Phase II Study of Nimotuzumab and Concurrent Radiotherapy and Capecitabine for Inoperable Locally Advanced or Recurrent Gastric Cancer
There is no standard treatment for patients with inoperable locally advanced or
residual/relapsed gastric cancer. For the former ones, 5-fluorouracil(5-FU) based concurrent
chemoradiotherapy is a recommended treatment regimen. Concurrent capecitabine
chemoradiotherapy showed similar results. So far, more and more studies have shown that
drugs targeting at EGFRs play an important role in antitumor treatment. Nimotuzumab, an
anti-EGFR monoclonal antibody, has shown its safety and efficiency in many phase I/II
studies. Because of poor survival of patients with inoperable locally advanced or
residual/relapsed gastric cancer, the efficiency of nimotuzumab plus concurrent capecitabine
chemoradiotherapy need to be further analyzed.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
progression-free survival: the time between tumor regression to progression
1 year progression-free survival
jing jin, M.D.
Chinese Acedemy of Medical Sciences
China: Food and Drug Administration