This is a Phase I/II , Open-label , Investigator-initiated Trail of liposomal irinotecan,nab-paclitaxel and gemcitabine as First-line Treatment in Advanced pancreatic cancer. The study was designed in two stages, the first stage was the tolerance observation stage, and the second stage was the curative effect expansion stage. The first part of the study is the Dose-finding Phase designed to establish the safety of nab-paclitaxel,gemcitabine and liposomal irinotecan at different dose Levels(40 mg/m2, iv. q2w or 60 mg/m2, iv. q2w). The second part of the study is the Expansion Phase designed to generate additional clinical data at specified doses . This study aims to evaluate the safety and efficacy of liposomal irinotecan,nab-paclitaxel and gemcitabine in the First-line treatment of advanced pancreatic cancer.
The study consists of a dose escalation and expansion phase to determine the recommended Phase 2 dose (RP2D) for liposomal irinotecan combination with AG, and a dose confirmation phase which will further characterize the treatment of liposomal irinotecan in combination at the RP2D.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
irinotecan Liposome was administered 40mg/m2, D1,iv. q2w
Nab-paclitaxel was administered 125mg/m2 D1、D8、D15,iv. q4w
gemcitabine was administered 1000 mg D1、D8、D15,iv. q4w
irinotecan Liposome was administered 60mg/m2, D1,iv. q2w
MTD /DLT (phase I)
Maximum Tolerated Dose/Dose Limiting Toxicity
Time frame: Within four weeks after administration
ORR(phase II)
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
Time frame: 6 months
Progression free Survival
Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.
Time frame: 1 year
Overall survival
Defined as the time between signing the informed consent form to death due to various causes.
Time frame: 2 years
Disease Control Rate
Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.
Time frame: 6 months
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.