Papillary Renal Cell Carcinoma Clinical Trial
Official title:
A Multicenter, Open, Prospective Study of Prognostic Value and Benefit From Adjuvant Immunotherapy of Stage III Papillary Renal Cell Carcinoma Based on Multi-classifier System
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 that was successfully categorise patients with stage III pRCC into high-risk and low-risk groups. Here the investigators randomly assign classifier-defined high risk patients of stage III pRCC into adjuvant pembrolizumab group placebo group. Disease-free survival and overall survival are the end points of observation.
Status | Not yet recruiting |
Enrollment | 468 |
Est. completion date | December 1, 2030 |
Est. primary completion date | December 1, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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First Affiliated Hospital, Sun Yat-Sen University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease-free survival | Disease free survival (DFS) was defined as the time interval (in years) from the date of randomization to the first date of recurrence or occurrence of a secondary malignancy or death. | From the date of registration to up to 7 years | |
Secondary | Overall survival | Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. | From the date of registration to up to 7 years |
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