Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib Versus Trifluridine/Tipiracil and Fufuquitinib for Third-line Treatment of Unresectable Metastatic Colorectal Cancer

First Affiliated Hospital of Wenzhou Medical University1 site in 1 country200 target enrollmentMarch 1, 2024

ConditionsMetastatic Colorectal Cancer Drug Therapy

Interventionstrifluridine/tipiracil combined with fufuquitinib fufuquitinib Trifluridine/tipiracil

Drugstrifluridine/tipiracil combined with fufuquitinib fufuquitinib Trifluridine/tipiracil

Overview

Phase: Phase 2
Intervention: trifluridine/tipiracil combined with fufuquitinib
Conditions: Metastatic Colorectal Cancer
Sponsor: First Affiliated Hospital of Wenzhou Medical University
Enrollment: 200
Locations: 1
Primary Endpoint: Progression-free survival
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer.

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

June 1, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•1.Age 18-75 (at the time of signing the informed consent);ECOG PS score: 0-1; Expected survival time \> 3 months.
•2.Patients with advanced colorectal adenocarcinoma confirmed by histopathology who had failed standard first - and second-line treatment.
•3.At least 1 measurable lesion was present according to RECIST1.1 criteria. 4.Good organ function, laboratory tests meet the following criteria:
•Hemoglobin ≥90g/L;Absolute count of neutrophils (ANC) ≥1.5×109/L;Platelet ≥100×109/L;
•ALT and AST≤2.5 upper limit of normal (ULN).ALP≤2.5 ULN;(if liver metastases ≤5 ULN);
•Total bilirubin (TBIL) \< 1.5 ULN;
•Serum creatinine (CR) \<1.5 ULN or creatinine clearance (CCR) ≥50ml/min;
•Serum albumin ≥30g/L;
•International Normalized ratio (INR), prothrombin time (PT), activated partial thrombin time (APTT) ≤1.5ULN;
•Thyrotropin (TSH) ≤ULN;If abnormal, T3 and T4 levels should be investigated, and normal levels can be included.

Exclusion Criteria

•1.Combined disease or history
•.Present or present with other malignancies within 3 years.
•.Have multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea, or intestinal obstruction)
•.Gastrointestinal bleeding or perforation occurred during the first 4 weeks of enrollment
•.Patients with ulcerative colitis, Crohn's disease, and active inflammatory bowel disease during the first 4 weeks of enrollment
•.Uncontrolled pleural effusion, ascites, and moderate or greater pericardial effusion
•.Unmitigated toxic reactions above grade 1 of CTC AE due to any previous treatment, excluding alopecia.
•.Received major surgical treatment or significant traumatic injury within 28 days prior to enrollment
•.Patients with hematemesis, hematochezia, or any bleeding event ≥ CTCS AE level 3 within the previous 3 months, or with any signs of bleeding or history determined by the investigator to be ineligible for enrollment
•.Arteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident, pulmonary embolism, etc