Lerotinib Versus Investigator's Choice Single-agent Chemotherapy in Patients With Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma and EGFR Overexpression That Progressed After Second-line Therapy:Phase 3 Study

Who is this study for? Patients with Esophageal Cancer
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age:18-75 years, male or female.

• Histologically or cytologically confirmed squamous cell carcinoma of the esophagus or advanced/metastatic disease.

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Life expectancy of greater than 3 months.

• Documented objective radiographic or clinical disease progression on two previous lines of standard therapy.

• Can provide archival tumor tissue sample for biomarker analysis (such as EGFR overexpression/expansion status), biopsies are required if tissue samples cannot be provided

• Confirmed by the central laboratory as EGFR high expression.

• Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.

• Ability to swallow drugs.

⁃ Adequate organ function.

⁃ Voluntarily join the study and sign informed consent ad has good compliance.

Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
JianMing Xu, Doctor
jmxu2003@yahoo.com
010-66939843
Time Frame
Start Date: 2021-01-21
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 416
Treatments
Experimental: Lerotinib Arm
350 mg,qd, orally about half an hour after a meal, continuous administration, every 21 days for a treatment cycle.
Active_comparator: Active Comparator Arm
Irinotecan: Intravenously administered at a dose of 180 mg/m2 every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.~Tegafur: 40-60mg po bid(d1-d14),every 21 days as a cycle, continuous drug administration from 1 to 14 days of each cycle, and then stopped 7 days.
Authors
Jianming Xu
Related Therapeutic Areas
Sponsors
Leads: Sunshine Lake Pharma Co., Ltd.

This content was sourced from clinicaltrials.gov

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