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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06255379
• Other study ID #: ZF-2023-387-01
• Secondary ID: HMPL-013-SC-CRC1
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 6, 2024
• Est. completion date: March 21, 2027

Study information

• Verified date: April 2024
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: Yang xiaobing, PhD
• Phone: +86 135-8030-9705
• Email: yangxiaobing2002[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: March 21, 2027
• Est. primary completion date: March 21, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer
• Colorectal Neoplasms
• Metastasis Colorectal Cancer
• Rectal Cancer

Intervention

Drug:
• 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;

Locations

Country	Name	City	State
China	Guangdong Provincial Hospital of Traditional Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)	PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator	from randomization up to progressive disease or EOT due to any cause, up to 2 years
Secondary	Objective response rate(ORR)	Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.	from randomization up to progressive disease or EOT due to any cause, up to 2 years
Secondary	Disease control rate(DCR)	DCR was defined as the percentage of participants who have a confirmed complete response(CR) or partial response(PR) or stable disease(SD) per RECIST 1.1 as assessed by investigator	from randomization up to progressive disease or EOT due to any cause, up to 2 years
Secondary	Overall survival (OS)	OS is the time from enrollment to death due to any cause.	from randomization up to progressive disease or EOT due to any cause, up to 3 years
Secondary	adverse events (AE)	overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.	from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib