Back to resultsA Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
Primary Purpose
Unresectable Metastatic Colorectal Cancer
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fruquintinib plus capecitabine
Sponsored by
About this trial
This is an interventional treatment trial for Unresectable Metastatic Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- ≥18 years old at the time of signing the informed consent;
- Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
- Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
- Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
- At least one measurable lesion(s);
- ECOG PS 0-2;
- Life expectancy≥3 months;
- Adequate organ and bone marrow functions;
- 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;
- Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion Criteria:
- Previous treatment with VEGFR inhibition;
- Participating in other drug clinical trials within 4 weeks before recruited;
- Have received other systemic anti-tumor therapies within 4 weeks before recruited;
- Non-controlled hypertension after monotherapy, that is, systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg;
- Proteinuria ≥ 2+ (1.0g/24hr);
- Clinically significant electrolyte abnormality;
- Clinically significant cardiovascular diseases;
- Thromboembolism or arteriovenous events occurred 6 months before recruited;
- ≥grade 3 bleeding events 4 weeks before recruited;
- Evidence of CNS metastasis;
- Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
- Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
- History of organ transplantation;
- APTT >1.5×ULN or INR>1.5;
- History of HIV infection or active hepatitis B / C;
- Allergic to fruquintinib and / or capecitabine;
- Pregnant or lactating women;
- Clinically detectable secondary primary malignancies at the time of enrollment (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- Patients who are not suitable for the study judged by the researchers.
Sites / Locations
- Beijing Friendship HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off
Outcomes
Primary Outcome Measures
Objective Response Rate (ORR)
ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Secondary Outcome Measures
Overall Survival (OS)
OS is determined from the date of treatment to death from any cause or the last follow-up date
Progression Free Survival (PFS)
PFS is determined from the date of treatment to PD or death from any cause
Disease Control Rate (DCR)
DCR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Adverse Events and Serious Adverse Events
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Quality of Life (QoL)
Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.
Full Information
NCT ID
NCT04866108
First Posted
April 27, 2021
Last Updated
August 17, 2022
Sponsor
Beijing Friendship Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04866108
Brief Title
A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Metastatic Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off
Intervention Type
Drug
Intervention Name(s)
fruquintinib plus capecitabine
Intervention Description
oral fruquintinib plus capecitabine
Primary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Time Frame
From Baseline to primary completion date, about 3 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is determined from the date of treatment to death from any cause or the last follow-up date
Time Frame
From Baseline to primary completion date, about 3 years
Title
Progression Free Survival (PFS)
Description
PFS is determined from the date of treatment to PD or death from any cause
Time Frame
From Baseline to primary completion date, about 3 years
Title
Disease Control Rate (DCR)
Description
DCR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Time Frame
From Baseline to primary completion date, about 3 years
Title
Adverse Events and Serious Adverse Events
Description
Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.
Time Frame
From Baseline to primary completion date, about 3 years
Title
Quality of Life (QoL)
Description
Quality of life is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit.
Time Frame
From Baseline to primary completion date, about 3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥18 years old at the time of signing the informed consent;
Histologically or cytologically confirmed unresectable metastatic colorectal cancer;
Haven't received systematic therapy after diagnosis of metastatic colorectal cancer;
Intolerable to standard treatment of oxaliplatin- or irinotecan-based intravenous combination therapy;
At least one measurable lesion(s);
ECOG PS 0-2;
Life expectancy≥3 months;
Adequate organ and bone marrow functions;
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;
Willingness and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Exclusion Criteria:
Previous treatment with VEGFR inhibition;
Participating in other drug clinical trials within 4 weeks before recruited;
Have received other systemic anti-tumor therapies within 4 weeks before recruited;
Non-controlled hypertension after monotherapy, that is, systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg;
Proteinuria ≥ 2+ (1.0g/24hr);
Clinically significant electrolyte abnormality;
Clinically significant cardiovascular diseases;
Thromboembolism or arteriovenous events occurred 6 months before recruited;
≥grade 3 bleeding events 4 weeks before recruited;
Evidence of CNS metastasis;
Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
History of organ transplantation;
APTT >1.5×ULN or INR>1.5;
History of HIV infection or active hepatitis B / C;
Allergic to fruquintinib and / or capecitabine;
Pregnant or lactating women;
Clinically detectable secondary primary malignancies at the time of enrollment (excluding fully treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
Patients who are not suitable for the study judged by the researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhigang Bai
Phone
+86-010-63138712
Email
baizhigang@ccmu.edu.cn
Facility Information:
Facility Name
Beijing Friendship Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase II Study of Fruquintinib Combined With Capecitabine as First-line Treatment for Advanced Metastatic Colorectal Cancer Unsuitable for Intravenous Chemotherapy
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