Cancer Patients Receiving Radiotherapy for Kidney MalignanciesPhase 2NCT07849088
Efficacy Evaluation of Modified Zhixiao Tongmai Ning in Preventing Radiation-Induced Kidney Injury
A Phase 2 study testing Modified Zhixiao Tongmai Ning and Standard Radiotherapy Alone in people with Cancer Patients Receiving Radiotherapy for Kidney Malignancies, run by Peking University First Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients Receiving Radiotherapy for Kidney Malignancies
- What is being tested?
- Modified Zhixiao Tongmai Ning and Standard Radiotherapy Alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 11 Aug 2026to 1 Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or clinically confirmed renal malignancy scheduled to receive kidney-sparing radical radiotherapy.
- Baseline estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m² and serum creatinine within normal limits.
- Expected survival of at least 6 months and able to comply with the study protocol and follow-up visits.
- Provision of written informed consent prior to any study-related procedures.
Who cannot join
- Pre-existing severe renal impairment (e.g., estimated glomerular filtration rate [eGFR] < 60 mL/min/1.73 m²) or history of renal failure.
- Known allergy or hypersensitivity to any components of Zhixiao Tongmai Ning or other Traditional Chinese Medicine herbs.
- Previous treatment with nephrotoxic agents within 4 weeks prior to enrollment, or bilateral renal involvement making kidney-sparing radiotherapy unfeasible.
- Presence of severe uncontrolled systemic diseases (e.g., severe cardiovascular disease, active infection) or expected survival of less than 6 moPregnant or breastfeeding women, or patients with poor compliance who are unable to complete the required follow-up visits.nths.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Radiotherapy Oncology, Peking University First Hospital
Beijing, Beijing Municipality, 100034
Xiao ying Li, MD, +86-13716109164, 13716109164@139.com
About this study
Official title: Efficacy Evaluation of Modified Zhixiao Tongmai Ning in Preventing Radiation-Induced Kidney Injury in Cancer Patients
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.
Read the detailed description
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.
- Being tested
- Modified Zhixiao Tongmai Ning, Standard Radiotherapy Alone
- Keywords
- Modified Zhixiao Tongmai Ning, Radiation-Induced Kidney Injury, Randomized Controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Zhixiao Tongmai NingDrug
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.
Standard Radiotherapy AloneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Modified Zhixiao Tongmai Ning + Radiotherapy | Experimental | Not described Receives: Drug: Modified Zhixiao Tongmai Ning |
| Standard Radiotherapy Alone | Active comparator | Not described Receives: Drug: Standard Radiotherapy Alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 6 months after the completion of radiotherapy
Secondary outcomes (1)
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.
Measured: From baseline to 6 months after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start11 Aug 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients Receiving Radiotherapy for Kidney MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07849088
- Sponsor's protocol ID
- TCM
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes