mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFujian Provincial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Fully understand this study and voluntarily sign the informed consent form;
Age between 18 and 75 years inclusive, with no gender restrictions;
Patients with locally advanced or metastatic pancreatic cancer diagnosed by histology or cytology;
No prior anti-cancer treatment;
Disqualifiers
Have already received or are currently receiving additional anti-tumor treatment measures such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine treatment;
Known allergies to any of the drugs in the study;
Symptomatic brain metastases or metastases with symptom control time less than 2 months;
A large liver metastasis burden, occupying more than 70% of the liver volume;
Trial design
Design model
Single group
Treatments tested in this trial
Anlotinib combined with Sintilimab
DrugBased on the mFOLFIRINOX chemotherapy regimen, combined with the safe dose of anlotinib determined in phase Ib and sintilimab.
Treatment groups
29 Participants
are divided into 1 treatment groupGroup A: mFOLFIRINOX Plus Anlotinib and SintilimabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective 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 surgerySecondary outcomes
1
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 months2
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 months3
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 surgery4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov