Actively Recruiting

Age: 18Years - 80Years
All Genders
ID06592989

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

20

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

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

Eligible

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
Not Eligible

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

AI-Screening

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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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Published Research Related To This Trial

Systemic Therapy for Tumor Control in Metastatic Well-Differentiated Gastroenteropancreatic Neuroendocrine Tumors: ASCO Guideline.

Jaydira Del Rivero, Kimberly Perez, Erin B Kennedy...

https://pubmed.ncbi.nlm.nih.gov/37774329

Everolimus for the treatment of advanced, non-functional neuroendocrine tumours of the lung or gastrointestinal tract (RADIANT-4): a randomised, placebo-controlled, phase 3 study.

James C Yao, Nicola Fazio, Simron Singh...

https://pubmed.ncbi.nlm.nih.gov/26703889

Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group.

Anja Rinke, Hans-Helge Müller, Carmen Schade-Brittinger...

https://pubmed.ncbi.nlm.nih.gov/19704057

Octreotide long-acting release (LAR) in combination with other therapies for treatment of neuroendocrine neoplasia: a systematic review.

Maria Rinzivillo, Ilaria De Felice, Ludovica Magi...

https://pubmed.ncbi.nlm.nih.gov/34012671

Survival and Incidence Patterns of Pancreatic Neuroendocrine Tumors Over the Last 2 Decades: A SEER Database Analysis.

Mohamad Bassam Sonbol, Gina L Mazza, Lanyu Mi...

https://pubmed.ncbi.nlm.nih.gov/35348774

Sequencing Treatments in Patients with Advanced Well-Differentiated Pancreatic Neuroendocrine Tumor (pNET): Results from a Large Multicenter Italian Cohort.

Francesco Panzuto, Elisa Andrini, Giuseppe Lamberti...

https://pubmed.ncbi.nlm.nih.gov/38610840

EGFR is a potential therapeutic target for highly glycosylated and aggressive pancreatic neuroendocrine neoplasms.

Zhiwen Xiao, Huaxiang Xu, Jonathan R Strosberg...

https://pubmed.ncbi.nlm.nih.gov/36891979