mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
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 treatm
| Condition(s) | Locally Advanced Pancreatic Cancer, Metastatic Pancreatic Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Fully understand this study and voluntarily sign the informed consent form; 2. Age between 18 and 75 years inclusive, with no gender restrictions; 3. Patients with locally advanced or metastatic pancreatic cancer diagnosed by histology or cytology; 4. No prior anti-cancer treatment; 5. Patients must have at least one measurable lesion (according to RECIST 1.1 criteria); 6. ECOG PS score of 0-1; 7. Expected survival of at least 3 months; 8. No severe organic diseases of the heart, lungs, brain, liver, kidneys, or other organs; 9. 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-lactatin |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Fujian Provincial Hospital |
| Locations | Fuzhou, Fujian, China; Fuzhou, Fujian, China; Fuzhou, Fujian, China; Zhangzhou, Fujian, China |
| Start date | 2024-12-23 |
| NCT ID | NCT06761027 |
| Official listing | https://clinicaltrials.gov/study/NCT06761027 |