Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer

NCT ID: NCT06255379

Last Updated: 2024-04-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2027-03-21

Brief Summary

This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC

Conditions

Metastasis Colorectal Cancer; Colon Cancer; Rectal Cancer

Study Design

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

Study Groups

Fuquinitinib +Tegafur Gimeracil Oteracil

Group Type: EXPERIMENTAL

Fuquinitinib+Tegafur Gimeracil Oteracil

Intervention Type: DRUG

Fuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)\< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 \< BSA （body surface area）\< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA（body surface area） \>1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w;

Interventions

Fuquinitinib+Tegafur Gimeracil Oteracil

Fuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)\< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 \< BSA （body surface area）\< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA（body surface area） \>1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w;

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 and ≤ 75 years of age;

2. Have fully understood and voluntarily sign the ICF for this study (the icf must be signed before any trial-specific procedures are performed);Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure;

3. Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;

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

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

6. ECOG performance status of 0-1;

7. Life expectancy ≥ 12 weeks;

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

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 Tegafur Gimeracil Oteracil ;

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

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Guangdong Provincial Hospital of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Yang xiaobing, PhD

Role: CONTACT

yangxiaobing2002@126.com

+86 135-8030-9705

Facility Contacts

Li xiaoyan

Role: primary

+86 020-81887233 ext. 35943

Other Identifiers

HMPL-013-SC-CRC102

Identifier Type: OTHER

Identifier Source: secondary_id

ZF-2023-387-01

Identifier Type: -

Identifier Source: org_study_id