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

Guangzhou University of Traditional Chinese Medicine1 site in 1 country52 target enrollmentMay 6, 2024

ConditionsMetastasis Colorectal Cancer Colon Cancer Rectal Cancer

InterventionsFuquinitinib+Tegafur Gimeracil Oteracil

DrugsFuquinitinib+Tegafur Gimeracil Oteracil

Overview

Phase: Phase 2
Intervention: Fuquinitinib+Tegafur Gimeracil Oteracil
Conditions: Metastasis Colorectal Cancer
Sponsor: Guangzhou University of Traditional Chinese Medicine
Enrollment: 52
Locations: 1
Primary Endpoint: Progression Free Survival (PFS)
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 6, 2024

End Date

March 21, 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Guangzhou University of Traditional Chinese Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥ 18 and ≤ 75 years of age;
•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;
•Histologically and/or cytologically documented metastatic colorectal adenocarcinoma;
•Refractory to at least second line standard treatment containing fluorouracil, oxaliplatin and irinotecan;
•At least one measurable lesion (larger than 10 mm in diameter by spiral CT scan or 20mm by conventional CT scan);
•ECOG performance status of 0-1;
•Life expectancy ≥ 12 weeks;
•No previous treatment with vascular endothelial growth factor receptor (VEGFR) inhibitor (TKI);
•Adequate hepatic, renal, heart, and hematologic functions;
•Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria

•Pregnant or lactating women;
•Any factors that influence the usage of oral administration or any disease or condition that affects drug absorption;
•Previous treatment with Tegafur Gimeracil Oteracil ;
•Participated in clinical trials of other drugs within four weeks before enrollment;
•Received other systemic anti-tumor therapy within 4 weeks before enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy and immunotherapy;
•International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN;
•Clinically significant electrolyte abnormalities;
•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;
•Unrelieved toxic reactions higher than CTCAE V5.0 grade 1 caused by any previous anti-cancer treatment;
•Incomplete healing of skin wound, surgical site, traumatic site, severe mucosal ulcer or fracture;

Arms & Interventions

Fuquinitinib +Tegafur Gimeracil Oteracil

Intervention: Fuquinitinib+Tegafur Gimeracil Oteracil

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time Frame: from randomization up to progressive disease or EOT due to any cause, up to 2 years

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

Secondary Outcomes

adverse events (AE)(from day 1 of first dosing to 30days after permanent discontinuation of fruquintinib)
Disease control rate(DCR)(from randomization up to progressive disease or EOT due to any cause, up to 2 years)
Overall survival (OS)(from randomization up to progressive disease or EOT due to any cause, up to 3 years)
Objective response rate(ORR)(from randomization up to progressive disease or EOT due to any cause, up to 2 years)