Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer (NCT04415853) | Clinical Trial Compass
RecruitingPhase 3
Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
China416 participantsStarted 2021-01-21
Plain-language 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 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Prior therapies with EGFR targeted drugs including EGFR antibodies.
✕. 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).
✕. 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.