RecruitingPhase 1Phase 2NCT06761027

mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer

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

Sponsor

Fujian Provincial Hospital

Enrollment

29 participants

Start Date

Dec 23, 2024

Study Type

INTERVENTIONAL

Conditions

Metastatic Pancreatic Cancer Locally Advanced Pancreatic Cancer

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of chemotherapy (mFOLFIRINOX), a targeted drug (anlotinib), and an immunotherapy drug (sintilimab) as first-line treatment for people with advanced pancreatic cancer that has either spread locally or to other organs. **You may be eligible if...** - You are between 18 and 75 years old - You have locally advanced or metastatic pancreatic cancer confirmed by biopsy - You have NOT yet received any anti-cancer treatment - You have at least one measurable tumor on imaging - You are in good general health (ECOG 0–1) - You are expected to live at least 3 more months - Your heart, lungs, liver, and kidneys are functioning well **You may NOT be eligible if...** - You have already received treatment for pancreatic cancer - You are pregnant or breastfeeding - You have serious organ disease or poor blood counts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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