To evaluate the objective response rate, disease control rate, progression-free survival, overall survival, surgical conversion rate and safety of irinotecan liposome combined with 5-FU/LV+ bevacizumab regimen in first-line treatment of advanced metastatic colorectal cancer patients.
This is a Phase II clinical study to evaluate the efficacy and safety of the combination regimen of irinotecan liposome injection in the first-line treatment of metastatic colorectal cancer. Patients will receive liposomal injections of irinotecan 70mg/m\^2 d1, bevacizumab 5mg/kg d1, LV 400mg/m\^2 d1, 5-FU 400mg/m\^2, then 2400mg/m\^2, continuous intravenous infusion for 46-48h, d1-2. 86 eligible patients will be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
West China Hospital,Sichuan University
Sichuan, Sichuan, Chengdu, China
RECRUITINGObjective response rate
To investigate antitumor efficacy of study.
Time frame: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first . Assessed up to 4 months
Disease control rate
To investigate antitumor efficacy of study.
Time frame: From initial medication to the date of first documented progression or end of medication or completed 8 cycles treatment, whichever came first. Assessed up to 4 months
Progression free survival
To investigate antitumor efficacy of study.
Time frame: From initial medication to the date of first documented progression or end of medication, whichever came first. Assessed up to 30 months.
Overall survival
To investigate antitumor efficacy of study.
Time frame: From initial medication to the date of death from any cause. Assessed up to 30 months.
Percentage of patients undergoing surgery.
To assess surgical conversion rates in patients who could be surgically resected.
Time frame: From the first dose to completed 8 cycles treatment. Assessed up to 5 months.
R0 resection
To assess surgical conversion rates in patients who could be surgically resected.
Time frame: From the first dose to the surgery. Assessed up to 6 months.
Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0
To assess the incidence and severity of adverse events in combination regimens.
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5mg/kg, d1, 14 days per cycle, 8 cycles.
Time frame: From the first dose to completed 8 cycles treatment. Assessed up to 5 months.