Apatinib and Irinotecan Combination Treatment in Esophageal Squamous Cell Carcinoma
Status:
Completed
Trial end date:
2018-12-01
Target enrollment:
Participant gender:
Summary
Esophageal cancer is one of the common malignant tumors. The annual incidence of esophageal
squamous cell carcinoma is 260,000 with the mortality of 210,000 in China. Different from
that in western countries, esophageal squamous cell carcinoma (ESCC) is still the dominant
pathological type in China and account for more than 95% cases in clinic. The prognosis of
ESCC is very poor. About 50% of patients have advanced disease at diagnosis with a 5-year
survival rate of only 5-7%. Though esophagectomy is standard treatment, disease will relapse
in many patients.
For patients with unresectable or recurrent disease, chemotherapy is an important treatment
alone or with radiotherapy. Taxane, platinum, and fluoropyrimidine have been reported
effective in ESCC and is popularly used in first-line treatment of ESCC. However, there is
still no standard 2nd-line treatment for patients who fail in first-line treatment. Both
irinotecan and taxane had been studied as 2nd-line treatment for esophageal cancer patients.
But there are only a few of ESCC patients involved in those studies.
Except for chemotherapy, targeting treatment is another promising treatment for esophageal
cancer. In recent years, antiangiogenic treatment has been proved to be effective and
tolerable in many cancers such lung, colorectal, and gastric cancer. Apatinib is an also
known as YN968D1, is an orally antiangiogenic agents. Preclinical and clinical data has shown
that it is effective in the treatment of a variety of solid tumors including esophageal
cancer. And it was approved and launched in China in 2014 as a 3rd-line treatment for
patients with advanced gastric cancer.
Therefore, investigators initialize this dose escalation phase I study to explore the safety
of irinotecan and apatinib combination treatment in ESCC patients with relapse disease after
esophagectomy and failure in 1st-line chemotherapy. Investigators will analyze the maximum
tolerated dose (MDT) and dose-limiting toxicity (DLT) in this study.