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Tests treatment safety and results for Metastatic Colorectal Cancer
Official title Efficacy and Safety of Trifluridine/Tipiracil Combined With Fufuquitinib for Third-line Treatment of mCRC
ClinicalTrials.gov ID: NCT06485713
What this study is testing
What is trifluridine/tipiracil combined with fufuquitinib?
trifluridine/tipiracil combined with fufuquitinib is an investigational medicine, being studied as a potential treatment for metastatic colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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;
You likely can't join if
- 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
See the full eligibility 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...
- 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. 5.cardiac color ultrasound: Left ventricular ejection fraction (LVEF) ≥50%. 6.Hypertension was well...
- 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
- .A history of psychotropic substance abuse and inability to abstain
- .people with any severe and/or uncontrolled disease, including
- Uncontrolled hypertension
- Unstable angina pectoris / ≥ grade 2 cardiogenic chest pain;Myocardial infarction occurred within 12 months before randomization;≥ grade 2 heart failure;Restrictive heart disease;≥ grade 2 atrioventricular block...
- Active infection
- Decompensated cirrhosis, active hepatitis;
- Renal failure requires hemodialysis or peritoneal dialysis
- A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation h.Diabetes with poorly controlled i.Urine routine showed urine protein...
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.