Pegylated Liposomal Doxorubicin PD-1 in Treating Muscle Invasive Bladder Cancer

  • STATUS
    Recruiting
  • days left to enroll
    20
  • participants needed
    60
  • sponsor
    Tianjin Medical University Second Hospital
Updated on 23 January 2021

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 sites, owing to pre-existing disseminated occult micrometastases. The first line treatment for relapse or metastatic MIBC is gemcitabine and cisplatin. After the failure of first line treatment, second line chemotherapy drugs can be chosen from doxorubicin, docetaxel, pemetrexed, etc. This non-randomized, prospective study aims to explore the efficacy and safety of PEGylated liposomal doxorubicin and PD-1 in second line treatment of MIBC.

Details
Condition Muscle Invasive Bladder Cancer
Treatment Pegylated Liposomal Doxorubicin (PLD), PD-1
Clinical Study IdentifierNCT04101812
SponsorTianjin Medical University Second Hospital
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Muscle Invasive Bladder Cancer??
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 1.5109/L, platelet count80109/L, hemoglobin9.0g/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 Criteria

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
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