Bladder cancer
Conditions
Interventions
One arm group:Combination of sindilimab (anti-PD-1 antibody) and albumin binding paclitaxel
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Be able to provide written informed consent, understand and agree to comply with the requirements of this study and the evaluation schedule; 2.Male or female, age >= 18 on the date of signing ICF; 3.Histologically diagnosed with inoperable locally advanced or metastatic UC (also known as transitional cell carcinoma or urothelial carcinoma); Including renal pelvis, ureter, bladder and urethra); Patients with a mixed histological type were required to have a histological type dominated by transitional cells; 4.Failure of first-line platinum containing chemotherapy or progress within 12 months; Or platinum containing adjuvant / neoadjuvant therapy relapsed within 12 months; 5.No anti-PD-1 / PD-L1 / CTLA4 was used in the past; 6.There must be lesions (measurable or unmeasurable) that can be evaluated according to RECIST v1.1; Note: a previously irradiated lesion should not be considered as a target lesion unless the lesion has shown disease progression since the last radiotherapy and there is no other lesion to choose as a target lesion; 7.ECOG= 3 months; 9.The patient's organ function was good, which was measured by the following laboratory test values (obtained = 1.5 x 10^9 / L; 2)Platelet >= 100 x 10^9 / L; 3)Hemoglobin >= 90 g / L; (2)International standardized proportion or activated partial thromboplastin time = 120 days after the last administration, and the results of urine or serum pregnancy test are negative within <= 7 days before enrollment. 12.Men who have not been sterilized must be willing to take effective contraceptive measures during the study period and within 120 days after the last administration.
Exclusion criteria
Exclusion criteria: 1.The treatment was targeted at PD-1, PD-L1 and CTLA4; 2.Any approved anti-cancer treatment, including hormone therapy, or any other experimental drug, has been used within 28 days before entering the group or participated in another clinical study for treatment; 3.Within 4 weeks before the group or 5 half-life of the drug, whichever is older, Use systemic immunostimulators (including but not limited to interferon and interleukin-2) for treatment; 4.Active meningeal disease or uncontrolled, untreated brain metastasis. Patients with a history of asymptomatic central nervous system (CNS) metastasis at screening were allowed to be enrolled if all of the following criteria were met: (1)Brain images at screening did not indicate evidence of interim progress; (2)There are measurable lesions other than CNS; (3)Measurable lesions other than CNS did not need to be treated with corticosteroids continuously; Stable dose of anticonvulsant treatment is allowed.No stereotactic radiotherapy within 7 days before entering the group or no whole brain radiotherapy within 14 days before entering the group. 5.Uncontrolled hypercalcemia, defined as one of the following: (1)> 1.5 mmol/l ion calcium; (2)Serum calcium > 3 mmol/l, corrected serum calcium > ULN (if serum albumin is less than 40 g/l); (3)Symptomatic hypercalcemia must be treated with bisphosphonates or denosumab on an ongoing basis; (4)Patients with no clinically significant history of hypercalcemia, if bisphosphonate therapy or dinosemide has been identified to be used to specifically prevent bone events prior to study treatment, the conditions are met. 6.Pleural effusion, pericardial effusion or ascites that need drainage within 2 weeks before the group is included and are clinically uncontrolled; 7.History of active autoimmune disease or autoimmune disease that may recur; Note: Patients with the following diseases do not need to be excluded and further screening can be continued: (1)Well controlled type 1 diabetes; (2)hypothyroidism (only hormone replacement therapy); (3)control of good chylosis; (4)skin diseases without systemic treatment (such as vitiligo, psoriasis Hair loss); (5)any other disease that is not expected to recur without external triggers. 8.Active cancer that does not belong to the specific cancer studied in this study for a period of 10 mg/ day) or other immunosuppressive drugs within 14 days before entering the group; Note: Patients who have used any of the following steroid treatment schemes at present or in the past need not be excluded: (1)Adrenal steroid replacement therapy (dose equivalent to prednisone <=10 mg/ day) is permissible in the absence of active immune disease; (2)Topical, eye, joint, nasal or inhaled corticosteroids, with very low systemic absorption; (3)Short term (< 7 days) preventive use of corticosteroids (e.g. for contrast agent allergies) or for non autoimmune diseases (such as delayed hypersensitivity response caused by contact allergens). 10.Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Overall survival;Health-related quality of life;Incidence of adverse events (AE); | — |
Countries
China
Contacts
Public ContactLin Tianxin
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed