Esophageal squamous carcinoma
Conditions
Interventions
Treatment group:Irinotecan Hydrochloride liposome Injection (II) combined with S-1 and Camrelizumab
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Locally advanced, locally recurrent or metastatic esophageal squamous cell carcinoma confirmed by histology or cytology as unresectable; 2. Male or female, aged>=18 years and =12 weeks; 7. The functions of major organs and bone marrow are normal, meeting the following requirements: a. Hematological system function: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count >= 75 x 10^9/L, hemoglobin>=90 g/L b. Adequate renal function: Serum creatinine 40 mL/min (Cockcroft-Gault formula) c. Liver function: Total bilirubin =50%; QTc < 450ms for males and < 470ms for females. 8. Female subjects with fertility need to undergo a serum pregnancy test within 72 hours before the initiation of the study drug administration, with a negative result, and take effective contraceptive measures (such as intrauterine devices, contraceptives or condoms) during the trial and for at least 6 months after the last administration; For male subjects whose partners are fertile women, surgical sterilization should be performed or they should agree to take effective contraceptive measures during the trial and within 6 months after the last administration. 9. The subjects voluntarily joined this study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have received irinotecan treatment in the past; 2. Have received S-1 treatment in the past; 3. Have received immune checkpoint inhibitor treatment in the past (including neoadjuvant therapy, first-line treatment, etc.); 4. There is a third space effusion with clinical symptoms that cannot be controlled by drainage or other methods (such as a large amount of pleural effusion or ascites); 5. Have any active autoimmune diseases or a history of autoimmune diseases (such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituitinitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); Patients with childhood asthma that has been completely relieved and does not require any intervention in adulthood or vitiligo can be included, but those who need medical intervention with bronchodilators cannot be included. 6. Suffering from congenital or acquired immune dysfunction, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA >= 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method), or co-infection with hepatitis B and hepatitis C; 7. Severe infection occurs within 2 weeks before the first medication (e.g., intravenous infusion of antibiotics, antifungal or antiviral drugs is required) 8. Arterial/venous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc. 9. Have suffered from or been accompanied by other systemic malignant tumors within the last five years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix and ovarian cancer. 10. Those who are known to be allergic to any test drug; 11. Pregnant and lactating patients, as well as those with reproductive capacity, are reluctant to take effective contraceptive measures; 12. There is a clear history of neurological or mental disorders in the past, including epilepsy and dementia; 13. Known uncontrollable or symptomatic active central nervous system (CNS) metastases, manifested as the presence of clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal diseases and/or progressive growth; 14. Other circumstances that the researchers consider unsuitable for inclusion. If accompanied by family or social factors, it may affect the safety of the subjects or the collection of data and samples.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival(PFS);Overall survival(OS);Safety; | — |
Countries
China
Contacts
Public ContactWei Huang
Shandong Cancer Hospital and Institute, Shandong First Medical University
Outcome results
None listed