This study is a prospective, single-arm, multicenter, phase Ib/II clinical trial that treats previously untreated patients with locally advanced or metastatic pancreatic cancer using mFOLFIRINOX in combination with anlotinib and sintilimab. The purpose of this trial is to evaluate the efficacy and safety of this treatment regimen and to preliminarily explore the correlation between biomarkers and treatment outcomes.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Based on the mFOLFIRINOX chemotherapy regimen, combined with the safe dose of anlotinib determined in phase Ib and sintilimab.
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGFujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGMengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGObjective response rate, ORR
The Objective response rate (ORR) was defined as the complete response (CR) rate or the partial response (PR) rate according to RECIST v1.1.
Time frame: Four weeks after the initiation of medication until the day before surgery
Overall survival, OS
The Overall survival (OS) was defined as the time between receiving treatment and observing death or loss of follow-up for any reason.
Time frame: From date of enrollment until the date of death from any cause, assessed up to 60 months
Progression free survival, PFS
The Progression free survival (PFS) was defined as the time between the start of treatment and the progression of intrahepatic and/or extrahepatic tumors, or the occurrence of death or loss of follow-up for any reason.
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Disease control rate, DCR
The Disease control rate (DCR) was defined as the complete response (CR) rate or the partial response (PR) rate or stable disease (SD) rate according to RECIST v1.1.
Time frame: Four weeks after the initiation of medication until the day before surgery
Toxicity Adverse events
Grade 1-5 AEs according to NCI-CTCAE V5.0.
Time frame: From the initiation of medication, with recordings made whenever an adverse reaction occurs, assessed up to 60 months
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Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
NOT_YET_RECRUITING