Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
This is a randomized, controlled, multi-center, open trial, unresectable locally advanced or
metastatic esophageal squamous cell carcinoma patients that failed at least second-line
treatment and overexpressed EGFR were enrolled and randomly assigned to the experimental
group and control group at a 1: 1 ratio.,who received Larotinib and the chemotherapy regimen
chosen by the investigator (Irinotecan Hydrochloride Injection or Tegafur Gimeracil Oteracil
Potassium Capsule),respecitively.
Subjects are administered until disease progression assessed by the RECIST V1.1 standard
(unless the investigator evaluates that the subject continues to have clinical benefit from
continuing treatment, the subject may be allowed to continue treatment), and begins to
receive new anti-tumor treatment, unacceptable toxicity, withdrawal of informed consent, or
other conditions that meet the criteria for terminating trial treatment / withdrawal from the
trial.
The research phase of this study is divided into pre-screening period (~ D-28), screening
period (D-28 ~ D-1), treatment period, treatment end visit (± 7 days after the last dose),
safety follow-up ( Until 28 ± 7 days after the last dose) and survival follow-up.