Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer

StatusRecruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from Sunshine Lake Pharma Co., Ltd.

Record History

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  1. Notable Primary completion pushed from Aug 2026 to Aug 2027 Show 4 more changesShow less
    • Study completion pushed from Dec 30, 2026 to Dec 30, 2027
    • Interventions: Irinotecan/Tegafur (Drug), Lerotinib (Drug) to Irinotecan/Tegafur (Drug), Lerotinib (Drug)
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: details revised at 3 of 7 entries
  2. Minor Re-verified, no change to tracked fieldsv7
  3. Notable Primary completion date: Aug 2023 to Aug 2026
    • Study completion date: Nov 2023 to Dec 30, 2026
    v6
  4. Notable Primary completion date: Aug 2022 to Aug 2023
    • Study completion date: Nov 2022 to Nov 2023
    v5
  5. Minor Study site revisedv4
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  1. Notable Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Jul 2021 to Aug 2022
    • Study sites: 0 to 1
    • Study completion date: Jan 2022 to Nov 2022
    • Start date changed from estimate of Oct 2020 to Jan 21, 2021
  2. Notable Start date: Jul 2020 to Oct 2020
    • Study description shortened, about 127 words
    • Eligibility criteria shortened, about 2 words
    v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04415853
Lead Sponsor Sunshine Lake Pharma Co., Ltd.
Conditions
(from sponsor)
Esophageal Cancer
Related terms Esophageal Neoplasms
Enrollment 416 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov