Trial reportBMC medicine2026
Evaluation and analysis of renal injury in patients with advanced renal cell carcinoma receiving first-line benmelstobart plus anlotinib: results from the ETER100 study.
Trial report in BMC medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04523272 (A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer), which is not on this map. Not yet cited in PubMed.
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A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer
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13 authors.
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Abstract
backgroundCombination treatment with anti-angiogenic agents and immune checkpoint inhibitors has demonstrated significant efficacy in advanced renal cell carcinoma (RCC). However, data on treatment-emergent renal injury during combination therapy and its prognostic implications remain limited. This study analyzed renal injury and its association with survival outcomes in patients with advanced RCC receiving first-line benmelstobart combined with anlotinib in the ETER100 trial.
methodsAll randomized patients in the ETER100 (NCT04523272) trial treated with at least one dose of study treatment were included in this analysis. Baseline characteristics, laboratory test results, and information on objective responses, disease progression, and death events were collected. The primary outcomes of this study included renal function changes during therapy, risk factors for renal function abnormalities, clinical outcomes of patients with renal function abnormalities, and the association between renal function abnormalities and survival outcomes.
resultsCompared with sunitinib monotherapy, patients receiving benmelstobart combined with anlotinib showed no significant differences in the incidence of serum creatinine elevation (p = 0.0538), percentage decrease in creatinine clearance (p = 0.2546), absolute decrease in creatinine clearance (p = 0.7343), or proteinuria (p = 0.0728). Multivariate analysis identified a history of nephrectomy and estimated glomerular filtration rate <90 mL/min/1.73 m² as independent predictors of serum creatinine elevation in patients receiving combination therapy. As of January 2024, 64.00% of patients (64/100) who developed serum creatinine elevation during combination therapy had recovered to normal levels, and 6.00% (6/100) showed improvement. Besides, 45.56% of patients (77/169) who had proteinuria recovered to normal, and 22.49% (38/169) experienced improvement. Multivariate Cox regression analysis showed that both serum creatinine elevation (progression-free survival [PFS]: p = 0.3526; overall survival [OS]: p = 0.0521) and proteinuria (PFS: p = 0.5831; OS: p = 0.1224) were not independent risk factors for progression-free survival or overall survival in patients receiving combination therapy.
conclusionsFor patients with advanced RCC in the ETER100 trial, combination therapy with anti-angiogenic agents and immune checkpoint inhibitors did not increase the risk of renal injury, and in this treatment context, renal function abnormalities occurring during treatment were not significantly associated with survival outcomes.
trial registrationClinicalTrials.gov identifier: NCT04523272.
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