Clinical Study of Sorafenib Combined With Gefitinib for Treating Pancreatic Neuroendocrine Tumors That Progressed After Previous Treatments
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-01-10
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104 weeks
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What this Trial Is About
Pancreatic neuroendocrine neoplasms (pNENs) are tumors whose incidence is rising, with survival rates varying widely depending on the stage of disease. Existing treatments like somatostatin analogues, chemotherapy, and targeted drugs such as sunitinib and everolimus have limited effectiveness, especially for patients with disease progression or drug resistance. Research indicates that the epidermal growth factor receptor (EGFR) pathway may be a promising target for therapy due to its role in tumor progression and poorer survival outcomes in some patients.
This study evaluates the combination of sorafenib, an oral tyrosine kinase inhibitor targeting VEGFR, FGFR1, and CSF1R, with gefitinib, an EGFR inhibitor, to improve treatment outcomes in patients with pancreatic neuroendocrine tumors who have progressed after prior therapies. Participants will take sorafenib 250 mg and gefitinib 250 mg orally once daily. The study aims to assess whether this dual-targeted approach can enhance anti-tumor effects by inhibiting angiogenesis and modulating immune responses.
Participants will undergo baseline examinations followed by assessments every 8 weeks for up to 2 years to measure tumor response. Survival evaluations will also be conducted every 12 weeks during this period. Researchers will monitor objective response rates and progression-free survival to determine treatment activity and safety. The study involves regular clinical and laboratory assessments to ensure participant safety and treatment adherence throughout the trial.
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Official Title
A Clinical Study of Sorafenib Combined With Gefitinib for the Treatment of pNET
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
Patients who understand the study and agree to participate by signing informed consent
Age between 18 and 80 years old
Diagnosed with pancreatic neuroendocrine tumors confirmed by histopathology or cytology, with disease progression after prior treatments including somatostatin analogues, targeted therapy, or chemotherapy
At least one measurable tumor lesion based on RECIST V1.1 criteria
Completed last systemic treatment at least 7 days ago; palliative radiotherapy allowed if finished more than 4 weeks ago
Expected survival time of at least 12 weeks
Estimated by researchers to potentially benefit from the study
Sufficient organ and bone marrow function
Male or female patients of childbearing potential agree to use effective contraception during the study and for 6 months after last dose; females considered fertile unless postmenopausal or surgically sterile
You will not qualify if you...
Diagnosis of other malignant tumors within past 5 years except treated skin basal cell carcinoma, squamous cell carcinoma, or resected cervical carcinoma in situ or breast cancer
Receiving other investigational or approved anti-tumor treatments concurrently
Contraindications to study drugs such as active bleeding, ulcers, intestinal complications, uncontrolled hypertension, severe heart failure, recent major surgery, or severe liver/kidney dysfunction
Conditions affecting drug absorption or inability to take oral medication
Known allergy to study drugs or their components
Pregnant or breastfeeding women
Large amounts of pleural effusion or ascites requiring drainage
Other significant metabolic, physical, or laboratory abnormalities judged by investigators to affect safety or study results
Use of Hypericum perforatum-containing medications within 3 weeks or strong CYP3A4 inducers/inhibitors within 2 weeks prior to study
Other serious concomitant diseases or conditions that may lead to study termination or affect data collection as judged by investigator
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Sequencing Treatments in Patients with Advanced Well-Differentiated Pancreatic Neuroendocrine Tumor (pNET): Results from a Large Multicenter Italian Cohort.
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