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Phase 2
Age: 18Years - 75Years
All Genders
ID06485713
Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib Versus Trifluridine/Tipiracil and Fufuquitinib for Third-line Treatment of Unresectable Metastatic Colorectal Cancer
Led by First Affiliated Hospital of Wenzhou Medical University · Updated on 2024-07-03
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining trifluridine/tipiracil with fufuquitinib compared to using each drug separately for patients with unresectable metastatic colorectal cancer who have not responded to standard first- and second-line treatments. This Phase 2 trial focuses on patients aged 18 to 75 years with advanced colorectal adenocarcinoma and measurable lesions, aiming to find better options for third-line treatment. Participants will be randomly assigned to one of three groups: receiving trifluridine/tipiracil combined with fufuquitinib, fufuquitinib alone, or trifluridine/tipiracil alone. Treatments are given as drug therapies, and the trial includes a double-blind design where neither participants nor researchers know who receives which treatment. The study will last up to 24 weeks for the primary outcome and up to 2 years for secondary outcomes. During the study, participants will undergo evaluations including physical exams, lab tests to check organ functions and blood counts, and imaging assessments to monitor tumor response. Researchers will measure progression-free survival as the main outcome and total survival time as a secondary outcome. Safety and treatment effects will be closely monitored throughout the trial, which is sponsored by the First Affiliated Hospital of Wenzhou Medical University.
CONDITIONS
Brief Title
Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib for Third-line Treatment of mCRC
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at the time of signing informed consent
- ECOG performance status score of 0-1
- Expected survival time longer than 3 months
- Advanced colorectal adenocarcinoma confirmed by histopathology
- Failed standard first- and second-line treatments
- At least one measurable lesion according to RECIST 1.1 criteria
- Good organ function with lab tests meeting specific criteria for hemoglobin, neutrophils, platelets, liver enzymes, bilirubin, creatinine, albumin, coagulation, and thyroid hormones
- Left ventricular ejection fraction 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 before enrollment; not breastfeeding
- Male participants must agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Presence or history 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 prior to enrollment
- Active inflammatory bowel diseases like ulcerative colitis or Crohn's disease within 4 weeks prior to enrollment
- Uncontrolled pleural effusion, ascites, or moderate to severe pericardial effusion
- Unresolved toxic reactions above grade 1 (excluding hair loss) from previous treatments
- Major surgery or significant trauma within 28 days before enrollment
- Severe bleeding events within the last 3 months or signs of bleeding making participation unsafe
- Arteriovenous thrombosis within the last 6 months
- History of psychotropic substance abuse with inability to abstain
- Severe uncontrolled diseases including unstable heart conditions, active infection, decompensated liver disease, renal failure requiring dialysis, or immunodeficiency conditions
- Poorly controlled diabetes
- Significant proteinuria or albuminuria
- History of neurological or psychiatric disorders
- Any other medical condition judged by the investigator to endanger safety or interfere with study completion
AI-Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 24 weeks
Participants receive assigned drug treatments including trifluridine/tipiracil combined with fufuquitinib, fufuquitinib alone, or trifluridine/tipiracil alone as third-line therapy for metastatic colorectal cancer.
Weekly visits for up to 24 weeks
Follow-up
Duration - Up to 2 years
Participants are monitored for overall survival and safety after completing treatment.
Periodic visits during follow-up period
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
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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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