RecruitingPhase 3NCT04415853

Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer

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


Sponsor

Sunshine Lake Pharma Co., Ltd.

Enrollment

416 participants

Start Date

Jan 21, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new targeted therapy drug called larotinib in people with advanced or recurrent esophageal cancer whose tumors have high levels of a protein called EGFR, and who have already tried two prior treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have squamous cell cancer of the esophagus that is advanced or has spread - Your tumor has high EGFR expression (confirmed by a central lab test) - You have had two prior lines of treatment and your cancer has progressed - You are in good general health (ECOG 0–1) and can swallow medications **You may NOT be eligible if...** - You have previously been treated with any EGFR-targeted drug or antibody - You have had irinotecan or tegafur previously - You have had major surgery within the last 4 weeks - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLerotinib

Specification: 50 mg/capsule and 150 mg/capsule

DRUGIrinotecan/Tegafur

Irinotecan:Specification: 2mL: 40mg;5mL:0.1g Tegafur:20mg/capsule


Locations(1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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NCT04415853


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