Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer

Sponsor
Sunshine Lake Pharma Co., Ltd.
Study ID
NCT04415853
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Lerotinib — DRUG
    Specification: 50 mg/capsule and 150 mg/capsule
  • Irinotecan/Tegafur — DRUG
    Irinotecan:Specification: 2mL: 40mg;5mL:0.1g Tegafur:20mg/capsule

Study Details

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.

Key Dates

Start date
Jan 21, 2021
Status verified
May 2025
Primary completion
Aug 31, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
416 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Overall survival [ Time Frame: up to approximately 22 months ]

Central Contacts

Related Studies