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Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer

NCT04415853 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2025-05-18

No results posted yet for this study

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.

Conditions

  • Esophageal Cancer

Interventions

DRUG

Lerotinib

Specification: 50 mg/capsule and 150 mg/capsule

DRUG

Irinotecan/Tegafur

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

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • JianMing Xu, Doctor · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-21
Primary Completion
2026-08-31
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04415853 on ClinicalTrials.gov