Status:
UNKNOWN
Pegylated Liposomal Doxorubicin, PD-1 in Treating Muscle Invasive Bladder Cancer
Lead Sponsor:
Tianjin Medical University Second Hospital
Collaborating Sponsors:
CSPC Pharmaceutical Group Limited
Conditions:
Muscle Invasive Bladder Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Despite primary surgical management of muscle invasive bladder cancer (MIBC) with radical cystectomy and pelvic lymphnode dissection, up to 50% of patients will eventually develop tumours at distant s...
Eligibility Criteria
Inclusion
- Clinically confirmed muscle-invasive bladder cancer.
- Histologically confirmed by HE staining or IHC staining.
- Life expectancy of greater than or equal to 3 months.
- KPS performance \>60, ECOG performance status ≤2.
- Adequate liver function with a bilirubin up to 1.5 x ULN. Transaminases up to 2.5 x ULN; for liver metastasis, transaminases up to 5 x ULN.
- Adequate bone marrow function, as defined by neutrophils count of ≥1.5×109/L, platelet count≥80×109/L, hemoglobin≥9.0g/dL.
- Adequate renal function (serum creatinine ≤1.25 times the ULN, and the release rate of which ≥ 60ml/min).
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
- Negative serum pregnancy test for female subjects with reproductive potential =\< 7 days prior to registration, for women of childbearing potential only. All female patients of childbearing age and all male patients with partners of childbearing age should use a reliable method of contraception, such as the barrier method, throughout the study and for 8 weeks after last treatment.
- Sign the informed consent before any trial related activities.
Exclusion
- A prior malignancy, other than non-melanoma skin cancer, carcinoma in situ, localized prostate cancer or ductal carcinoma in situ treated by surgery unless they have completed therapy at least 5 years prior to start of study and have no evidence of recurrent or residual disease
- Chemotherapy, biological therapy or other anti-cancer drugs ≤ 28 days prior to pre-registration
- Factors that would affect taking medicine orally, such as dysphagia, chronic diarrhea and intestinal obstruction
- History of arterial/venous thrombus ≤ 6 months prior to registration, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism
- History or tendency of gastrointestinal hemorrhage caused by severe gastroesophageal varices or other reasons.
- Dysfunction of blood coagulation: prothrombin time (PT)\>16s, activated partial thromboplastin time (APTT) \>43s, thrombin time (TT) \>21s, INR \>2, fibrinogen \< 2g/L, bleeding tendency or under thrombolytic or anticoagulant therapy
- Uncontrolled intercurrent illness including, but not limited to:
- ongoing or active infection; poor controlled diabetes (FBG \> 10 mmol/L); urine protein ≥++, and UAE \> 1.0g/24h; myocardial ischemia; congestive heart failure; cardiac arrhythmia or cardiac insufficiency; LVEF \< 50%
- Unhealed wounds, ulcers or fractures
- Abuse of psychotropic substances or mentally disturbed
- History of HIV, organ transplantation or any other acquired, congenital immunodeficiency diseases
- Patients evaluated not suitable for the study in the opinion of investigators
Key Trial Info
Start Date :
September 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04101812
Start Date
September 17 2019
End Date
May 31 2021
Last Update
September 26 2019
Active Locations (1)
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1
Tianjin Medical Unversity Second Hospital
Tianjin, Tianjin Municipality, China