Esophageal cancer
Conditions
Interventions
Experimental group:Sindhilimab+Albumin Taxol
Sponsors
Shandong First Medical University Affiliated Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign the written informed consent before implementing any test related process; 2. Aged 18-75 years, regardless of gender; 3. Advanced or metastatic esophageal squamous cell carcinoma confirmed by histopathology and imaging examination; 4. According to the evaluation standard of solid tumor curative effect (RECIST 1.1), there is at least one imaging measurable lesion; 5. Failures due to intolerance or progression or recurrence after receiving first-line standard treatment for advanced/metastatic diseases in the past; 6. The patients with brain metastasis without symptoms or with stable symptoms after local treatment are allowed to be included in the group. The patients must meet the following conditions: (1) Measurable lesions outside the central nervous system; (2) No symptoms of central nervous system or no aggravation within at least 2 months; (3) Those who do not need glucocorticoid treatment or discontinue glucocorticoid treatment within 3 days before the first study drug administration; 7. ECOG score 0-1; 8. Expected survival time>3 months; 9. Sufficient organ function, patient shall meet the following laboratory indicators: (1) Absolute neutrophil count (ANC) >= 1.5x10 ^ 9/L without granulocyte colony-stimulating factor in recent 14 days; (2) Without blood transfusion in recent 14 days, platelet >= 100 x 10^9/L; (3) Hemoglobin>9g/dL without blood transfusion or use of erythropoietin in the last 14 days; (4) Total bilirubin = 60ml/min; (7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <= 1.5 times ULN; (8) Normal thyroid function is defined as thyroid stimulating hormone (TSH) within normal range. If the baseline TSH is beyond the normal range, the patients whose total T3 (or FT3) and FT4 are within the normal range can also be included in the group; (9) Myocardial zymogram is within the normal range (if the researchers comprehensively judge that the simple laboratory abnormality has no clinical significance, it can also be included in the group); 10. Female patients of childbearing age should receive urine or serum pregnancy test within 3 days before receiving the first study drug administration (the first day of the first cycle) and the result is negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non childbearing age are defined as those who have had at least one year after menopause, or who have undergone surgical sterilization or hysterectomy; 11. If there is a risk of pregnancy, all patients (male or female) should use contraceptives with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).
Exclusion criteria
Exclusion criteria: 1. It is known that the obstruction tends to be complete under endoscope and needs interventional treatment to relieve the obstruction; 2. After esophageal or tracheal stent implantation; 3. Subjects with high risk of bleeding or perforation due to obvious invasion of tumors into adjacent organs of esophageal lesions (large arteries or trachea), or subjects with fistula; 4. Other malignant diseases (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or carcinoma in situ after radical resection) diagnosed within 3 years before the first administration; 5. Currently participating in the intervention clinical research treatment, or receiving other research drugs or using research instruments within 4 weeks before the first administration; 6. Have received the following therapies in the past: anti PD-1, anti PD-L1 or anti PD-L2 drugs or drugs targeting another kind of stimulation or synergistic inhibition of T cell receptors (such as CTLA-4, OX-40, CD137); 7. Have used albumin taxol or other taxanes in the past, including but not limited to taxol, docetaxel, etc; 8. Within 2 weeks before the first administration, he has received systematic systemic treatment with Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion); 9. Active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Alternative therapy (such as thyroxine, insulin or physiological glucocorticoid for adrenal or pituitary insufficiency) is not considered as systemic therapy; 10. The study was receiving systemic glucocorticoid treatment (excluding local glucocorticoids by nasal spray, inhalation or other means) or any other form of immunosuppressive therapy within 7 days before the first administration; Note: It is allowed to use glucocorticoid with physiological dose (prednisone <= 10mg/day or equivalent); 11.Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. Subjects who are known to be allergic to the active ingredient or excipient of the drug in this study, cindilimab, albumin paclitaxel; 13. Before starting the treatment, the subject has not fully recovered from the toxicity and/or complications caused by any intervention (i.e. <= Level 1 or reaching the baseline, excluding fatigue or hair loss); 14. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); 15. Active hepatitis B without treatment (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); Note: Hepatitis B subjects meeting the following criteria can also be included in the group: (1) Before the first administration, the HBV viral load was less than 1000 copies/ml (200IU/ml), and the subjects should receive anti HBV treatment during the whole study chemotherapy treatment to avoid virus reactivation; (2) For subjects with anti HBc (+), HBsAg (-), anti HBs (-) and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored; 16. Subjects with active HCV infection (HCV antibody positive and HCV RNA level higher than the lower limit of detection);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival;Disease control rate;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactNiu Zuoxing
Shandong First Medical University Affiliated Provincial Cancer Hospital
Outcome results
None listed