Upper Tract Urothelial Carcinoma Receiving Kidney-sparing TherapyNCT07504939
Multimodal Kidney-Sparing Strategy for High-Risk Upper Tract Urothelial Carcinoma
An observational study of Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy and Upper Tract Urothelial Carcinoma, run by Peking University First Hospital at 1 site in China.
Trial summary
UTUC is a cancer that develops in the lining of the kidney or ureter. The standard treatment is radical nephroureterectomy, which removes the kidney and ureter. Although this surgery can control the cancer, it permanently reduces kidney function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy, Upper Tract Urothelial Carcinoma
- What is being tested?
- SBRT
- Type of treatment
- Surgery or procedure
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with clinically histologically confirmed high-risk upper tract urothelial carcinoma who are evaluated and treated at Peking University First Hospital and participating centers will be screened for eligibility. Participants who meet the inclusion criteria and provide informed consent will be enrolled in the kidney-sparing treatment cohort or the radical nephroureterectomy cohort according to clinical decision-making and treatment preference.
Who may be able to join
- Participants must meet all of the following criteria:
- Age 18 years or older Voluntary participation with written informed consent Pathology indicating upper tract urothelial carcinoma with HER2 at least 1+ expression Clinical stage cT1-T2N0M0 based on imaging evaluation Classified as high-risk upper tract urothelial carcinoma according to European Association of Urology (EAU) criteria Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Adequate renal function with split renal function of the affected kidney ≥10 mL/min on renal dynamic scintigraphy Expected life expectancy greater than 24 months Ability and willingness to comply with study procedures and follow-up schedule Exclusion Criteria
- Participants will be excluded if any of the following conditions are present:
- Inability to tolerate or refusal of kidney-sparing treatment Evidence of advanced disease (≥T3), lymph node metastasis, or distant metastasis Synchronous bladder urothelial carcinoma or other urological malignancies Previous systemic anticancer therapy, including chemotherapy, targeted therapy, immunotherapy, or antibody-drug conjugates Prior radiotherapy involving the urinary tract or retroperitoneal region Severe uncontrolled comorbidities such as cardiovascular, pulmonary, neurological, psychiatric, or systemic diseases Active severe infections requiring systemic antimicrobial therapy Known immune-related disorders requiring long-term immunosuppressive treatment Pregnancy or breastfeeding Known allergy to investigational drugs used in this study Concurrent participation in another therapeutic clinical trial Indeterminate postoperative pathological diagnosis
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating a Kidney-sparing Strategy Combining Endoscopic Surgery, Adjuvant Radiotherapy, and HER2-targeted Antibody-Drug Conjugate in High-risk Upper Tract Urothelial Carcinoma: Study Protocol for a Prospective, Multicenter, Non-randomized Comparative Clinical Trial
UTUC is a cancer that develops in the lining of the kidney or ureter. The standard treatment is radical nephroureterectomy, which removes the kidney and ureter. Although this surgery can control the cancer, it permanently reduces kidney function.
Endoscopic treatment can serve as a kidney-sparing approach for low-risk UTUC; however, in high-risk patients, the high rate of upper tract local recurrence after endoscopic treatment remains the primary failure pattern. This study aims to evaluate the efficacy and safety of radiotherapy-involved kidney-sparing treatment for UTUC.
Read more
The main questions this study aims to answer are: Can this multimodal kidney-sparing strategy reduce local recurrence of UTUC compared with endoscopic treatment alone? Participants in the kidney-sparing group will: Undergo endoscopic surgery to remove the tumor; Receive systemic therapy with disitamab vedotin and toripalimab; Receive targeted radiotherapy after surgery.
Participants will undergo regular follow-up visits, including imaging examinations and endoscopic evaluations, to monitor for recurrence or disease progression.
The results of this study may help determine whether a multimodal kidney-sparing treatment strategy could become a safe and effective option for selected patients with high-risk UTUC.
Read the detailed description
Upper tract urothelial carcinoma (UTUC) is an uncommon malignancy arising from the urothelial lining of the renal pelvis or ureter. Radical nephroureterectomy (RNU) remains the standard treatment for high-risk disease. However, removal of the entire kidney and ureter leads to permanent loss of renal function and may negatively affect long-term quality of life and eligibility for future systemic therapies. Although kidney-sparing treatment is well established for low-risk UTUC, its role in patients with high-risk disease remains uncertain.
Recent advances in systemic therapy and radiotherapy have created opportunities to explore multimodal treatment strategies aimed at improving oncological control while preserving renal function. HER2 expression appears to be relatively frequent in UTUC, and HER2-targeted antibody-drug conjugates such as disitamab vedotin have demonstrated promising activity in urothelial carcinoma. In addition, immune checkpoint inhibitors have improved outcomes in advanced urothelial malignancies. Radiotherapy has also been reported to improve locoregional tumor control in selected patients. These developments provide the rationale for integrating endoscopic tumor management with systemic therapy and selective radiotherapy as part of a comprehensive kidney-sparing strategy.
This prospective multicenter study is designed to evaluate the feasibility, safety, and preliminary oncological outcomes of a multimodal kidney-sparing treatment pathway in patients with high-risk UTUC.
The findings of this study are expected to provide prospective evidence regarding the feasibility of a multimodal kidney-sparing strategy for selected patients with high-risk UTUC and may inform the design of future confirmatory clinical trials.
Sample size considerations Given the low incidence of UTUC and the fact that kidney-sparing treatment has not yet been established as a standard-of-care for high-risk disease, the sample size calculation was primarily based on a benchmark comparison against previously published outcomes from kidney-sparing treatment cohorts. According to available literature, the reported 1-year DFS rate following endoscopic tumor ablation combined with systemic therapy was approximately 58.82% [Chen Z, Ye J, Tu X, et al. Comprehensive modalities of kidney-sparing treatment in a carefully selected cohort of localized high-risk upper tract urothelial carcinoma: a potential paradigm shift. J Clin Oncol. 2025;43(5_suppl):794-794. doi:10.1200/JCO.2025.43.5_suppl.794]. In this study, we hypothesized that the incorporation of radiotherapy into a comprehensive kidney-sparing strategy would increase the 1-year DFS to 85%. Assuming a two-sided significance level of 0.05 and a statistical power of 80%, and accounting for a 20% dropout rate due to potential loss to follow-up and pathological heterogeneity at enrollment, the required sample size was estimated at 36 patients in the kidney-sparing group.
- Conditions
- Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy, Upper Tract Urothelial Carcinoma
- Being tested
- SBRT
- Keywords
- UTUC, Kidney-Sparing Surgery, Endoscopic Treatment, Disitamab Vedotin, Toripalimab, HER2-Targeted Therapy, Radiotherapy, Multimodal Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SBRTRadiation
Participants without confirmed complete tumor resection will receive selective hypofractionated radiotherapy approximately one month after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Kidney-Sparing Multimodal Treatment | Participants undergo endoscopic tumor ablation or resection using thulium fiber laser techniques. Participants without confirmed complete tumor resection will receive selective hypofractionated radiotherapy approximately one month after surgery.Postoperative systemic therapy consists of disitamab vedotin administered every three weeks for eight cycles combined with toripalimab administered every three weeks for up to one year. Receives: Radiation: SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-Year Disease-Free Survival
Disease-free survival is defined as the proportion of participants who remain alive without evidence of local recurrence, upper urinary tract recurrence, intravesical recurrence, disease progression, or distant metastasis.
Measured: 12 months after surgery
One-Year kidney-sparing rate
One-Year kidney-sparing rate is defined as the proportion of participants who do not require conversion to radical nephroureterectomy due to disease progression after initial kidney-sparing treatment.
Measured: 12 months after surgery
Secondary outcomes (6)
Overall Survival
Overall survival is defined as the time from surgery to death from any cause.
Measured: Up to 5 years
Progression-Free Survival
Progression-free survival is defined as the time from surgery to disease progression or death from any cause.
Measured: Up to 5 years
Local Recurrence-Free Survival
Time from surgery to detection of tumor recurrence at the primary surgical site confirmed by ureteroscopic evaluation.
Measured: Up to 5 years
Intravesical Recurrence-Free Survival
Time from surgery to first documented bladder tumor recurrence confirmed by cystoscopic examination.
Measured: Up to 5 years
Metastasis-Free Survival
Time from surgery to development of distant metastatic disease confirmed by imaging.
Measured: Up to 5 years
Treatment-Related Adverse Events
Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE).
Measured: From treatment initiation to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Tract Urothelial Carcinoma Receiving Kidney-sparing TherapyStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuesong Li, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504939
- Sponsor's protocol ID
- LUXUS3.1
- Status last verified
- Apr 2026
- First submitted
- 8 Mar 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data (IPD) has not yet been determined. Data sharing may be considered after completion of the study and publication of the primary results, subject to institutional policies, ethical approvals, and data protection regulations.
Publications
Sheng X, Zeng G, Zhang C, Zhang Q, Bian J, Niu H, Li J, Shi Y, Yao K, Hu B, Liu Z, Liao H, Yu Z, Jin B, Zhao P, Yang T, Liu X, Qin Y, Xue X, Gou X, Huang J, Gu J, Qi X, Zhang L, Ma G, Liu B, Fang J, Jiang S, He Z, Zhou A, Guo J; RC48-C016 Trial Investigators. Disitamab Vedotin plus Toripalimab in HER2-Expressing Advanced Urothelial Cancer. N Engl J Med. 2025 Dec 11;393(23):2324-2337. doi: 10.1056/NEJMoa2511648. Epub 2025 Oct 19.
PubMed 41124210Coleman JA, Clark PE, Bixler BR, Buckley DI, Chang SS, Chou R, Hoffman-Censits J, Kulkarni GS, Matin SF, Pierorazio PM, Potretzke AM, Psutka SP, Raman JD, Smith AB, Smith L. Diagnosis and Management of Non-Metastatic Upper Tract Urothelial Carcinoma: AUA/SUO Guideline. J Urol. 2023 Jun;209(6):1071-1081. doi: 10.1097/JU.0000000000003480. Epub 2023 Apr 25.
PubMed 37096584Masson-Lecomte A, Birtle A, Pradere B, Capoun O, Comperat E, Dominguez-Escrig JL, Liedberg F, Makaroff L, Mariappan P, Moschini M, Rai BP, van Rhijn BWG, Shariat SF, Smith EJ, Teoh JYC, Soukup V, Wood R, Xylinas EN, Soria F, Seisen T, Gontero P. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Carcinoma: Summary of the 2025 Update. Eur Urol. 2025 Jun;87(6):697-716. doi: 10.1016/j.eururo.2025.02.023. Epub 2025 Mar 20.
PubMed 40118741
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Kidney-sparing Strategy Combining Endoscopic Surgery, Adjuvant Radiotherapy, and HER2-targeted Antibody-Drug Conjugate in High-risk Upper Tract Urothelial Carcinoma: Study Protocol for a Prospective, Multicenter, Non-randomized Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT07504939
- Acronym / sponsor ID
- LUXUS3.1
- Conditions
- Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy, Upper Tract Urothelial Carcinoma
- Keywords
- UTUC, Kidney-Sparing Surgery, Endoscopic Treatment, Disitamab Vedotin, Toripalimab, HER2-Targeted Therapy, Radiotherapy, Multimodal Therapy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
UTUC is a cancer that develops in the lining of the kidney or ureter. The standard treatment is radical nephroureterectomy, which removes the kidney and ureter. Although this surgery can control the cancer, it permanently reduces kidney function.
Endoscopic treatment can serve as a kidney-sparing approach for low-risk UTUC; however, in high-risk patients, the high rate of upper tract local recurrence after endoscopic treatment remains the primary failure pattern. This study aims to evaluate the efficacy and safety of radiotherapy-involved kidney-sparing treatment for UTUC.
The main questions this study aims to answer are: Can this multimodal kidney-sparing strategy reduce local recurrence of UTUC compared with endoscopic treatment alone? Participants in the kidney-sparing group will: Undergo endoscopic surgery to remove the tumor; Receive systemic therapy with disitamab vedotin and toripalimab; Receive targeted radiotherapy after surgery.
Participants will undergo regular follow-up visits, including imaging examinations and endoscopic evaluations, to monitor for recurrence or disease progression.
The results of this study may help determine whether a multimodal kidney-sparing treatment strategy could become a safe and effective option for selected patients with high-risk UTUC.
Detailed description
Upper tract urothelial carcinoma (UTUC) is an uncommon malignancy arising from the urothelial lining of the renal pelvis or ureter. Radical nephroureterectomy (RNU) remains the standard treatment for high-risk disease. However, removal of the entire kidney and ureter leads to permanent loss of renal function and may negatively affect long-term quality of life and eligibility for future systemic therapies. Although kidney-sparing treatment is well established for low-risk UTUC, its role in patients with high-risk disease remains uncertain.
Recent advances in systemic therapy and radiotherapy have created opportunities to explore multimodal treatment strategies aimed at improving oncological control while preserving renal function. HER2 expression appears to be relatively frequent in UTUC, and HER2-targeted antibody-drug conjugates such as disitamab vedotin have demonstrated promising activity in urothelial carcinoma. In addition, immune checkpoint inhibitors have improved outcomes in advanced urothelial malignancies. Radiotherapy has also been reported to improve locoregional tumor control in selected patients. These developments provide the rationale for integrating endoscopic tumor management with systemic therapy and selective radiotherapy as part of a comprehensive kidney-sparing strategy.
This prospective multicenter study is designed to evaluate the feasibility, safety, and preliminary oncological outcomes of a multimodal kidney-sparing treatment pathway in patients with high-risk UTUC.
The findings of this study are expected to provide prospective evidence regarding the feasibility of a multimodal kidney-sparing strategy for selected patients with high-risk UTUC and may inform the design of future confirmatory clinical trials.
Sample size considerations Given the low incidence of UTUC and the fact that kidney-sparing treatment has not yet been established as a standard-of-care for high-risk disease, the sample size calculation was primarily based on a benchmark comparison against previously published outcomes from kidney-sparing treatment cohorts. According to available literature, the reported 1-year DFS rate following endoscopic tumor ablation combined with systemic therapy was approximately 58.82% [Chen Z, Ye J, Tu X, et al. Comprehensive modalities of kidney-sparing treatment in a carefully selected cohort of localized high-risk upper tract urothelial carcinoma: a potential paradigm shift. J Clin Oncol. 2025;43(5_suppl):794-794. doi:10.1200/JCO.2025.43.5_suppl.794]. In this study, we hypothesized that the incorporation of radiotherapy into a comprehensive kidney-sparing strategy would increase the 1-year DFS to 85%. Assuming a two-sided significance level of 0.05 and a statistical power of 80%, and accounting for a 20% dropout rate due to potential loss to follow-up and pathological heterogeneity at enrollment, the required sample size was estimated at 36 patients in the kidney-sparing group.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kidney-Sparing Multimodal Treatment | – | Radiation: SBRTParticipants undergo endoscopic tumor ablation or resection using thulium fiber laser techniques. Participants without confirmed complete tumor resection will receive selective hypofractionated radiotherapy approximately one month after surgery.Postoperative systemic therapy consists of disitamab vedotin administered every three weeks for eight cycles combined with toripalimab administered every three weeks for up to one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically histologically confirmed high-risk upper tract urothelial carcinoma who are evaluated and treated at Peking University First Hospital and participating centers will be screened for eligibility. Participants who meet the inclusion criteria and provide informed consent will be enrolled in the kidney-sparing treatment cohort or the radical nephroureterectomy cohort according to clinical decision-making and treatment preference.
Key inclusion criteria (4 listed)
- Age 18 years or older Voluntary participation with written informed consent Pathology indicating upper tract urothelial carcinoma with HER2 at least 1+ expression Clinical stage cT1-T2N0M0 based on imaging evaluation Classified as high-risk upper tract urothelial carcinoma according to European Association of Urology (EAU) criteria Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Adequate renal function with split renal function of the affected kidney ≥10 mL/min on renal dynamic scintigraphy Expected life expectancy greater than 24 months Ability and willingness to comply with study procedures and follow-up schedule Exclusion Criteria
- Inability to tolerate or refusal of kidney-sparing treatment Evidence of advanced disease (≥T3), lymph node metastasis, or distant metastasis Synchronous bladder urothelial carcinoma or other urological malignancies Previous systemic anticancer therapy, including chemotherapy, targeted therapy, immunotherapy, or antibody-drug conjugates Prior radiotherapy involving the urinary tract or retroperitoneal region Severe uncontrolled comorbidities such as cardiovascular, pulmonary, neurological, psychiatric, or systemic diseases Active severe infections requiring systemic antimicrobial therapy Known immune-related disorders requiring long-term immunosuppressive treatment Pregnancy or breastfeeding Known allergy to investigational drugs used in this study Concurrent participation in another therapeutic clinical trial Indeterminate postoperative pathological diagnosis
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SBRTParticipants without confirmed complete tumor resection will receive selective hypofractionated radiotherapy approximately one month after surgery. | Radiation | Kidney-Sparing Multimodal Treatment |
Primary outcome
One-Year Disease-Free Survival
Time frame: 12 months after surgery
Disease-free survival is defined as the proportion of participants who remain alive without evidence of local recurrence, upper urinary tract recurrence, intravesical recurrence, disease progression, or distant metastasis.
One-Year kidney-sparing rate
Time frame: 12 months after surgery
One-Year kidney-sparing rate is defined as the proportion of participants who do not require conversion to radical nephroureterectomy due to disease progression after initial kidney-sparing treatment.
6 secondary outcomes
Overall Survival
Time frame: Up to 5 years
Progression-Free Survival
Time frame: Up to 5 years
Local Recurrence-Free Survival
Time frame: Up to 5 years
Intravesical Recurrence-Free Survival
Time frame: Up to 5 years
Metastasis-Free Survival
Time frame: Up to 5 years
Treatment-Related Adverse Events
Time frame: From treatment initiation to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 41124210Sheng X, Zeng G, Zhang C, Zhang Q, Bian J, Niu H, Li J, Shi Y, Yao K, Hu B, Liu Z, Liao H, Yu Z, Jin B, Zhao P, Yang T, Liu X, Qin Y, Xue X, Gou X, Huang J, Gu J, Qi X, Zhang L, Ma G, Liu B, Fang J, Jiang S, He Z, Zhou A, Guo J; RC48-C016 Trial Investigators. Disitamab Vedotin plus Toripalimab in HER2-Expressing Advanced Urothelial Cancer. N Engl J Med. 2025 Dec 11;393(23):2324-2337. doi: 10.1056/NEJMoa2511648. Epub 2025 Oct 19.
- Background: PubMed 37096584Coleman JA, Clark PE, Bixler BR, Buckley DI, Chang SS, Chou R, Hoffman-Censits J, Kulkarni GS, Matin SF, Pierorazio PM, Potretzke AM, Psutka SP, Raman JD, Smith AB, Smith L. Diagnosis and Management of Non-Metastatic Upper Tract Urothelial Carcinoma: AUA/SUO Guideline. J Urol. 2023 Jun;209(6):1071-1081. doi: 10.1097/JU.0000000000003480. Epub 2023 Apr 25.
- Background: PubMed 40118741Masson-Lecomte A, Birtle A, Pradere B, Capoun O, Comperat E, Dominguez-Escrig JL, Liedberg F, Makaroff L, Mariappan P, Moschini M, Rai BP, van Rhijn BWG, Shariat SF, Smith EJ, Teoh JYC, Soukup V, Wood R, Xylinas EN, Soria F, Seisen T, Gontero P. European Association of Urology Guidelines on Upper Urinary Tract Urothelial Carcinoma: Summary of the 2025 Update. Eur Urol. 2025 Jun;87(6):697-716. doi: 10.1016/j.eururo.2025.02.023. Epub 2025 Mar 20.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data (IPD) has not yet been determined. Data sharing may be considered after completion of the study and publication of the primary results, subject to institutional policies, ethical approvals, and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Tract Urothelial Carcinoma Receiving Kidney-sparing Therapy and Upper Tract Urothelial Carcinoma, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuesong Li, M.D. (+86-15801399116, pineneedle@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-Year Disease-Free Survival (time frame: 12 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07504939, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.