Clinical trial · Interventional
Multi-classifier System for Stratifying Stage III Papillary Renal Cell Carcinoma of Receiving Adjuvant Therapy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Papillary Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pembrolizumab
- description
- Participants receive pembrolizumab 200 mg on Day 1 of each 3-week cycle for up to 17 cycles.
- interventionNames
- Drug: Pembrolizumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants receive intravenous placebo on Day 1 of each 3-week cycle for up to 17 cycles.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Disease-free survival
- timeFrame
- From the date of registration to up to 7 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available