Esophageal CancerPhase 3NCT04415853
Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
A Phase 3 study testing Lerotinib and Irinotecan/Tegafur in people with Esophageal Cancer, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Lerotinib and Irinotecan/Tegafur
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteChina
- Study dates
- 21 Jan 2021to 30 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Documented objective radiographic or clinical disease progression on two previous lines of standard therapy.
- Can provide archival tumor tissue sample for biomarker analysis (such as EGFR overexpression/expansion status), biopsies are required if tissue samples cannot be provided
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- Confirmed by the central laboratory as EGFR high expression.
- Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
- Ability to swallow drugs.
- Adequate organ function.
- Voluntarily join the study and sign informed consent ad has good compliance.
Who cannot join
- 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.
- Have undergone major surgery within 4 weeks prior to randomization (not including diagnostic surgery) or expect major surgery during the study period.
- 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).
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- Received a live vaccine within 28 days before randomization or plan to receive live vaccine after enrollment.
- 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.
- Simultaneously receiving any other anti-tumor treatment.
- 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。
- 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.
- Clinically obvious gastrointestinal abnormalities, which may affect the intake, transport or absorption of drugs.
- Having active gastrointestinal ulcer, active gastrointestinal bleeding, and perforation;
- Risk of major bleeding or esophageal fistula;
- 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
- 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.
- Has congenital or acquired immune deficiency (such as HIV infection).
- Known active Hepatitis B or C.
- 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.
- 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.
- 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%.
- 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.
- Has uncontrolled pleural effusion, pericardial effusion, pelvic effusion, or ascites requiring repeated drainage.
- Has a history of organ transplantation or a history of allogeneic bone marrow transplantation.
- 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.
- Has other serious acute or chronic diseases and are not suitable for participating in clinical trials judged by investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100036
JianMing Xu, Doctor, 010-66947176 ext. 86, jmxu2003@yahoo.com
About this study
Official title: 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
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.
Read the detailed description
The experimental group and the control group were administered until the disease progression assessed by the RECIST V1.1 standard (unless The investigator evaluates that the subject continues to have clinical benefits, and the subject can be allowed to continue receiving treatment), start new anti-tumor therapy, unacceptable toxicity, withdraw informed consent, ect.
The research phase of this study is divided into screening period, treatment period, treatment end visit, safety follow-up and survival follow-up.
Subjects who have finished the screening examination and evaluation after the screening period enter the treatment period, and evaluate the efficacy. Subjects who have finished the treatment need to continue to undergo safety follow-up ; For subjects who have finished the trial treatment due to toxic reactions or other reasons, and have not observed the progression, they still need to carry out imaging evaluation according to the original frequency until the occurrence of tumor progression judged by RECIST V1.1 standard, start of new anti-tumor therapy, withdrawal of informed consent, loss of follow-up, death, or end of study, whichever occurs first; all subjects receive survival follow-up until death,lost of ,the follow-up or the study ended，whichever occurred first.
PK studies: Pharmacokinetic (PK) studies are conducted only in centers with appropriate conditions. Only some subjects in the experiemtal group are required to undergo a PK study. Participate in intensive PK blood collection (8-12 cases), and participate in sparse PK blood collection (150 cases). Subjects participating in intensive PK blood collection do not participate in sparse PK blood collection.
Biomarker research: Detect EGFR overexpression and amplification research on tumor tissue samples for all subjects and explore the relationship between its efficacy and changes in EGFR overexpression and amplification status before and after treatment.
- Conditions
- Esophageal Cancer
- Being tested
- Lerotinib, Irinotecan/Tegafur
- Keywords
- ESCC;, EGFR overexpression;, Phase 3
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LerotinibDrug
Also called Z650
Specification: 50 mg/capsule and 150 mg/capsule
Irinotecan/TegafurDrug
Also called Irinotecan Hydrochloride Injection/Tegafur Gimeracil Oteracil Potassium Capsule
Irinotecan:Specification: 2mL: 40mg;5mL:0.1g Tegafur:20mg/capsule
| Study group | Role | What they receive |
|---|---|---|
| Lerotinib Arm | Experimental | 350 mg,qd, orally about half an hour after a meal, continuous administration, every 21 days for a treatment cycle. Receives: Drug: Lerotinib |
| Active Comparator Arm | Active comparator | 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. Receives: Drug: Irinotecan/Tegafur |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to approximately 22 months
Secondary outcomes (7)
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.
Measured: up to approximately 22 months
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
Measured: up to approximately 22 months
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
Measured: up to approximately 22 months
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
Measured: up to approximately 22 months
Incidence of Treatment-Emergent Adverse Events
Assessed by Percentage of Participants With Adverse Events during the treatment assessed by NCI CTCAE 5.0
Measured: up to approximately 22 months
Apparent Oral Clearance (CL/F) of Lerotinib
Defined as oral dose clearance
Measured: up to approximately 22 months
Apparent Volume of Distribution (Vd/F) of Lerotinib
Apparent volume of distribution after administration.
Measured: up to approximately 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start21 Jan 2021
- Primary completionAug 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JianMing Xu, Doctor, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415853
- Sponsor's protocol ID
- PCD-DZ650-20-001
- Status last verified
- Sep 2026
- First submitted
- 28 May 2020
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04415853
- Acronym / sponsor ID
- PCD-DZ650-20-001
- Conditions
- Esophageal Cancer
- Keywords
- ESCC;, EGFR overexpression;, Phase 3
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The experimental group and the control group were administered until the disease progression assessed by the RECIST V1.1 standard (unless The investigator evaluates that the subject continues to have clinical benefits, and the subject can be allowed to continue receiving treatment), start new anti-tumor therapy, unacceptable toxicity, withdraw informed consent, ect.
The research phase of this study is divided into screening period, treatment period, treatment end visit, safety follow-up and survival follow-up.
Subjects who have finished the screening examination and evaluation after the screening period enter the treatment period, and evaluate the efficacy. Subjects who have finished the treatment need to continue to undergo safety follow-up ; For subjects who have finished the trial treatment due to toxic reactions or other reasons, and have not observed the progression, they still need to carry out imaging evaluation according to the original frequency until the occurrence of tumor progression judged by RECIST V1.1 standard, start of new anti-tumor therapy, withdrawal of informed consent, loss of follow-up, death, or end of study, whichever occurs first; all subjects receive survival follow-up until death,lost of ,the follow-up or the study ended，whichever occurred first.
PK studies: Pharmacokinetic (PK) studies are conducted only in centers with appropriate conditions. Only some subjects in the experiemtal group are required to undergo a PK study. Participate in intensive PK blood collection (8-12 cases), and participate in sparse PK blood collection (150 cases). Subjects participating in intensive PK blood collection do not participate in sparse PK blood collection.
Biomarker research: Detect EGFR overexpression and amplification research on tumor tissue samples for all subjects and explore the relationship between its efficacy and changes in EGFR overexpression and amplification status before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lerotinib Arm | Experimental | Drug: Lerotinib350 mg,qd, orally about half an hour after a meal, continuous administration, every 21 days for a treatment cycle. |
| Active Comparator Arm | Active comparator | Drug: Irinotecan/TegafurIrinotecan: 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Documented objective radiographic or clinical disease progression on two previous lines of standard therapy.
Key exclusion criteria (26 listed)
- 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.
- Have undergone major surgery within 4 weeks prior to randomization (not including diagnostic surgery) or expect major surgery during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LerotinibAlso: Z650Specification: 50 mg/capsule and 150 mg/capsule | Drug | Lerotinib Arm |
| Irinotecan/TegafurAlso: Irinotecan Hydrochloride Injection/Tegafur Gimeracil Oteracil Potassium CapsuleIrinotecan:Specification: 2mL: 40mg;5mL:0.1g Tegafur:20mg/capsule | Drug | Active Comparator Arm |
Primary outcome
Overall survival
Time frame: up to approximately 22 months
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.
7 secondary outcomes
Progression-free survival
Time frame: up to approximately 22 months
Objective response rate
Time frame: up to approximately 22 months
Duration of response
Time frame: up to approximately 22 months
Changes in health-related quality of life with esophageal cancer symptom scale
Time frame: up to approximately 22 months
Incidence of Treatment-Emergent Adverse Events
Time frame: up to approximately 22 months
Apparent Oral Clearance (CL/F) of Lerotinib
Time frame: up to approximately 22 months
Apparent Volume of Distribution (Vd/F) of Lerotinib
Time frame: up to approximately 22 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
JianMing Xu, Doctor principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lerotinib and Irinotecan/Tegafur in people with Esophageal Cancer, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JianMing Xu, Doctor (010-66939843, jmxu2003@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: up to approximately 22 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.