To evaluate the safety and efficacy of simmitinib plus irinotecan liposome in the treatment of advanced esophageal squamous cell carcinoma, and to evaluate the PK of the drug and the correlation between biomarkers and clinical efficacy of simmitinib plus irinotecan liposome.
The experiment was divided into two stages. The first stage is dose escalation stage. Rapid titration and "3+3" dose escalation design were used to observe DLT of simmitinib plus irinotecan liposome, and MTD was determined. The second stage is a randomized controlled study. After RP2D was determined in the first stage, participants were randomly assigned to 3 groups in a 1:1:1 ratio, including simmitinib plus irinotecan liposome, irinotecan liposome, and irinotecan.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
simmitinib plus irinotecan liposome 70 mg/m\^2 every 2 weeks
irinotecan liposome 70 mg/m\^2 every 2 weeks
irinotecan 180mg/m\^2 every 2 weeks
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, China
RECRUITINGDose Escalation Phase: DLT
Dose Limited Toxicity
Time frame: From Cycle 1 Day 1 to Cycle 1 Day 28 (each cycle is 28 days)
Dose Escalation Phase: AE
Incidence rate of Adverse Event
Time frame: From first dose to 30 days post the last dose
Randomized controlled study phase: ORR
Objective Response Rate (ORR) evaluated by investigators based on RECIST 1.1
Time frame: 2 years
DCR
Disease Control Rate
Time frame: 2 years
PFS
Progression-free Survival
Time frame: 2 years
OS
Overall Survival
Time frame: 2 years
DOR
Duration of Objective Response
Time frame: 2 years
Area under plasma concentration (AUC)
Area under the plasma concentration versus time curve (AUC) of simmitinib
Time frame: 2 years
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of simmitinib
Time frame: 2 years
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Time of peak plasma concentration (Tmax)
Time of peak plasma concentration (Tmax) of simmitinib
Time frame: 2 years