Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer
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- STATUS
- Recruiting
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- End date
- Nov 17, 2022
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- participants needed
- 416
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- sponsor
- Sunshine Lake Pharma Co., Ltd.
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.
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 endedwhichever 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.
Details
| Condition | cancer of the esophagus, oesophageal carcinoma, Head and Neck Cancer, Esophageal Cancer, Esophageal Diseases, esophagus cancer, head and neck cancer, Esophageal Carcinoma, Esophageal Disorders, oesophageal cancer |
|---|---|
| Treatment | Lerotinib, Irinotecan/Tegafur |
| Clinical Study Identifier | NCT04415853 |
| Sponsor | Sunshine Lake Pharma Co., Ltd. |
| Last Modified on | 17 July 2021 |
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