Multi-classifier System for Stratifying Stage III Papillary Renal Cell

Status Not yet recruiting

Clinical Trial 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 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.

Clinical Trial 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 distinct histologic features, clinical courses, and responses to therapy. Clear cell renal cell carcinoma (ccRCC) and papillary renal cell carcinoma (pRCC) are the most common histologic subtypes of RCC, accounting for approximately 75% and 20% of all cases, respectively. Adjuvant pembrolizumab showed promising efficacy in ccRCC, however, whether high-risk pRCC patients could benefit from adjuvant pembrolizumab remain unknown. Participants will be assigned to continue with the study treatment until any of the following occurs: the recurrence of the disease; the emergence of unacceptable adverse events (AEs); the presence of an intercurrent illness that precludes further administration of the treatment; the decision of the Investigator to withdraw the participant; noncompliance with the study treatment or procedural mandates; administrative reasons necessitating the discontinuation of treatment; or the completion of 17 treatment cycles (approximately one year), with each cycle 3 weeks long. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06146777
Study type	Interventional
Source	First Affiliated Hospital, Sun Yat-Sen University
Contact	Jun-Hang Luo, M.D.
Phone	+862087755766
Email	luojunh@mail.sysu.edu.cn
Status	Not yet recruiting
Phase	Phase 3
Start date	December 1, 2023
Completion date	December 1, 2030

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms