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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer

Lerotinib Versus Investigator's Choice Single-agent Chemotherapy in Patients With Locally Advanced/Metastatic Esophageal Squamous Cell Carcinoma and EGFR Overexpression That Progressed After Second-line Therapy:Phase 3 Study

Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer (NCT04415853) is a Phase 3 interventional studying Esophageal Cancer, sponsored by Sunshine Lake Pharma Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Esophageal Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 416 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Age:18-75 years, male or female. 2. diagnosed by tissue sample (biopsy-confirmed) squamous cell carcinoma of the esophagus or advanced/metastatic disease. 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. expected to live at least 3 months. 5. Documented objective radiographic or clinical disease progression on two previous lines of standard therapy. 6. Can provide archival tumor tissue sample for biomarker analysis (such as EGFR overexpression/expansion status), biopsies are required if tissue samples cannot be provided 7. Confirmed by the central laboratory as EGFR high expression. 8. Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. 9. Ability to swallow drugs. 10. your organs (liver, kidneys, etc.) are working well enough based on blood tests. 11. Voluntarily join the study and sign willing to sign a consent form ad has good compliance. Who Should NOT Join This Trial: 1. Prior therapies with EGFR targeted drugs including EGFR antibodies. 2. Previously treated with Irinotecan and Tegafur. 3. 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. 4. Not recovered from adverse events due to a previously administered agent. 5. Have undergone major surgery within 4 weeks prior to randomization (not including diagnostic surgery) or expect major surgery during the study period. 6. Previously or currently participating in other clinical trials within 4 weeks before randomization (subjects who have entered the follow-up period are calculated based on the last use of experimental drugs or devices). 7. Received a live vaccine within 28 days before randomization or plan to receive live vaccine after enrollment. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Age:18-75 years, male or female. 2. Histologically or cytologically confirmed squamous cell carcinoma of the esophagus or advanced/metastatic disease. 3. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy of greater than 3 months. 5. Documented objective radiographic or clinical disease progression on two previous lines of standard therapy. 6. Can provide archival tumor tissue sample for biomarker analysis (such as EGFR overexpression/expansion status), biopsies are required if tissue samples cannot be provided 7. Confirmed by the central laboratory as EGFR high expression. 8. Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. 9. Ability to swallow drugs. 10. Adequate organ function. 11. Voluntarily join the study and sign informed consent ad has good compliance. Exclusion Criteria: 1. Prior therapies with EGFR targeted drugs including EGFR antibodies. 2. Previously treated with Irinotecan and Tegafur. 3. 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. 4. Not recovered from adverse events due to a previously administered agent. 5. Have undergone major surgery within 4 weeks prior to randomization (not including diagnostic surgery) or expect major surgery during the study period. 6. Previously or currently participating in other clinical trials within 4 weeks before randomization (subjects who have entered the follow-up period are calculated based on the last use of experimental drugs or devices). 7. Received a live vaccine within 28 days before randomization or plan to receive live vaccine after enrollment. 8. Received a strong inducer or inhibitor of CYP3A4 enzyme within 1 week or received Solivudine or its structurally similar drugs within 56 days prior to randomization. 9. Simultaneously receiving any other anti-tumor treatment. 10. Has a known additional malignancy previously within the last 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin or any other tumor that has been cured。 11. Central nervous system metastasis or uncontrolled central nervous system metastasis currently in need of treatment; or confirmed central nervous system metastasis, but not stable for more than 4 weeks after anti-tumor therapy; spinal cord compression, cancerous meningitis, or meningitis. 12. Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs. 13. Having active gastrointestinal ulcer, active gastrointestinal bleeding, and perforation; 14. Risk of major bleeding or esophageal fistula; 15. Previous or present with interstitial lung disease or immunotherapy-associated pneumonia; currently suffering from drug-induced pneumonia, radiation pneumonitis requiring steroid therapy, or clinically symptomatic active pneumonia, or other moderate to severe lungs that seriously affect lung function disease 16. Active infection during the screening period (including but not limited to infection requiring intravenous drip therapy), or unexplained fever (\> 38.5°C)within 2 weeks prior to randomization. 17. Has congenital or acquired immune deficiency (such as HIV infection). 18. Known active Hepatitis B or C. 19. Has any of the following diseases within the first 12 months of randomization: myocardial infarction, coronary artery bypass grafting or peripheral artery bypass graft surgery, heart failure (NYHA III to IV), etc and unstable angina with 6 months. 20. Has thrombosis or embolism occurred within the first 12 months of randomization, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism with heparin or other similar drugs. 21. QTc interval (QTcF) corrected by Fridericia method\> 470 ms; history of congenital long QT interval syndrome; any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation) Or torsion-type ventricular tachycardia); left ventricular ejection fraction (LVEF) \<50%. 22. Allergies or contraindications to Z650 excipients (mannitol, sodium carboxymethyl starch, micronized silica gel, magnesium stearate, silicified microcrystalline cellulose), or to Irinotecan or Tegafur or its formulation ingredients. 23. Has uncontrolled pleural effusion, pericardial effusion, pelvic effusion, or ascites requiring repeated drainage. 24. Has a history of organ transplantation or a history of allogeneic bone marrow transplantation. 25. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 6 months after the last dose of study medication. 26. Has other serious acute or chronic diseases and are not suitable for participating in clinical trials judged by investigators.

Treatments Being Tested

DRUG

Lerotinib

Specification: 50 mg/capsule and 150 mg/capsule

DRUG

Irinotecan/Tegafur

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Chinese PLA General Hospital
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04415853), the sponsor (Sunshine Lake Pharma Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04415853 clinical trial studying?

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 investig… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04415853?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04415853?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04415853. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04415853. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.