Advanced Urothelial Carcinoma
Conditions
Interventions
Advanced Urothelial Carcinoma:Radiotherapy for metastatic lesions
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign a written informed consent before implementing any trial-related procedures. 2. Male or female, aged >=18 years and =1.5×10^9/L within 14 days without the use of granulocyte colony-stimulating factor. 2) Platelet count >=100×10^9/L within 14 days without blood transfusion. 3) Hemoglobin >9g/dL within 14 days without blood transfusion or the use of erythropoietin. 4) Total bilirubin =60 ml/min. 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN. 8) Normal thyroid function, 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 are also eligible. 9) Normal myocardial enzyme spectrum (subjects with non-clinically significant isolated laboratory abnormalities as determined by the investigator are also eligible). 8. For female subjects of childbearing age, a urine or serum pregnancy test must be negative within 3 days before the first administration of the study drug (day 1 of cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non-childbearing age females are defined as those who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy. 9. If there is a risk of pregnancy, all subjects (regardless of gender) must use a contraceptive method with a failure rate of less than 1% per year throughout the treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy).
Exclusion criteria
Exclusion criteria: 1. Histological or cytological pathology confirmed as other pathological types, such as neuroendocrine carcinoma, squamous cell carcinoma, sarcoma, etc. 2. Diagnosed with other malignant diseases other than urothelial carcinoma within 3 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and/or in situ carcinoma that have been radically resected). 3. Received palliative local treatment for non-target lesions within 2 weeks before the first administration; received non-specific immunomodulatory treatment (such as interleukin, interferon, thymosin, etc., excluding IL-11 used for treating thrombocytopenia) within 2 weeks before the first administration; received traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first administration. 4. Intracranial metastasis. 5. Target lesions have received high-dose radiotherapy in the past and the tumor is not controlled or the target lesions are not suitable for radiotherapy (such as target lesions invading the intestine, penetrating the bronchus, etc.). 6. Presence of uncontrollable malignant pleural or peritoneal effusion. 7. A clear history of mental illness that hinders the understanding of informed consent and compliance with the study protocol, or other serious diseases that may bring significant risks or affect radiotherapy. 8. Pregnant or lactating women, or women planning to become pregnant during the study. 9. Had active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, glucocorticoids, or immunosuppressants) within 2 years before the first administration. Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids for adrenal or pituitary insufficiency) are not considered systemic treatment. 10. Received systemic glucocorticoid treatment (excluding nasal sprays, inhalation, or other local glucocorticoids) or any other form of immunosuppressive therapy within 7 days before the first administration of the study. Note: Use of physiological doses of glucocorticoids (=10 mg/day of prednisone or equivalent drugs) is allowed. 11. Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 12. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibodies). 13. Untreated active hepatitis B (defined as positive for HBsAg and HBV-DNA copy number greater than the upper limit of normal in the laboratory of the research center). Note: Hepatitis B subjects meeting the following criteria may also be enrolled: 1) HBV viral load <1000 copies/ml (200 IU/ml) before the first administration, and the subject should receive anti-HBV treatment throughout the chemotherapy drug treatment period to prevent viral reactivation. 2) For subjects with positive anti-HBc, negative HBsAg, negative anti-HBs, and negative HBV viral load, no preventive anti-HBV treatment is required, but close monitoring of viral reactivation is necessary. 14. Subjects with active HCV infection (positive for HCV antibodies and HCV-RNA level above the detection limit). 15. Presence of any severe or uncontrollable systemic diseases, such as: 1) Major and symptomatic severe and uncontrollable abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher cardiac conduction bloc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Objective Response Rate;Disease Control Rate;Local Control Rate;Progression Free Survival 2;Duration of Responce;Safety;Disease Control Rate;HER2 expression in tumor tissues;PD-L1 expression in tumor tissues; | — |
Countries
China
Contacts
Public ContactYali Shen
West China Hospital of Sichuan University
Outcome results
None listed