To hear about similar clinical trials, please enter your email below
Trial Title:
Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy
NCT ID:
NCT06146777
Condition:
Papillary Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Pembrolizumab
Conditions: Keywords:
Papillary renal cell carcinoma
pembrolizumab
Adjuvant therapy
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Intravenous infusion
Arm group label:
Pembrolizumab
Other name:
KEYTRUDA®
Other name:
MK-3475
Other name:
SCH 900475
Intervention type:
Drug
Intervention name:
Placebo
Description:
Intravenous infusion
Arm group label:
Placebo
Other name:
saline solution
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.
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
December 1, 2023
Completion date:
December 1, 2030
Lead sponsor:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Source:
First Affiliated Hospital, Sun Yat-Sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06146777
