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A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy | Clinical Trials | Clareo Health

UNKNOWNPHASE2

A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy

A Single Center, Open-labeled, Single Arm Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy

NCT04866108•Beijing Friendship Hospital

View on ClinicalTrials.gov

Summary

This is a single center, open-labeled, single arm phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients unsuitable for intravenous chemotherapy.

Detailed Description

Fruquintinib is an oral small molecule inhibitor of VEGFR1/2/3, this phase II study aimed to investigate the efficacy and safety of fruquintinib combined with capecitabine as first-line treatment for advanced metastatic colorectal cancer patients of elderly or those unsuitable for intravenous chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years old at the time of signing the informed consent;
•2. Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
•3. Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
•4. Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
•5. At least one measurable lesion(s);
•6. ECOG PS 0-2;
•7. Life expectancy≥3 months;
•8. Adequate organ and bone marrow functions;
•9. Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration;
•10. Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria

•1. Previous treatment with VEGFR inhibition;
•2. Participating in other drug clinical trials within 4 weeks before recruited;
•3. Have received other systemic anti-tumor therapies within 4 weeks before recruited;
•4. Non-controlled hypertension after monotherapy, that is, systolic blood pressure \> 140mmHg or diastolic blood pressure \> 90mmHg;
•5. Proteinuria ≥ 2+ (1.0g/24hr);
•6. Clinically significant electrolyte abnormality;
•7. Clinically significant cardiovascular diseases;
•8. Thromboembolism or arteriovenous events occurred 6 months before recruited;
•9. ≥grade 3 bleeding events 4 weeks before recruited;
•10. Evidence of CNS metastasis;
+9 more criteria

Locations (1)

Beijing Friendship Hospital

Beijing, China

Key Dates

Start Date

December 8, 2021

Primary Completion Date

June 1, 2024

Completion Date

June 1, 2024

Last Updated

August 18, 2022

Enrollment

ESTIMATED participants

Conditions

Unresectable Metastatic Colorectal Cancer

Interventions

fruquintinib plus capecitabine

DRUG

Contacts

Zhigang Bai

CONTACT

+86-010-63138712 baizhigang@ccmu.edu.cn

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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: August 18, 2022Data 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.

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