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

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ClinicalTrials.gov Identifier: NCT06146777
Recruitment Status : Not yet recruiting
First Posted : November 27, 2023
Last Update Posted : November 29, 2023
Sponsor:
Information provided by (Responsible Party):
Jun-Hang Luo, First Affiliated Hospital, Sun Yat-Sen University

Study Description
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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 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.

Condition or disease Intervention/treatment Phase
Papillary Renal Cell Carcinoma Drug: Pembrolizumab Drug: Placebo Phase 3

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 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 1, 2023
Estimated Primary Completion Date : December 1, 2030
Estimated Study Completion Date : December 1, 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Pembrolizumab
Participants receive pembrolizumab 200 mg on Day 1 of each 3-week cycle for up to 17 cycles.
 Drug: Pembrolizumab
Intravenous infusion
Other Names:
  • KEYTRUDA®
  • MK-3475
  • SCH 900475
Placebo Comparator: Placebo
Participants receive intravenous placebo on Day 1 of each 3-week cycle for up to 17 cycles.
 Drug: Placebo
Intravenous infusion
Other Name: saline solution


Outcome Measures
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Primary Outcome Measures :
  1. Disease-free survival [ Time Frame: From the date of registration to up to 7 years ]
    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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From the date of registration to up to 7 years ]
    Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06146777


Contacts
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Contact: Jun-Hang Luo, M.D. +862087755766 luojunh@mail.sysu.edu.cn

Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Principal Investigator: Jun-Hang Luo, M.D. First Affiliated Hospital, Sun Yat-Sen University
More Information
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Responsible Party: Jun-Hang Luo, Professor, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT06146777    
Other Study ID Numbers: FirstSunYatSen20231101
First Posted: November 27, 2023    Key Record Dates
Last Update Posted: November 29, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jun-Hang Luo, First Affiliated Hospital, Sun Yat-Sen University:
Papillary renal cell carcinoma
pembrolizumab
Adjuvant therapy
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
 Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action