Actively Recruiting
Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2025-05-18
416
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Histologically or cytologically confirmed esophageal squamous cell carcinoma, advanced or metastatic
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 3 months
- Documented disease progression after two previous lines of standard therapy
- Ability to provide archival tumor tissue or biopsy for biomarker analysis
- Confirmed EGFR high expression by central laboratory
- Measurable disease based on RECIST 1.1 criteria
- Ability to swallow study drugs
- Adequate organ function
- Willingness to voluntarily participate and sign informed consent with good compliance
You will not qualify if you...
- Prior treatment with EGFR targeted drugs including EGFR antibodies
- Previous treatment with Irinotecan or Tegafur
- Use of anthracycline, nitrosourea, mitomycin within 6 weeks; traditional Chinese medicine for anti-tumor within 2 weeks; immune anti-tumor therapy within 8 weeks; or other anti-tumor therapies within 4 weeks before randomization
- Not fully recovered from adverse events of previous treatments
- Major surgery within 4 weeks prior to randomization or planned during the study
- Participation in other clinical trials within 4 weeks before randomization
- Live vaccine use within 28 days before randomization or planned after enrollment
- Use of strong CYP3A4 enzyme inducers or inhibitors within 1 week or Solivudine or similar drugs within 56 days before randomization
- Concurrent use of other anti-tumor treatments
- Additional malignancy within last 5 years except certain cured skin cancers or tumors
- Central nervous system metastasis that is uncontrolled or unstable within 4 weeks after therapy
- Clinically significant gastrointestinal abnormalities affecting drug intake or absorption
- Active gastrointestinal ulcer, bleeding, or perforation
- Risk of major bleeding or esophageal fistula
- History or presence of interstitial lung disease or immunotherapy-associated pneumonia or symptomatic pneumonia
- Active infection requiring intravenous therapy or unexplained fever above 38.5°C within 2 weeks prior to randomization
- Congenital or acquired immune deficiency such as HIV
- Known active Hepatitis B or C
- Certain serious cardiovascular diseases within 12 months before randomization
- Thrombosis or embolism within 12 months before randomization
- QTc interval >470 ms, history of long QT syndrome or significant ventricular arrhythmias, or left ventricular ejection fraction less than 50%
- Allergies or contraindications to study drug ingredients
- Uncontrolled pleural, pericardial, pelvic effusions, or ascites requiring repeated drainage
- History of organ or allogeneic bone marrow transplantation
- Pregnant, breastfeeding, or planning conception during the study period through 6 months after last dose
- Other serious acute or chronic diseases deemed unsuitable for trial participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100036
Actively Recruiting
Research Team
J
JianMing Xu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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