Actively Recruiting
mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
Led by Fujian Provincial Hospital · Updated on 2025-01-07
29
Participants Needed
4
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign the informed consent form
- Age between 18 and 75 years inclusive
- 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 criteria
- ECOG performance status score of 0-1
- Expected survival of at least 3 months
- No severe organic diseases of heart, lungs, brain, liver, kidneys, or other organs
- Women of childbearing age must agree to use contraception during treatment and for 6 months after; negative pregnancy test within 7 days before enrollment and non-lactating; men must agree to use contraception during and 6 months after treatment
You will not qualify if you...
- Have received or are currently receiving 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 brain metastases with symptom control less than 2 months
- Large liver metastasis burden occupying more than 70% of liver volume
- Obstructive jaundice with bilirubin not reduced to expected level after decompression
- Active autoimmune diseases or expected relapse of autoimmune diseases (including but not limited to interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism)
- History of immunodeficiency or current use of immunosuppressants, systemic corticosteroids, or other immunosuppressive treatments
- Known bleeding or clotting disorders or recent use of full-dose anticoagulants or thrombolytic drugs (preventive low-dose aspirin or low molecular weight heparin allowed)
- Serious infections within 4 weeks before the study drug use or active pulmonary inflammation requiring antibiotics
- History of other malignant tumors within past 5 years except cured basal cell carcinoma of skin, cervical carcinoma in situ, and papillary thyroid carcinoma
- Mental illness, history of psychotropic drug abuse, alcoholism, or drug addiction
- Pregnant or lactating women
- Deemed unsuitable by investigator for other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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