This study is designed to evaluate the real world efficacy and safety of the liposomal irinotecan (Onivyde®)-based treatment scheme in Chinese patients with locally advanced or metastatic pancreatic cancer, and to compare the efficacy with that of the whole pancreatic cancer population who did not receive relevant treatment.
Age ≥ 18 years old.
Patients with locally advanced or metastatic PDAC diagnosed by pathology.
Patients who received at least one cycle of Nal-IRI (Onivyde®）+ 5-FU/LV treatment.
Patients who have progressed in treatment with gemcitabine or gemcitabine containing regimens in the past.
Confirm pregnant or lactating women.
The patient's clinical data is not available.
The researchers determined that they were not suitable for inclusion in the study due to other circumstances.
Experimental group: 40 patients Control group: Depends on the real world condition of China Pancreas Data Center (CPDC) project.
Cohort
Prospective
Nal-IRI (Onivyde®)-based treatment
DrugNal-IRI (Onivyde®) combined with 5-FU/LV is used for metastatic pancreatic ductal adenocarcinoma patients who have progressed after treatment with gemcitabine. The recommended dose of Nal-IRI (Onivyde®) is 70 mg/m\^2, administered intravenously for 90 minutes, once every 2 weeks. In patients known to be homozygous for the UGT1A1 \* 28 allele, the recommended starting dose of Nal-IRI (Onivyde®) is 50 mg/m\^2, administered intravenously within 90 minutes. Based on tolerance, increase the dose of Nal-IRI (Onivyde®) to 70 mg/m\^2 in subsequent cycles.
Other second-line treatment
DrugOther second-line treatment
Overall Survival (OS)
Overall Survival (OS) is defined as the time from enrollment to death from any cause.
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from first-dose to the first documented disease progression or death
Time To Progress (TTP)
Time To Progress (TTP) is defined as the length of time from first-dose until the date of disease progression
Overall Response Rate (ORR)
Overall Response Rate (ORR) is defined as the percentage of people in this study who have a partial response or complete response (according to RESIST v1.1) to the treatment
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial response or stable disease, according to RESIST v1.1
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RenJi Hospital
Lead sponsor
Servier (Tianjin) Pharmaceutical Co. LTD.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
