Fruquintinib Combined With TAS-102 in the Treatment of Patients With Advanced Metastatic CRC

NCT ID: NCT05004831

Last Updated: 2022-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-11
• Study Completion Date: 2024-09-30

Brief Summary

This phase II study aims to explore the efficacy and safety of fruquintinib combined with TAS-102 in the third-line treatment of patients with advanced metastatic colorectal cancer.

Detailed Description

This is a prospective, single center, one-arm phase II study. A total of 54 advanced mCRC patients refractory to standard therapies will be enrolled and administered with fruquintinib (4mg/d, qd po, D1-21, Q4W) combined with TAS-102 (70mg/m2/d, bid po, D1-5, 8-12, Q4W) until intolerable toxicity, disease progression or death. Primary endpoint of this study is PFS and secondary endpoints are OS, ORR, DCR and safety.

Conditions

Metastatic Colorectal Cancer

Study Design

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

Study Groups

fruquintinib plus TAS-102

fruquintinib plus TAS-102, orally given, Q4W

Group Type: EXPERIMENTAL

fruquintinib plus TAS-102

Intervention Type: DRUG

fruquintinib 4mg/d, qd po, D1-21, Q4W; TAS-102 70mg/m2/d, bid po, D1-5, 8-12, Q4W

Interventions

fruquintinib plus TAS-102

fruquintinib 4mg/d, qd po, D1-21, Q4W; TAS-102 70mg/m2/d, bid po, D1-5, 8-12, Q4W

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 and ≤ 75 years of age;

2. Histological or cytological confirmed advanced metastatic colorectal cancer;

3. Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;

4. At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);

5. ECOG performance status of 0-1;

6. Life expectancy ≥ 12 weeks;

7. No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);

8. Signed and dated informed consent;

9. Adequate hepatic, renal, heart, and hematologic functions;

10. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria

1. Pregnant or lactating women;

2. Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;

3. Previous treatment with TAS-102;

4. Participated in clinical trials of other drugs within four weeks before enrollment;

5. Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;

6. International normalized ratio (INR) > 1.5 or partially activated prothrombin time (APTT) > 1.5 × ULN;

7. Clinically significant electrolyte abnormalities;

8. Subjected with hypertension that cannot be controlled by drugs, which is specified as: systolic blood pressure ≥ 140 mmHg and / or diastolic blood pressure ≥ 90 mmHg;

9. Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;

10. Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;

11. Conditions that may cause gastrointestinal bleeding and perforation determined by the researcher;

12. History of arterial thrombosis or deep venous thrombosis within 6 months before enrollment;

13. Stroke and / or transient cerebral ischemia occurred within 12 months before enrollment;

14. Cardiovascular diseases with significant clinical significance;

15. LVEF<50%;

16. Congestive heart failure New York Heart Association (NYHA) grade > 2;

17. Evidence of CNS metastasis;

18. Previous treatment with VEGFR inhibition;

19. Ventricular arrhythmias requiring drug treatment;

20. Proteinuria ≥ 2+ (1.0g/24hr);

21. Coagulation dysfunction, hemorrhagic tendency or receiving anticoagulant therapy;

22. Other malignant tumors in the past 5 years, except skin basal cell or squamous cell carcinoma after radical surgery, or cervical carcinoma in situ;

23. Active infection that is not controlled clinically, such as acute pneumonia, active hepatitis B or hepatitis C;

24. By judgment of the investigator, there are concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Peng Jian-jun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianjun Peng, M.D.

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianjun Peng, M.D.

Role: CONTACT

pjianj@mail.sysu.edu.cn

+8613602263939

Facility Contacts

JIANJUN PENG, PhD

Role: primary

aidigua@hotmail.com

86-20-87332200 ext. 8211

Other Identifiers

HMPL-013-FLAG-C106

Identifier Type: -

Identifier Source: org_study_id