OncoMatch/Clinical Trials/NCT04415853
Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
Is NCT04415853 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Lerotinib and Irinotecan/Tegafur for esophageal cancer.
Treatment: Lerotinib · Irinotecan/Tegafur — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Biomarker criteria
Required: EGFR high expression (high)
Confirmed by the central laboratory as EGFR high expression.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy
Documented objective radiographic or clinical disease progression on two previous lines of standard therapy.
Cannot have received: EGFR-targeted therapy (EGFR antibodies)
Prior therapies with EGFR targeted drugs including EGFR antibodies.
Cannot have received: topoisomerase inhibitor (Irinotecan)
Previously treated with Irinotecan
Cannot have received: antimetabolite (Tegafur)
Previously treated with ... Tegafur
Cannot have received: anthracycline
Anthracycline ... within 6 weeks
Cannot have received: nitrosourea
nitrosourea ... within 6 weeks
Cannot have received: mitomycin
mitomycin within 6 weeks
Cannot have received: traditional Chinese medicine for anti-tumor
traditional Chinese medicine for anti-tumor within 2 weeks
Cannot have received: immunotherapy
immune anti-tumor therapy within 8 weeks
Cannot have received: other anti-tumor therapies
other anti-tumor therapies within 4 weeks before randomization
Lab requirements
Blood counts
Adequate organ function
Kidney function
Adequate organ function
Liver function
Adequate organ function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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