Study of Sorafenib Combined With Gefitinib for Adults With Pancreatic Neuroendocrine Tumors After Previous Treatment Progression

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 treatments impact on disease progression.

A Clinical Study of Sorafenib Combined With Gefitinib for the Treatment of pNET