Esophageal squamous cell carcinoma
Conditions
Interventions
test group:Carelizumab combined with apatinib and irinotecan
Sponsors
The First Affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged greater than 18 years, male or female; 2. Diagnosis of esophageal squamous cell carcinoma by histopathology or cytology; 3. Measurable lesions complying with RECIST 1.1 criteria; 4. Previous systemic first-line chemotherapy failed or intolerable; 5. Physical performance score ECOG 0-1; 6. No serious hematopoietic function, heart, lung, liver, kidney function abnormalities and immune deficiency, laboratory tests meet the following requirements: neutrophils >= 1.5 x 10^9 / L; Hemoglobin >= 9g / dL; platelets >= 100 x 10^9 / L; total bilirubin <= 1.5 times the upper limit of normal value; AST (SGOT) and ALT (SGPT) <= 2.5 times the upper limit of normal value; creatinine <= 1.5 times the upper limit of normal value. 7. Subjects voluntarily joined the study, signed informed consent, good compliance, and cooperated with follow-up; 8. Researchers believe that treatment can benefit.
Exclusion criteria
Exclusion criteria: 1. The primary esophageal cancer has a risk of perforating and bleeding, which invades the trachea or adjacent large blood vessels or the heart; 2. Patients who have been proven to be allergic to the test drug and its accessories; 3. The subject has an active immune disease or history, Have a history of organ transplantation; 4. Subjects are being treated with immunosuppressive agents, or systemic or absorbable local hormones for immunosuppressive purposes (dose> 10mg / day prednisone or other curative hormones), and enrolled Continued use within the first 2 weeks, except for the use of toxic hormones produced by radiotherapy and chemotherapy; 5. Have clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure above NYHA level 2; (2) not Stable angina pectoris; (3) Myocardial infarction occurred within 1 year; 6. Pregnant or lactating women; 7. Patients who were unsuitable for inclusion in the study at the judgement of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ProgressionFreeSurvival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| DoR;OverallSurvival, OS;Objectiveresponserate, ORR;DiseaseControlRate, DCR;EORTCQLQ-C30;Adverse events; | — |
Countries
China
Contacts
Public ContactYifu He; Gang Wang
Anhui Cancer Hospital
Outcome results
None listed