

Hefei, Anhui, China

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The 307th Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Gansu Province Tumor Hospital

Lanzhou, Gansu, China

The First Affiliated Hospital of Sun Yat-sen university

Guangzhou, Guangdong, China

Key Dates

Start Date

December 1, 2014

Primary Completion Date

August 18, 2016

Completion Date

March 1, 2019

Last Updated

May 21, 2019

Enrollment

419

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

Anlotinib

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 21, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Anlotinib in Patients With Metastatic Colorectal Cancer（mCRC）(ALTER0703)

Inclusion Criteria

Exclusion Criteria

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