Metastatic esophageal squamous cell carcinoma
Conditions
Interventions
treatment group:Liposomal irinotecan in combination with S-1
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, male or female 2.An histologically confirmed metastatic esophageal squamous carcinoma with first-line immuno / platinum-containing therapy and disease progression at the metastatic stage, without second-line therapy. 3.Brainless metastases; 4.ECOG PS:0~2; 5.The main organs function normally and meet the following requirements (Within 7 days before starting study treatment): 1)\t Hemoglobin [HB]= 90 g\/L; 2)\t Absolute neutrophil count [ANC]=1.5×109\/L; 3)\t Platelet [PLT]=100×109\/L; 4)\t Serum total bilirubin [TBIL]=1.5 times the upper limit of normal (ULN) ; 5)\t Alanine aminotransferase [ALT], aspartate aminotransferase [AST]50ml\/min (Cockcroft-Gault formula); 6.A woman of childbearing age must have had a negative gestation test within 7 days of inclusion and voluntarily used appropriate contraception during the follow-up period and within 8 weeks of the last administration of the study drug; For men, either surgical sterilization should be performed, or consent should be given to using appropriate methods of contraception during observation and within 8 weeks after the last dose of the study drug; 7.People with good adherence are expected to be able to follow up on efficacy and adverse reactions as required by the programme; 8.Sign an Informed Consent;
Exclusion criteria
Exclusion criteria: 1.Previously received ilitaxel or fluorouracil-based chemotherapy; 2.Having other active malignancies within 5 years or at the same time; 3.Have cardiac clinical symptoms or conditions that are not well controlled, such as: (1) cardiac insufficiency or cardiac ultrasound at level II above the New York Heart Association (NYHA) standard: LVEF (left ventricular scintillal score) 450 ms (male); QTc > 470 ms (female) (QTc interval was calculated by Fridericia formula; If the QTc is abnormal, it can be detected three times in a row at intervals of about 2 minutes, and its mean value is taken; 4.People with high blood pressure who are unable to lower to the normal range with antihypertensive medications (systolic blood pressure = 140 mmHg or diastolic blood pressure of = 90 mmHg) (based on the average BP reading obtained from = 2 measurements) allow the above parameters to be achieved by using antihypertensive treatment. 5.Have active autoimmune disease or a history of autoimmune diseases that may recur; 6.Known to have a history of severe allergies to the study drug; 7.An uncontrollable infection occurs during screening; 8.Other physicians considered unfit for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYue Fan
Zhongshan Hospital, Fudan University
Outcome results
None listed