Advances in the Diagnosis and Management of Well-Differentiated Neuroendocrine Neoplasms.
Johannes Hofland, Gregory Kaltsas, Wouter W de Herder
https://pubmed.ncbi.nlm.nih.gov/31555796Actively Recruiting
Age: 18Years - 80Years
All Genders
ID06592989
A Clinical Study of Sorafenib Combined With Gefitinib for the Treatment of Pancreatic Neuroendocrine Tumor Patients Who Have Progressed After Previous Treatment
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-01-10
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
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AI-Summary
What this Trial Is About
Pancreatic neuroendocrine neoplasms (pNENs) are tumors with increasing incidence and limited treatment options, especially after disease progression or drug resistance from current therapies like somatostatin analogues, chemotherapy, and targeted drugs. Existing treatments such as sunitinib and everolimus have shown limited clinical efficacy with low objective response rates. Researchers are investigating new combinations, including sorafenib and gefitinib, based on evidence linking the EGFR pathway to tumor progression and poor survival in pNEN patients. This study evaluates a single treatment group receiving oral sorafenib (250mg) and gefitinib (250mg) daily, each dose taken once a day. Treatment cycles last 4 weeks, aiming to explore the effectiveness and safety of this combination for patients with pNENs who have progressed after prior treatments. Sorafenib is a tyrosine kinase inhibitor targeting VEGFR, FGFR1, and CSF1R, which may help inhibit tumor angiogenesis and regulate immune responses, while gefitinib targets EGFR. Participants will be assessed regularly with imaging every 8 weeks to measure tumor response and progression-free survival, with survival assessments every 12 weeks up to two years. Safety and tolerability of the drug combination will also be evaluated over two years. The study involves a screening process, treatment period, and follow-up evaluations to monitor outcomes and side effects, supporting comprehensive observation of the treatment's impact on disease progression.
CONDITIONS
Brief 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 must understand the study and provide informed consent
- Age between 18 and 80 years old
- Diagnosed with pancreatic neuroendocrine tumors confirmed by histopathology or cytology
- Disease progression after previous treatments such as somatostatin analogues, targeted therapy, or chemotherapy
- At least one measurable lesion by RECIST V1.1 criteria
- At least 7 days since last systemic treatment; palliative radiotherapy completed more than 4 weeks prior
- Expected survival time of 12 weeks or more
- Sufficient organ and bone marrow function
- Male or female patients with fertility must use effective contraception during the study and for 6 months after last study medication
- Women considered fertile unless natural or artificial menopause or sterilization surgery completed
You will not qualify if you...
- Diagnosed with other malignant tumors in the past 5 years, except certain treated skin or cervical cancers
- Receiving other investigational or approved anti-tumor treatments simultaneously
- Contraindications to experimental drugs such as active bleeding, ulcers, intestinal perforation, uncontrolled hypertension, severe heart failure, recent major surgery, severe liver or kidney dysfunction
- Conditions affecting drug absorption or inability to take oral medication
- Known allergy to study drug components or excipients
- Pregnant or breastfeeding women
- Large amounts of pleural effusion or ascites requiring drainage
- Significant metabolic, physical, or laboratory abnormalities limiting safe participation
- Use of Hypericum perforatum or strong CYP3A4 inducers/inhibitors shortly before study
- Other serious illnesses or conditions judged unsuitable by investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 years
Participants take sorafenib and gefitinib orally once daily in 4-week cycles to treat pancreatic neuroendocrine tumors that have progressed after previous treatments.
Baseline visit and visits every 8 weeks for assessment
Follow-up
Duration - Up to 2 years
Researchers conduct survival assessments and evaluate safety and tolerability of the combination therapy.
Visits every 12 weeks
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
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Research Team
J
Jiuliang Yan, M.D.
J
Jiang Long, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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