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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer; Colon Cancer; Metastasis Colorectal Cancer
• Intervention / Treatment: Drug: Fuquinitinib+Tegafur Gimeracil Oteracil

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yang xiaobing, PhD; Phone Number: +86 135-8030-9705; Email: yangxiaobing2002@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Guangdong Provincial Hospital of Traditional Chinese Medicine
      • Contact: Li xiaoyan; Phone Number: 35943 +86 020-81887233

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fuquinitinib +Tegafur Gimeracil Oteracil	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;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2024
• Primary Completion (Estimated): March 21, 2027
• Study Completion (Estimated): March 21, 2027

Study Registration Dates

• First Submitted: February 4, 2024
• First Submitted That Met QC Criteria: February 4, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Colorectal cancer; Fruquintinib; mCRC; Tegafur Gimeracil Oteracil
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tegafur
• Other Study ID Numbers: ZF-2023-387-01; HMPL-013-SC-CRC102 (Other Identifier: Hutchmed)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No