Actively Recruiting
mFOLFIRINOX Combined With Anlotinib and Sintilimab as First-Line Therapy for Locally Advanced or Metastatic Pancreatic Cancer in a Phase Ib/II Study
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
Researchers are evaluating the safety and effectiveness of a treatment combining mFOLFIRINOX chemotherapy with the drugs anlotinib and sintilimab for patients with locally advanced or metastatic pancreatic cancer who have not received prior treatment. This phase Ib/II, prospective, single-arm, multicenter trial also aims to explore how certain biomarkers may relate to treatment outcomes. The study involves adults aged 18 to 75 years without gender restrictions. Participants will receive the mFOLFIRINOX chemotherapy regimen along with doses of anlotinib and sintilimab determined to be safe in earlier testing. This combined treatment is given as first-line therapy to evaluate its impact on the cancer. The study does not include a comparison group, focusing instead on monitoring responses to this specific treatment combination. During the study, participants will be closely monitored for their response to the treatment, with the main measure being the objective response rate four weeks after starting medication up until the day before surgery if applicable. Assessments include measuring tumor lesions according to standard criteria, monitoring overall health status, and ensuring safety throughout treatment. Participants are expected to have an ECOG performance status of 0-1 and a life expectancy of at least three months. Safety and treatment effects will be followed during the trial period.
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
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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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