urological tumours
Conditions
Interventions
A: renal cancer:medical treatment
B: uroepithelial carcinoma:medical treatment
C: mCRPC: medical treatment
Sponsors
Zhongda Hospital Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. All the conditions of any of the following cohorts are met Cohort I: 1) advanced renal cancer (clinical stage IV according to the 8th edition 2017 AJCC TNM staging of renal cancer) diagnosed by pathological histology as inoperable for surgical resection. 2) Patients with recurrence or metastasis after nephrectomy. 3) failure of first-line line TKI therapy and progressive disease requiring second-line therapy. Definition of failure: disease progression during or after the last treatment, or intolerable toxicities during treatment. (Prior neoadjuvant or adjuvant therapy is allowed. Neoadjuvant/adjuvant treatment is considered to be a failure of first-line treatment for progressive disease if disease relapse or progression occurs within 6 months of neoadjuvant/adjuvant treatment) Cohort 2. 1) Advanced inoperable uroepithelial carcinoma (including bladder, ureter, renal pelvis and urethral origin) diagnosed by pathological histology; or recurrent tumour after surgery and failure of first-line chemotherapy. 2) Failed at least 1 platinum-based chemotherapy at advanced stage with progressive disease requiring second-line therapy. Cohort 3. 1) Patients with a histopathologically confirmed diagnosis of mCRPC of the prostate. 2) have received at least 1 failed systemic systemic therapy with progressive disease requiring second-line therapy. 2. patients volunteered to participate in this study, signed an informed consent form and were well complying. 3. an age of 18-80 years. 4. an ECOG score of 0 or 1; an expected survival of not less than 6 months. 5. have at least one measurable lesion (RECIST 1.1) 6. have good function of major organs
Exclusion criteria
Exclusion criteria: Patients with any of the the following condition could not be enrolled in this study. 1. previous treatment with relevant immunotherapeutic agents including anlotinib or against PD-1, PD-L1, etc. 2. have received other antitumour therapy (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks prior to the start of study treatment, or have not recovered from previous toxicity (except 2nd degree alopecia and 1st degree neurotoxicity). 3. co-morbidities/history 1) clinically significant haemoptysis (haemoptysis >50ml per day) within 3 months prior to enrolment; or clinically significant bleeding symptoms or a definite bleeding tendency, e.g. gastrointestinal bleeding, haemorrhagic gastric ulcer, baseline fecal occult blood and above, or vasculitis 2) arteriovenous thrombotic events such as cerebrovascular accident (including temporary ischaemic attack), deep vein thrombosis (except for venous thrombosis caused by venous placement for pre-chemotherapy which has resolved in the judgment of the investigator) and pulmonary embolism which occurred within 6 months prior to enrolment. 3) hypertension that is not well controlled by antihypertensive medication (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg); myocardial infarction, severe/unstable angina, NYHA class 2 or higher cardiac insufficiency, clinically significant supraventricular or ventricular arrhythmias, and symptomatic congestive heart failure within 6 months prior to randomization. 4) Interstitial lung disease, non-infectious pneumonia or uncontrollable systemic disease (e.g. diabetes mellitus, pulmonary fibrosis and acute pneumonia) 5) renal insufficiency: urine routine test suggestive of urine protein = ++ or confirmed 24-hour urine protein amount = 1.0 g 6) history of Live-attenuated vaccines within 28 days prior to the first study dose or anticipated live attenuated vaccination (including COVID-19 vaccination) during the study period 7) Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA = 500 IU/ml; hepatitis C, defined as HCV-RNA above the lower limit of detection of the assay) or co-infection with hepatitis B and C. 8) presence of severe infection within 4 weeks prior to first dose, including but not limited to bacteremia requiring hospitalisation, severe pneumonia, etc.; active infection requiring treatment with systemic antibiotics within 2 weeks prior to first dose or unexplained fever >38.5°C during screening/prior to first dose (fever of oncologic origin may be enrolled as judged by the investigator); active tuberculosis within 1 year prior to dosing evidence of active tuberculosis infection within 1 year prior to dosing. 9) major surgery within 28 days prior to enrollment (tissue biopsies and central venous catheterization via peripheral venous puncture [PICC] or port of infusion (PORT) for diagnostic purposes are permitted). 10) Subjects who have previously received or are preparing to receive an allogeneic bone marrow transplant or solid organ transplant 11) those with peripheral neuropathy = grade 2; patients with active brain metastases, cancerous meningitis, spinal cord compression, or disease of the brain or soft meninges detected by imaging CT or MRI at screening (patients with brain metastases who have completed treatment and are symptomatically stable 14 days prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate;Disease Control Rate;Overall Survival;Safety; | — |
Countries
China
Contacts
Public ContactMing Chen
Zhongda Hospital Southeast University
Outcome results
None listed