Fruquintinib, as a standard treatment for refractory metastatic colorectal cancer (mCRC), has attracted increasing research efforts to explore its innovative strategies in combination with chemotherapy. Trifluridine/tipiracil plus bevacizumab is also a standard treatment for mCRC. This study aims to explore the efficacy and safety of fruquintinib combined with trifluridine/tipiracil versus bevacizumab combined with trifluridine/tipiracil in the treatment of patients with advanced metastatic colorectal cancer who failed standard chemotherapy.
Have a full understanding of this study and voluntarily sign the informed consent form;
Aged 18-75 years old (including 18 and 75 years old);
Diagnosed with advanced metastatic colorectal adenocarcinoma by histopathological examination;
Patients who have previously received first-line oxaliplatin and irinotecan treatment, or have received and failed at least two lines of standard chemotherapy regimens. These standard treatment regimens must include fluoropyrimidine-based drugs, oxaliplatin and irinotecan (with or without bevacizumab or cetuximab). Treatment failure is defined as disease progression occurring during treatment or within 3 months after the last treatment, or intolerable toxic side effects. Each line of treatment must include one or more chemotherapy drugs administered for ≥1 cycle; if recurrence or metastasis occurs during adjuvant/neoadjuvant treatment or within 6 months after completion of adjuvant/neoadjuvant treatment, the adjuvant/neoadjuvant treatment is considered a failure of first-line chemotherapy for advanced disease;
Unable to comply with the study protocol or procedures;
Previous treatment with TAS-102 or vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors (TKIs) (e.g., anlotinib, apatinib, etc.);
Participation in other drug clinical trials within 4 weeks before enrollment;
Have received or is currently receiving other systemic anti-tumor treatments within 4 weeks prior to enrollment;
Parallel
Fruquintinib Combined With trifluridine/tipiracil
DrugExperimental arm: Fruquintinib: 4mg once daily for 21 days on/7 days off, every 28 days; Trifluridine/tipiracil: taken at a recommended dose (based on the results of the safety run-in phase) each time orally twice a day on days 1-5 and 8-12, every 28 days.
Bevacizumab combined with trifluridine/tipiracil
DrugActive Comparator: Bevacizumab: 5 mg /kg, intravenously on days 1,15, every 28 days; Trifluridine/tipiracil: 35 mg/m²orally twice a day on days 1-5 and 8-12, every 28 days.
Progression-free survival (PFS)
PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.
Objective response rate (ORR)
ORR was defined as the percentage of patients with a best overall response of complete response (CR) or partial response (PR) per RECISTv1.1.
Disease control rate (DCR)
DCR was defined as the percentage of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD) per RECISTv1.1.
Overall survival (OS)
OS was defined as the time from the date of randomization to the date of death due to any cause.
Adverse Events (AE)
Adverse Events (AE) as assessed by CTCAE v5.0, including serious adverse events (SAEs)
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