Actively Recruiting
Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib for Third-line Treatment of mCRC
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2024-07-03
200
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer.
CONDITIONS
Official Title
Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib for Third-line Treatment of mCRC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years at signing informed consent
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1
- Expected survival time longer than 3 months
- Advanced colorectal adenocarcinoma confirmed by histopathology
- Failure of standard first- and second-line colorectal cancer treatments
- At least one measurable lesion based on RECIST1.1 criteria
- Good organ function with laboratory tests meeting specified thresholds for hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, creatinine, albumin, blood clotting times, and thyroid function
- Left ventricular ejection fraction (LVEF) of 50% or higher by cardiac ultrasound
- Well-controlled hypertension
- Female participants of reproductive age must use contraception during the study and for 6 months after; negative pregnancy test within 7 days prior to enrollment and not breastfeeding
- Male participants must agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Presence of other malignancies within the past 3 years
- Conditions affecting oral medication intake such as inability to swallow, chronic diarrhea, or intestinal obstruction
- Gastrointestinal bleeding or perforation within 4 weeks before enrollment
- Ulcerative colitis, Crohn's disease, or active inflammatory bowel disease within 4 weeks before enrollment
- Uncontrolled pleural effusion, ascites, or moderate to severe pericardial effusion
- Unresolved treatment-related toxicities above grade 1 (except hair loss)
- Major surgery or significant trauma within 28 days before enrollment
- Severe bleeding events within 3 months before enrollment or signs of ongoing bleeding
- Arteriovenous thrombosis events within 6 months such as stroke or pulmonary embolism
- History of substance abuse with inability to abstain
- Severe or uncontrolled diseases including uncontrolled hypertension, unstable angina, recent myocardial infarction, significant heart failure or arrhythmias, active infection, decompensated liver disease, renal failure requiring dialysis, immunodeficiency including HIV, or history of organ transplant
- Poorly controlled diabetes
- Significant proteinuria or albuminuria
- Neurological or psychiatric disorders that impair safety or study compliance
- Any other medical condition judged by the investigator to pose serious risk or interfere with study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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