Trial reportJournal for immunotherapy of cancer2026
Adjuvant penpulimab in very-high risk clear cell renal cell carcinoma: a prospective, non-randomized, controlled phase II trial with integrated plasma multi-omics analyses.
Trial report in Journal for immunotherapy of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- Toward precision adjuvant immunotherapy in high-risk clear cell renal cell carcinoma: integrating plasma multiomics with PD-1 blockade.Journal for immunotherapy of cancer · 2026Article
Corrections and comments
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Authors and funding
16 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposePatients with very-high risk clear cell renal cell carcinoma (ccRCC) remain at substantial risk of recurrence after nephrectomy. However, heterogeneity in benefit from adjuvant immunotherapy observed in the KEYNOTE-564 trial, together with limited prospective data in this population, warrants further investigation.
methodsThis multicenter, prospective, non-randomized, controlled phase II trial enrolled patients with very-high risk ccRCC following nephrectomy. Patients received either adjuvant penpulimab or routine surveillance, with 1:1 propensity score matching (PSM) applied to balance baseline characteristics. The primary endpoint was disease-free survival (DFS), with secondary endpoints including overall survival (OS) and safety. Plasma proteomic and metabolomic profiling was conducted for exploratory analyses.
resultsGiven the non-randomized design, baseline imbalances were addressed by PSM, yielding well-balanced cohorts of 87 patients per group. Adjuvant penpulimab was associated with improved DFS compared with surveillance (HR, 0.37; 95% CI 0.16 to 0.89; p=0.026), whereas OS data remained immature. Consistent with Kaplan-Meier estimates, 1-year (94.25% vs 80.46%) and 2-year (88.68% vs 75.38%) DFS rates favored the penpulimab group (log-rank p=0.026). Penpulimab was generally well tolerated, with most treatment-related adverse events being grade 1-2. Plasma proteomic and metabolomic analyses revealed enrichment of immune response-related pathways in patients without disease progression, with circulating biomarkers associated with DFS.
conclusionsAdjuvant penpulimab was associated with improved DFS and a manageable safety profile in patients with very-high risk ccRCC. Plasma-based biomarkers associated with disease progression may inform postoperative risk stratification and warrant further validation. TRIAL REGISTRATION NUMBER: ChiCTR2200062189.
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