NCT06761027
mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
Recruiting · Phase 1, Phase 2 · Fujian Provincial Hospital · registry updated 2025-01-07
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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;
Exclusion
- 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;
- Patients with obstructive jaundice whose bilirubin cannot be reduced to the expected level after adequate decompression;
- Presence of any active autoimmune diseases or patients with autoimmune diseases expected to relapse (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes);