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New treatment option for Esophageal Cancer
Official title Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
ClinicalTrials.gov ID: NCT04415853
What this study is testing
What is Lerotinib?
Lerotinib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for esophageal cancer.
Also referred to as Z650.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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 (people who have entered the follow-up period are...
See the full eligibility criteria
Who can 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
- 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.
What rules you out
- 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...
- 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 (people who have entered the follow-up period are calculated based on the last use of experimental drugs or devices).
- 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...
- 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 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.