Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
ConditionEsophageal Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSunshine Lake Pharma Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Prior therapies with EGFR targeted drugs including EGFR antibodies.
Previously treated with Irinotecan and Tegafur.
Anthracycline, nitrosourea, and mitomycin within 6 weeks; traditional Chinese medicine for anti-tumor within 2 weeks;immune anti-tumor therapy. within 8 weeks;other anti-tumor therapies within 4 weeks before randomization.
Not recovered from adverse events due to a previously administered agent.
Trial design
Design model
Parallel
Treatments tested in this trial
Lerotinib
DrugSpecification: 50 mg/capsule and 150 mg/capsule
Irinotecan/Tegafur
DrugIrinotecan:Specification: 2mL: 40mg;5mL:0.1g Tegafur:20mg/capsule
Treatment groups
416 Participants
are divided into 2 treatment groupsGroup A: Lerotinib ArmExperimental treatment 1 intervention
Group B: Active Comparator ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall survival
Defined as time from date of randomization to date of death due to any cause. OS was calculated using product-limit (Kaplan-Meier) method for censored data.
Time frame
up to approximately 22 monthsSecondary outcomes
1
Progression-free survival
defined as the time from date of randomization until the earliest date of disease progression, as determined by independent central review of objective radiographic disease assessments per RECIST 1.1, or death from any cause, whichever comes first.
Time frame
up to approximately 22 months2
Objective response rate
Objective response rate (ORR) is defined as the percentage of the participants in the analysis population who have a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 by investigators
Time frame
up to approximately 22 months3
Duration of response
Defined as the time from the earliest date of qualifying response until earliest date of disease progression, per RECIST v1.1, or death from any cause, whichever comes first. Includes participants with complete response or partial response
Time frame
up to approximately 22 months4
Changes in health-related quality of life with esophageal cancer symptom scale
To evaluate changes in health-related quality of life in patients with advanced esophageal cancer according to the Questionnaire
Time frame
up to approximately 22 monthsSponsors and contacts
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Source ClinicalTrials.gov