Esophageal squamous cell carcinoma
Conditions
Interventions
Test group:Serplulimab is treated with anlotinib and tezio
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to implementation of any trial-related procedures; 2. Age>=18 years old and 3 months; 10. Adequate organ function, subject must meet the following laboratory indicators: (1) Absolute neutrophil value (ANC) >=1.5×10^9/L without the use of granulocyte colony-stimulating factor in the past 14 days; (2) Platelet >=100×10^9/L without blood transfusion in the past 14 days; (3) Hemoglobin >9g/dL in the absence of blood transfusion or use of erythropoietins in the past 14 days; (4) Total bilirubin =60 ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5× ULN; (8) Euthyroidism, defined as thyroid-stimulating hormone (TSH) within the normal range. If the baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled; (9) Myocardial enzyme profile within the normal range (if the investigator comprehensively judges that the simple laboratory abnormality is not clinically significant, enrollment is also allowed); 11. For female subjects of childbearing potential, a urine or serum pregnancy test with a negative result should be undertaken within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is ordered. Women of non-childbearing age are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy; 12. If there is a risk of conception, all subjects (male or female) must use contraception with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug).
Exclusion criteria
Exclusion criteria: 1. Previous immunotherapy with serplulimab; Previous treatment with anlotinib; Prior chemotherapy with Tigio or 5-FU and progression within six months; 2. Patients with esophageal fistula, esophageography showing sharp corner ulcer, CT showing transmural necrosis, etc. 3. Diagnosis of other malignant diseases other than esophageal squamous cell carcinoma within 5 years prior to the first dose (excluding radical basal cell carcinoma of the skin, cutaneous squamous epithelial carcinoma, and/or radically resected carcinoma in situ); 4. Currently participating in interventional clinical investigational treatment, or receiving other investigational drugs or using investigational devices within 4 weeks prior to the first dose; 5. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered systemic therapy; 6. Is receiving systemic glucocorticoid therapy (excluding topical glucocorticoids by nasal spray, inhaled or other routes) or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study; Note: Physiologic doses of glucocorticoids (<=10 mg/day of prednisone or equivalent) are allowed; 7. Presence of clinically uncontrollable pleural effusion/abdominal effusion (subjects who do not require drainage of effusion or who have stopped drainage for 3 days without significant increase in effusion can be enrolled); 8. Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 9. Known allergy to the active ingredients or excipients of this study drug serplulimab, anlotinib, tegeo, etc.; 10. Has not recovered adequately from toxicity and/or complications caused by any intervention (i.e., <=grade 1 or reached baseline, excluding fatigue or alopecia) prior to starting treatment; 11. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 12. Untreated active hepatitis B (defined as HBsAg positive and concurrent detection of HBV-DNA copy number greater than the upper limit of normal in the laboratory department of the study center); Note: Hepatitis B subjects who meet the following criteria may also be enrolled: (1) HBV viral load < 1000 copies/ml (200 IU/ml) prior to the first dose, and subjects should receive anti-HBV therapy throughout the duration of study chemotherapy drug treatment to avoid viral reactivation (2) Prophylactic anti-HBV therapy is not required for subjects with anti-HBc ( ), HBsAg (-), anti-HBs (-), and HBV viral load (-), but close monitoring of viral reactivation is required 13. Subjects with active HCV infection (positive for HCV antibodies and HCV-RNA levels above the lower limit of detection); 14. Vaccination with a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1); Note: Receipt of an injectable inactivated virus vaccine against seasonal influenza within 30 days prior to the first dose is permitted; However, it is not allowed to receive intranasal live attenuated influenza vaccine; 15. Pregnant or lactating women; 16. Presence of any serious or uncontrollable systemic disease, such as: (1) Resting ECG has significant abnormalities in rhythm, conduction or morphology with severe symptoms that are difficult to control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival, PFS;safety and tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate (ORR);overall survival;Duration of Relief (DOR);Disease Control Rate (DCR); | — |
Countries
China
Contacts
Public ContactWei Huang
Affiliated Cancer Hospital of Shandong First Medical University (Shandong Cancer Prevention and Control Research Institute, Shandong Cancer Hospital)
Outcome results
None listed