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

NCT ID: NCT04866108

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-08
• Study Completion Date: 2024-06-30

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.

Conditions

Unresectable Metastatic Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Fruquintinib, 4mg/d, qd po, 2 weeks on, 1 week off; Capecitabine: 825mg/m2, bid po, 2 weeks on, 1 week off

Group Type: EXPERIMENTAL

fruquintinib plus capecitabine

Intervention Type: DRUG

oral fruquintinib plus capecitabine

Interventions

fruquintinib plus capecitabine

oral fruquintinib plus capecitabine

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Friendship Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bai Zhigang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Friendship Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhigang Bai

Role: CONTACT

baizhigang@ccmu.edu.cn

+86-010-63138712

References

Wang X, Bai Z, Deng W, Wang X. Efficacy and safety of fruquintinib plus capecitabine as first-line treatment in patients with metastatic colorectal cancer ineligible for intravenous chemotherapy: a two-stage, single-armed, phase II study. Invest New Drugs. 2025 Apr;43(2):214-222. doi: 10.1007/s10637-025-01510-1. Epub 2025 Feb 13.

Reference Type: DERIVED

PMID: 39945972 (View on PubMed)

Other Identifiers

HMPL-013-FLAG-C104

Identifier Type: -

Identifier Source: org_study_id