About this trial
To evaluate the efficacy and safety of trifluridine/tipiracil combined with fufuquitinib versus trifluridine/tipiracil and fufuquitinib in patients with unresectable metastatic colorectal cancer.
Eligibility criteria
Qualifiers
1.Age 18-75 (at the time of signing the informed consent);ECOG PS score: 0-1; Expected survival time > 3 months.
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;
Disqualifiers
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
Trial design
Treatments tested in this trial
- trifluridine/tipiracil combined with fufuquitinib
- fufuquitinib
- Trifluridine/tipiracil