Esophageal squamous cell carcinoma
Conditions
Interventions
First line chemotherapy failure group:Camrelizumab: 200mg, D1, ivgtt, q3w Irinotecan: 65 mg / m2, d1,8, ivgtt, q3w
First line PD-1 / PD-L1 treatment failure group:Camrelizumab: 200mg, D1, ivgtt, q3w Irinotecan: 65 mg / m2, d1,8, ivgtt, q3w
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-75 years old, no gender limit; 2.ECOG 0-1; 3.Estimated survival time >= 12 weeks; 4.Histologically or cytologically confirmed locally recurrent or metastatic esophageal squamous cell carcinoma without radical treatment; 5.Patients with previous first-line treatment failure (including chemotherapy failure and disease progression using PD-1); 6.At least one measurable lesion (recist1.1 standard); 7.The main organs and bone marrow functions were basically normal: (1) blood routine examination: white blood cell >= 4.0 x 10^9 /L, neutrophil >= 1.5 x 10^9 / L, platelet >= 100 x 10^9 / L, hemoglobin >= 90 g /L; (2) liver function: total bilirubin 60ml / min; (4) International normalized ratio (INR) = 50%; 8.The subjects volunteered to join the study, signed the informed consent form, had good compliance and cooperated with the follow-up; 9.Female subjects of childbearing age and male subjects whose partners were women of childbearing age agreed to use reliable contraceptive measures (such as abstinence, sterilization, contraceptives, injection of contraceptive medroxyprogesterone or subcutaneous implantation) during the study and within 6 months after the infusion of the study drug.
Exclusion criteria
Exclusion criteria: 1.Other malignancies were diagnosed within 5 years prior to the first use of the study drug, except for cured cervical carcinoma in situ, basal or squamous cell skin cancer, localized prostate cancer undergoing radical surgery, and ductal carcinoma in situ treated by radical surgery; 2.Patients with a high risk of bleeding or fistula due to the obvious invasion of adjacent organs (the great artery or trachea); 3.Patients receiving live / attenuated vaccine within 30 days before the first treatment; 4.There were active bleeding, intestinal perforation or intestinal obstruction; 5.Patients who underwent major surgery within 30 days before the first use of the study drug; 6.Patients who have previously used irinotecan; 7.It is forbidden for patients with severe allergic reaction history of irinotecan, monoclonal antibody,camrelizumab, any component or its excipients; 8.Previous use of PD-1 antibody in patients with intolerance; 9.Patients with uncontrollable cardiac symptoms or diseases, such as: (1) heart failure of NYHA class II or above; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention. 10.Severe or uncontrolled disease or active infection; 11.Renal failure needs hemodialysis or peritoneal dialysis; 12.Patients with central nervous system metastasis; 13.Patients with congenital or acquired immune deficiency (e.g. HIV infection), active hepatitis B (HBV-DNA >= 104 copies / ml) or hepatitis C (hepatitis C antibody positive and HCV-RNA higher than the detection limit of the analytical method); 14.Having any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism and hypothyroidism (hormone replacement therapy can be included after normal hormone replacement therapy); 15.History or evidence of interstitial lung disease or active non infectious pneumonia is known; 16.Pregnant or lactating women; 17.Have a history of mental illness or psychotropic substance abuse; 18.According to the researcher's judgment, there are other factors that may cause the subject to be forced to terminate the study, such as suffering from other serious diseases, requiring combined treatment, serious abnormal laboratory test values, family or social factors, which may affect the safety of the subjects or the collection of experimental data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Disease control rate;Duration of relief;Overall survival; | — |
Countries
China
Contacts
Public ContactYanru Qin
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed