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

Phase 2

• Conditions: Unresectable Metastatic Colorectal Cancer
• Interventions: Drug: fruquintinib plus capecitabine

• Registration Number: NCT04866108
• Lead Sponsor: Beijing Friendship Hospital

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.

Study Timeline

• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-29
• Study Start: 2021-12-08
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-18
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

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;
11. Active gastric and duodenal ulcer, ulcerative colitis or uncontrolled hemorrhage in GI;
12. Active, symptomatic interstitial lung disease causing dyspnea (≥ grade 2 dyspnea), pleural effusion or ascites;
13. History of organ transplantation;
14. APTT >1.5×ULN or INR>1.5;
15. History of HIV infection or active hepatitis B / C;
16. Allergic to fruquintinib and / or capecitabine;
17. Pregnant or lactating women;
18. 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);
19. Patients who are not suitable for the study judged by the researchers.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	fruquintinib plus capecitabine	Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	From Baseline to primary completion date, about 3 years	ORR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	From Baseline to primary completion date, about 3 years	OS is determined from the date of treatment to death from any cause or the last follow-up date
Progression Free Survival (PFS)	From Baseline to primary completion date, about 3 years	PFS is determined from the date of treatment to PD or death from any cause
Disease Control Rate (DCR)	From Baseline to primary completion date, about 3 years	DCR according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Adverse Events and Serious Adverse Events	From Baseline to primary completion date, about 3 years	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)	From Baseline to primary completion date, about 3 years	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.

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, China