A Phase 2 interventional study of Modified Zhixiao Tongmai Ning and Standard Radiotherapy Alone in Cancer Patients Receiving Radiotherapy for Kidney Malignancies, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Peking University First Hospital · Phase 2, Interventional, and Treatment
This prospective randomized controlled study evaluates the clinical efficacy of modified Zhixiao Tongmai Ning in preventing radiation-induced kidney injury in cancer patients. We will assess improvements using routine lab indicators (e.g., glomerular filtration rate, serum creatinine, urine tests), Traditional Chinese Medicine (TCM) syndrome criteria, patient-reported scores, and renal dynamic imaging. The study aims to identify the most suitable patient subgroups and optimal timing for drug use by analyzing baseline factors, radiation parameters, and concurrent treatments, thereby optimizing the formula. Additionally, we will collect blood and urine samples to explore potential mechanisms, focusing on inflammatory factors like TNF-α and IL-6, to support future basic research and clinical application.
This prospective randomized controlled trial comprehensively evaluates the efficacy of modified Zhixiao Tongmai Ning for preventing radiation-induced kidney injury. Assessments combine routine labs (GFR, creatinine, urinalysis), TCM syndrome criteria, patient-reported scores, and pioneering renal dynamic bilateral renal function imaging for precise multi-dimensional evaluation.
Subgroup analyses based on baseline factors (age, gender, renal function, comorbidities), radiotherapy parameters (fractionation, DVH), and anti-tumor treatments will identify optimal patient subgroups and drug timing, supporting formula optimization and component purification.
Additionally, pre- and post-treatment blood and urine samples will be collected to analyze pro-inflammatory cytokines (TNF-α, IL-6). This explores the heat-clearing and Yin-nourishing mechanism against radiation injury, establishing a basis for future animal models and deep mechanistic research.
Exclusion Criteria:
Drug: Modified Zhixiao Tongmai Ning
Drug: Standard Radiotherapy Alone
Patients will receive modified Zhixiao Tongmai Ning (a Traditional Chinese Medicine formula for clearing heat and nourishing Yin) orally, twice daily, throughout the course of radiotherapy and the follow-up period. The administration is combined with kidney-sparing radical radiotherapy for renal malignancies. The specific dosage will be adjusted based on individual TCM syndrome differentiation and clinical condition.
Patients will receive standard care or a matching placebo orally, twice daily, throughout the course of radiotherapy and the follow-up period, combined with the same kidney-sparing radical radiotherapy for renal malignancies.
Incidence of Radiation-Induced Kidney Injury
Assessment of radiation-induced kidney injury (radiation nephropathy) based on the decline in estimated glomerular filtration rate (eGFR) and serum creatinine levels compared to baseline, or clinical diagnostic criteria (e.g., RTOG/EORTC criteria). Evaluated at baseline, end of radiotherapy, and during follow-up visits.
Time frame: From baseline to 6 months after the completion of radiotherapy
Changes in Serum Creatinine and eGFR
Measurement of serum creatinine levels and estimated glomerular filtration rate (eGFR) changes from baseline compared between the two groups.
Time frame: From baseline to 6 months after completion of radiotherapy
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Peking University First Hospital