Actively Recruiting
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
Led by Fujian Provincial Hospital · Updated on 2025-01-07
29
Participants Needed
4
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combination treatment for patients with locally advanced or metastatic pancreatic cancer who have not received prior anti-cancer therapy. This prospective, single-arm, multicenter, phase Ib/II clinical trial aims to assess the safety and effectiveness of mFOLFIRINOX combined with anlotinib and sintilimab. The study also explores how certain biomarkers might relate to treatment outcomes. The trial begins with a phase Ib dose-finding part where 6 patients receive anlotinib at 10 mg daily for 14 days every 3 weeks alongside mFOLFIRINOX and sintilimab. If dose-limiting toxicities occur, a lower dose of anlotinib (8 mg) will be tested. Once a safe dose is identified, phase II will proceed using that dose to evaluate the treatment's efficacy and safety as a first-line therapy for pancreatic cancer. Participants will be monitored for tumor response starting four weeks after treatment begins, with ongoing assessments for overall survival, progression-free survival, disease control rate, and adverse events over up to 60 months. The study includes evaluations of measurable cancer lesions, regular safety check-ups, and tracking of any side effects. Participants are expected to have an Eastern Cooperative Oncology Group performance status of 0 or 1 and a minimum expected survival of three months during the trial.
CONDITIONS
Brief Title
mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily sign informed consent
- Age between 18 and 75 years, any gender
- Diagnosed with locally advanced or metastatic pancreatic cancer by histology or cytology
- No prior anti-cancer treatment
- At least one measurable lesion according to RECIST 1.1
- ECOG performance status of 0 or 1
- Expected survival of at least 3 months
- No severe diseases of heart, lungs, brain, liver, kidneys, or other organs
- Women of childbearing age must use contraception during treatment and for 6 months after; men must also use contraception during and for 6 months after treatment
- Negative pregnancy test within 7 days before enrollment and non-lactating
You will not qualify if you...
- Prior or current additional anti-tumor treatments such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine
- Known allergies to any study drugs
- Symptomatic brain metastases or metastases controlled less than 2 months
- Large liver metastasis burden occupying more than 70% of liver volume
- Obstructive jaundice not improved after decompression
- Active or relapsing autoimmune diseases
- History of immunodeficiency or current immunosuppressive therapy
- Bleeding disorders or recent use of full-dose anticoagulants (low-dose aspirin or low molecular weight heparin allowed)
- Serious infections within 4 weeks before study drug use
- History of other cancers within past 5 years except certain cured skin and thyroid cancers
- Mental illness or history of substance abuse
- Pregnant or lactating women
- Other reasons deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive mFOLFIRINOX chemotherapy combined with anlotinib and sintilimab as first-line therapy for locally advanced or metastatic pancreatic cancer.
Treatment administered on days 1-14 every 3 weeks with assessments during each cycle
Trial Site Locations
Total: 4 locations
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Not Yet Recruiting
2
Fujian Provincial Hospital
Fuzhou, Fujian, China
Actively Recruiting
3
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Not Yet Recruiting
4
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China
Not Yet Recruiting
Research Team
M
Mao-Lin Yan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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