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
Overview
- Phase
- Phase 2
- Intervention
- fruquintinib plus capecitabine
- Conditions
- Unresectable Metastatic Colorectal Cancer
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR)
- Last Updated
- 3 years ago
Overview
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.
Investigators
Bai Zhigang
Professor
Beijing Friendship Hospital
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;
Arms & Interventions
Experimental
Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off
Intervention: fruquintinib plus capecitabine
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: From Baseline to primary completion date, about 3 years
ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Secondary Outcomes
- Overall Survival (OS)(From Baseline to primary completion date, about 3 years)
- Progression Free Survival (PFS)(From Baseline to primary completion date, about 3 years)
- Disease Control Rate (DCR)(From Baseline to primary completion date, about 3 years)
- Adverse Events and Serious Adverse Events(From Baseline to primary completion date, about 3 years)
- Quality of Life (QoL)(From Baseline to primary completion date, about 3 years)