Esophageal squamous cell carcinoma
Conditions
Interventions
Experimental group:Adebelimab injection 1200mg, d1 (first day of administration), q3w (3 weeks as a medication cycle)
Medication until disease progression or intolerance.
Apatinib mesylate: 250mg, qd (administered once daily)
Medication until disease progression or intolerance. Irinotecan: intravenous infusion 60mg/m2, D1, D8, q3W (administered on the first and eighth days, 3 weeks as a medication cycle)
Continuous medication for 4-6 cycles.
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, both male and female; 2. Histologically or cytologically confirmed esophageal squamous cell carcinoma with locally advanced unresectable, local recurrence (local lymphatic metastasis) or distant metastasis; 3. Patients who have progressed or are intolerant to first-line systemic therapy (maintenance therapy progression after first-line systemic therapy can also be included). Concurrent chemoradiotherapy received after recurrence or metastasis is considered as first-line treatment; For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), as outcome during or discontinuation of treatment; 4. At least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST 1.1); 5.ECOG:0~1; 6. Expected survival >= 12 weeks; 7. Blood routine and biochemical indicators meet the following criteria within 7 days before enrollment: a. Hemoglobin >= 90g/L; Absolute neutrophil count (ANC) >= 1.5×109/L; Platelet >= 100×109/L (patients must not have received blood transfusion or growth factor support within 14 days of blood sample collection); b. ALT, AST= 60ml/min/1.73m^2; e. Serum albumin >= 30g/L; f. International normalized ratio (INR) or prothrombin time (PT) = low limit of normal (50%). 9. Women of childbearing potential should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and for 6 months after the end of the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment, and must be non-lactating patients; Men should agree to use contraception during the study and for 6 months after the end of the study period Patients who must use contraception; 10. No serious concomitant disease that makes survival < 5 years; 11. Subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients have any active autoimmune disease or history of autoimmune disease (such as but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient has vitiligo; Those who have completely resolved asthma in childhood and do not need any intervention in adulthood can be included; Asthma patients requiring bronchodilators for medical intervention cannot be included); 2. Patients are using immunosuppressants or systemic hormone therapy to achieve immunosuppressive purposes (dose > 10mg/day prednisone or other equivalent efficacy hormones) and continue to use them within 2 weeks before enrollment; 3. Patients with esophageal squamous cell carcinoma whose primary lesion is active bleeding; 4. Those who have multiple factors that affect oral drugs (such as inability to swallow, after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 5. Patients with brain metastases with symptoms or symptom control time for less than 3 months; 6. Patients with any severe and/or uncontrolled disease, including: patients with unsatisfactory blood pressure control (systolic blood pressure =150 mmHg or diastolic blood pressure =100 mmHg); Suffering from grade I or above myocardial ischemia or myocardial infarction, arrhythmia (including QT interval =480ms) and grade I cardiac insufficiency; Active or uncontrolled serious infection; Liver disease such as decompensated liver disease, active hepatitis B (HBV-DNA=104 copy number/ml or 2000IU/ml) or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the analytical method); Those who showed urine protein = in their urine routine and confirmed that the quantitative > of urine protein in 24 hours was 1.0g; 7. Wounds or fractures that have not healed for a long time; 8. Pulmonary hemorrhage with NCI CTCAE grade > 1 within 4 weeks prior to enrollment; Bleeding from other sites with NCI CTCAE grade >2 within 4 weeks prior to enrollment; Patients with bleeding tendency (such as active gastrointestinal ulcers) or who are being treated with thrombolytic or anticoagulant therapy such as warfarin, heparin, or their analogues; 9. Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 10. Patients whose imaging shows that the tumor has invaded important blood vessels or the investigator judges that the tumor is very likely to invade important blood vessels during the subsequent study period, causing fatal major bleeding; 11. Pregnant or lactating women; 12. Patients with other malignant tumors within 5 years (except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); 13. Patients with a history of psychotropic substance abuse who cannot abstain or have mental disorders; 14. Patients who have participated in clinical trials of other drugs within four weeks; 15. Patients with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study according to the judgment of the investigator; 16. Those who are considered unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Median overall survival;Objective remission rate;Disease remission rate;Duration of remission;security; | — |
Countries
China
Contacts
Public ContactZhiwei Chang
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed