Phase
Condition
Testicular Cancer
Urothelial Cancer
Urologic Cancer
Treatment
Albumin-paclitaxel Injection
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Individuals able to understand and give written informed consent.
Histologically or cytologically confirmed cancer of one of the following types:
PAGET's disease of scrotum with infiltrating sweat gland carcinoma Rhabdomyosarcoma Testicular cancer Penile cancer Urachal cancer
Stage IV disease
Adequate performance status (ECOG 0-2)
Expected survival ≥ 3 months.
Measurable disease by CT or MRI, Or lesions with skin infiltration.
Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL,absolute neutrophil count (ANC) > 1,500 per mm^3, platelets > 100,000 per mm^3).
Adequate renal and hepatic function (creatinine ≤ 2.0 x institutional upper limit ofnormal (IULN), bilirubin ≤ 1.5 IULN, aspartate aminotransferase (AST) and alanineaminotransferase (ALT) ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
Adequate coagulation function: International Normalized Ratio (INR) ≤1.5 /PT≤1.5×ULN, aPTT≤1.5×ULN.
Willing to use a medically approved contraceptive method from the enrollment to atleast 120 days after the end of the study, and sperm donation to another person orcryopreservation for fertilization and reproduction is not permitted during thisperiod.
Ability to comply with research visit schedules and other protocol requirements.
Exclusion
Exclusion Criteria:
- Active or uncontrolled severe infections (≥CTCAE Level 2) requiring systemicantibacterial, antifungal, or antiviral therapy, including tuberculosisinfections.
- Active hepatitis (transaminases not within inclusion criteria; HBV reference:HBV DNA ≥2000 IU/ml or ≥10^4 copies/ml; HCV reference: HCV RNA ≥2000 IU/ml or ≥10^4 copies/ml; after nucleoside antiviral treatment below the abovestandards, may be eligible; chronic HBV carrier with HBV DNA <10^4 IU/ml, mustreceive antiviral treatment during the study period to be eligible).
- Renal failure requiring hemodialysis or peritoneal dialysis.
- History of immunodeficiency, including HIV positive or having otheracquired/congenital immunodeficiency diseases, or organ transplant history.
- Severe nausea, headache, insomnia, fatigue, somnolence, dry mouth, dizziness,and constipation.
- History of active tuberculosis.
- Uncontrolled ascites, pleural effusion, or pericardial effusion requiringrepeated drainage.
- Patients who have undergone major organ transplantation.
- Individuals who have undergone major surgical procedures, open biopsies, orobvious traumatic injuries within 28 days prior to the start of the study; orhave unhealed wounds or fractures for a long time;
- Individuals who have participated or are currently participating in anotherclinical study within the past 4 weeks prior to the start of the study;
- Individuals with a history of severe allergies;
- Individuals at risk of bleeding, or with impaired coagulation function, or whoare currently receiving thrombolytic therapy;
- Individuals with a history of substance abuse with no ability to abstain orwith a mental disorder.
- According to the investigator's judgment, subjects with serious adverse effectson their safety or completion of the study, or those with accompanying diseasesthat seriously endanger the safety of the subjects or affect the completion ofthe study, or those with other reasons deemed unsuitable for enrollment by theinvestigator. Subjects with a history of a clearly defined neurological orpsychiatric disorder, such as dementia, epilepsy, or a history of epilepsyprone.
Study Design
Study Description
Connect with a study center
Fudan University Cancer Hospital
Shanghai, Shanghai 200032
ChinaActive - Recruiting

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