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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Metastatic Colorectal Cancer

Intervention / Treatment
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* Drug: Anlotinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed and dated informed consent； Histological or cytological documentation of adenocarcinoma of the colon or rectum； Subjects with metastatic colorectal cancer (Stage IV),With measurable disease (using RECIST1.1)； Progression during or within 3 months following the last administration of approved standard therapies which must include Fluorouracil or its derivatives, Oxaliplatin, Irinotecan； ECOG PS:0-1,Life expectancy of more than 3 months； main organs function is normal； main organs function is normal； Exclusion Criteria: Prior treatment with Anlotinib； Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study drug； Known brain metastases； patients with severe and failed to controlled diseases； patients occurred venous thromboembolic events within 6 months；

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anlotinib<br>Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: Anlotinib<br>* Anlotinib p.o. qd<br>* Other names: AL3818;|
| Placebo Comparator: Placebo<br>Placebo QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent | Drug: Placebo<br>* Placebo p.o. qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | From randomization until death (up to 24 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progress free survival (PFS) |  | each 42 days up to PD or death(up to 24 months) | 
| Objective Response Rate (ORR) |  | each 42 days up to intolerance the toxicity or PD (up to 24 months) | 
| Disease Control Rate (DCR) |  | each 42 days up to intolerance the toxicity or PD (up to 24 months) | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | Until 30 day safety follow-up visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anlotinib, Metastatic Colorectal Cancer （mCRC）, ALTER0703