Status:
UNKNOWN
Neoadjuvant PD-1 Monoclonal Antibody Plus Cisplatin-based Chemotherapy in Locally Advanced Upper Tract Urothelial Carcinoma
Lead Sponsor:
RenJi Hospital
Conditions:
Neoadjuvant Therapy of Locally Advanced Upper Urinary Tract Urothelial Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is designed prospectively to investigate the safety and efficacy of neoadjuvant PD-1 monoclonal antibody combined with cisplatin-based chemotherapy in patients with locally advanced upper u...
Detailed Description
Neoadjuvant therapy of cisplatin-based chemotherapy has been proved to improve prognosis of muscle invasive UTUC patients in several studies. This study is designed to investigate the safety and effic...
Eligibility Criteria
Inclusion
- 1\. Patients that are identified as locally advanced upper urinary tract urothelial carcinoma by ureteroscopic biopsy and imaging diagnosis and are determined as appropriate candidates for radical nephrectomy by an attending urologist; 2. Patients who have a clinical stage of T3-T4, any N, M0 or any T, N1-2, M0; 3. ECOG performance status of 0 to 2; 4. Adequate organ function defined by study-specified laboratory tests;
- Hemoglobin ≥90 g/L;
- Hematological Absolute neutrophil count (ANC) ≥1.5×109 /L;
- Platelets ≥100×109 /L 5. No functional organic disease: T-BIL≤1.5×upper limit of normal (ULN); ALT and AST≤2.5×ULN；eGFR ≥ 60ml/min (MdRD) 6. Agree to comply with scheduled visits, treatment plans, lab tests and any other required study procedures;
Exclusion
- Patients who has received prior therapy of an anti-PD-1, anti-PD-L1, or anti-PD-L2 antibody;
- Patients who are allergic to monoclonal antibodies or any of its excipients;
- Patients who have received other anti-tumor treatment (e. g., Steroid therapy, immunotherapy) within 4 weeks or enrolled in other clinical trials;
- Patients who are pregnant or breastfeeding, or expecting to conceive;
- Patients who have a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies);
- Patients who have known active Hepatitis B or Hepatitis C;
- Patients who have active autoimmune disease that has required systemic treatment in the past 2 years;
- Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment;
- Patients who have received prior radiation therapy to the bladder;
- Patients who have bladder cancer;
- Patients who have received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Patients who have a history of substance abuse or with a history of mental disorders;
- Patients who had other malignant tumors in the past five years that have not recovered except for curable tumors that have been cured including basal or squamous skin cancer, localized carcinoma in situ of the cervix or the breast or low-risk prostate cancer, etc;Patients who have active tuberculosis;
- Patients who have other serious and uncontrollable accompanying diseases that may affect compliance or interfere with the interpretation of results including active opportunistic infections or advanced (severe) infections, uncontrollable diabetes, cardiovascular disease (grade III or IV heart failure defined by the New York Heart Association classification, II degree atrioventricular block and above, myocardial infarction in the past 6 months, unstable arrhythmia or instability angina, cerebral infarction within 3 months, etc.) or lung disease (interstitial pneumonia, history of obstructive lung disease and symptomatic bronchospasm);
- Patients who have a large amount of pleural fluid or ascites with clinical symptoms or requiring symptomatic treatment.
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04672317
Start Date
December 10 2020
End Date
June 1 2022
Last Update
December 17 2020
Active Locations (1)
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1
Shanghai Renji Hospital
Shanghai, Shanghai Municipality, China, 200127