mFOLFIRINOX Combined With Anlotinib and Sintilimab as First-Line Therapy for Locally Advanced or Metastatic Pancreatic Cancer: A Prospective, Single-arm, Multicenter, Phase Ib/II Clinical Study
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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;
• Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);
• ECOG PS score of 0-1;
• Expected survival of at least 3 months;
• No severe organic diseases of the heart, lungs, brain, liver, kidneys, or other organs;
• Women of childbearing age must agree to use contraceptive measures during the treatment period and for 6 months after the end of treatment; negative serum or urine pregnancy test within 7 days before study enrollment, and must be non-lactating, men must agree to use contraceptive measures during the study period and for 6 months after the study ends.
Locations
Other Locations
China
First Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Fujian Provincial Hospital
RECRUITING
Fuzhou
Mengchao Hepatobiliary Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Zhangzhou Affiliated Hospital of Fujian Medical University
NOT_YET_RECRUITING
Zhangzhou
Contact Information
Primary
Mao-Lin Yan
yanmaolin74@163.com
0591-88217140
Time Frame
Start Date:2024-12-23
Estimated Completion Date:2027-05
Participants
Target number of participants:29
Treatments
Experimental: mFOLFIRINOX Plus Anlotinib and Sintilimab
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.