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Trial Title:
Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer
NCT ID:
NCT06255379
Condition:
Metastasis Colorectal Cancer
Colon Cancer
Rectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Tegafur
Conditions: Keywords:
Colorectal cancer
Fruquintinib
Tegafur Gimeracil Oteracil
mCRC
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fuquinitinib+Tegafur Gimeracil Oteracil
Description:
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;
Arm group label:
Fuquinitinib +Tegafur Gimeracil Oteracil
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
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Contact:
Last name:
Li xiaoyan
Phone:
+86 020-81887233
Phone ext:
35943
Start date:
May 6, 2024
Completion date:
March 21, 2027
Lead sponsor:
Agency:
Guangzhou University of Traditional Chinese Medicine
Agency class:
Other
Source:
Guangzhou University of Traditional Chinese Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06255379
