Apatinib and Irinotecan Combination Treatment in Unresectable or Metastatic Esophageal Squamous Cell Carcinoma
Status:
Suspended
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Esophageal cancer is a common malignant disease worldwide especially in china. Though
esophagectomy and definitive chemoradiotherapy are standard treatments, disease relapses in
many patients and the prognosis of metastatic ESCC is still poor. For patients with
unresectable or metastatic ESCC, chemotherapy is an important treatment alone or with
radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported effective in ESCC and
is used as first-line treatment of ESCC. As for 2nd-line treatment, both irinotecan and
taxane had been recommended based on data from clinical trials which were most enrolled
esophageal or esophageal-gastric junction adenocarcinoma and with only small sample size.
Therefore, it is still urgently needed to explore effective 2nd-line treatment for ESCC.
Apatinib, also known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical
data had shown that it is effective in the treatment of a variety of solid tumors including
esophageal cancer. It had been approved as a 3rd-line treatment for patients with advanced
gastric cancer by state FDA of China in 2014. And the safety data showed that hemorrhage is
rare and non-fetal which is different from bevacizumab.
Therefore, the investigators initialize this phase II study to explore the efficacy and
safety of irinotecan and apatinib combination treatment in unresectable or metastatic ESCC
patients who failed in 1st-line chemotherapy or chemoradiotherapy.