Status:
NOT_YET_RECRUITING
Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Papillary Renal Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The goal of this trial is to test whether patients with stage III papillary renal cell carcinoma (pRCC) could benefit from adjuvant therapy or not. The investigators invented a multi-classifier system...
Detailed Description
kidney cancer represented 4.2% of all new cancer cases, and its incidence has been increasing. Over 90% of kidney cancer cases are renal cell carcinoma (RCC), which includes various subtypes with dist...
Eligibility Criteria
Inclusion
- Histological confirmation of pRCC
- With confirmed diagnosis of stage III pRCC
- Classified as high-risk by multi-classifier system
- With moderate/good Eastern Cooperative Oncology Group (ECOG) health rating (PS): 0-1 score.
- Receive radical operation for renal cancer with negative margin.
- Receive no anti-cancer treatment before primary surgery.
- The informed consent has been obtained from the patient.
Exclusion
- Patients with Transcription factor enhancer 3(TFE3) or transcription factor EB (TFEB) translocation proven by cytogenetic analysis or by fluorescence in situ hybridization (FISH)
- Previously received neoadjuvant therapy
- With severe comorbidities, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes mellitus, and chronic renal dysfunction.
- With bad compliance or contraindication to enrollment.
- Pregnant woman or lactating woman.
- With contraindication to receive pembrolizumab, such as had a prior solid organ transplant, has a known history of human immunodeficiency virus infection.
Key Trial Info
Start Date :
December 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
468 Patients enrolled
Trial Details
Trial ID
NCT06146777
Start Date
December 1 2023
End Date
December 1 2030
Last Update
November 29 2023
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