A Phase 1/2 interventional study of Anlotinib combined with Sintilimab in Locally Advanced Pancreatic Cancer and Metastatic Pancreatic Cancer, sponsored by Fujian Provincial Hospital. Recruiting at 4 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-07.
Sponsored by Fujian Provincial Hospital · Phase 1/2, Interventional, and Treatment
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.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 29 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Fujian Provincial Hospital is the lead sponsor of 40 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Phase Ib: 6 patients will receive treatment at dose level-0 and their toxicity will be observed. If 2 or fewer patients experience dose-limiting toxicity, the study will proceed to the phase II part using dose level-0 as the treatment dose. If 3 or more patients have dose-limiting toxicity, another 6 patients will be accrued at a lower dose (dose -1). If two or fewer patients have dose-limiting toxicity, then we proceed with the phase II trial at that dose; otherwise, the trial is discontinued. Dose level - 0: anlotinib at a dose of 10mg per administration, once daily, orally administered on days 1-14, every 3 weeks. Dose level -1: anlotinib at a dose of 8mg per administration, once daily, orally administered on days 1-14, every 3 weeks. Phase II: The efficacy and safety of mFOLFIRINOX combined with anlotinib and sintilimab as first-line treatment for locally advanced or metastatic pancreatic cancer will be conducted at the anlotinib safe dose determined in phase Ib.
Drug: Anlotinib combined with Sintilimab
Based on the mFOLFIRINOX chemotherapy regimen, combined with the safe dose of anlotinib determined in phase Ib and sintilimab.
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 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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Fujian Provincial Hospital