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.
Age: 18 to 75 years old, male or female;
Patients with pancreatic cancer diagnosed by histology or cytology;
Not received anti-tumor system treatment (if received neoadjuvant or adjuvant therapy, need to ensure that the last time is more than 6 months)；
With measurable tumor lesions (spiral CT scan ≥10mm, meet RECIST 1.1 standard);
Previous allergy to irinotecan liposome, other liposome products, fluorouracil and other therapeutic drugs;
previous or concurrent history of other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
Participated in other drug clinical trials within 4 weeks before randomization;
Severe gastrointestinal dysfunction;
Parallel
Irinotecan liposome（40mg/m2）
Drugirinotecan Liposome was administered 40mg/m2, D1，iv. q2w
Nab-paclitaxel
DrugNab-paclitaxel was administered 125mg/m2 D1、D8、D15，iv. q4w
Gemcitabine
Druggemcitabine was administered 1000 mg D1、D8、D15，iv. q4w
Irinotecan Liposome（60mg/m2）
Drugirinotecan Liposome was administered 60mg/m2, D1，iv. q2w
MTD /DLT (phase I)
Maximum Tolerated Dose/Dose Limiting Toxicity
ORR(phase II)
Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.
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.
Overall survival
Defined as the time between signing the informed consent form to death due to various causes.
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.
Incidence of adverse events
Use NCI-CTCAE version 5.0 for classification and grading
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