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

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Friendship Hospital
• Treatments: Capecitabine

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.