Gastric Cancer Clinical Trial
Official title:
A Multi-center Phase II Study of Trastuzumab Biosimilar (SB3®) in Combination With Ramucirumab and Paclitaxel in HER2 Positive Metastatic Gastric Cancer Patients
The aim of this study is to evaluate the efficacy and safety of combination therapy with ramucirumab, paclitaxel, and trastuzumab biosimilar as second line treatment of HER2 positive metastatic gastric cancer after failure of first line chemotherapy including trastuzumab. This study is a phase II, single-arm, open label, multi-center study.
Approximately 15% of patients with advanced gastric cancer have HER2 overexpression and the
combined use of trastuzumab and other cytotoxic chemotherapeutic agents, such as 5-FU and
cisplatin, in these patients is associated with a significantly improved survival rate
compared with cytotoxic chemotherapy alone. So, the combination of trastuzumab and
chemotherapy is currently being used as a standard treatment in HER2 positive advanced
gastric or gastroesophageal adenocarcinoma. However, after failing first line treatment with
such regimen, second line treatment is determined regardless of HER2 status, and the most
preferred treatment is ramucirumab and paclitaxel combination chemotherapy.
Recently, the use of trastuzumab in combination with other cytotoxic chemotherapeutic agents
has been reported to be superior to the use of cytotoxic chemotherapy alone in the treatment
of patients with HER2 positive metastatic breast cancer. On the basis of several guidelines,
it is recommended to extend the use of trastuzumab after disease progression. In addition, in
some retrospective studies of metastatic gastric cancer, it has been reported that treatment
with trastuzumab in combination with second line chemotherapy followed by first line
chemotherapy including trastuzumab is beneficial and it is worthwhile to be tested in the
prospective study. Furthermore, data on the safety and efficacy of cross-administration of
trastuzumab biosimilar have not been available yet.
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