Neoadjuvant TherapyPhase 2NCT07492225
Neoadjuvant Chemotherapy Before Surgery vs Surgery Alone for UTUC: A Randomized Trial
A Phase 2 study testing Neoadjuvant Gemcitabine + Cisplatin Chemotherapy in people with Neoadjuvant Therapy and Urothelial Carcinoma Ureter, run by Changhai Hospital at 1 site in China.
Trial summary
This clinical trial aims to compare the effectiveness and safety of two treatment options for patients with high-risk upper tract urothelial carcinoma (UTUC). One group will receive neoadjuvant chemotherapy with gemcitabine and cisplatin followed by surgery (radical nephroureterectomy), while the other group will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoadjuvant Therapy, Urothelial Carcinoma Ureter, Upper Urinary Tract Urothelial Carcinoma
- What is being tested?
- Neoadjuvant Gemcitabine + Cisplatin Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 15 Aug 2029
- Phase
- Phase 2
- 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
Who may be able to join
- Histologically confirmed high-risk upper tract urothelial carcinoma (UTUC).
- Clinically non-metastatic UTUC (N≤1, M0) based on imaging (CT/MRI).
- Planned for radical nephroureterectomy (RNU).
- ECOG performance status of 0 or 1.
- Sufficient renal function (GFR ≥45 mL/min) and able to tolerate chemotherapy with cisplatin.
- Age ≥18 years.
- Informed consent signed.
Who cannot join
- Imaging shows ≥N2 disease or metastatic disease (M1).
- History of invasive or lymph node-positive UTUC or invasive disease in the contralateral upper tract in the last 2 years.
- Single kidney or contraindication to cisplatin.
- Currently participating in other interventional clinical trials.
- History of non-urothelial malignancies (except treated skin basal cell carcinoma or cervical carcinoma in situ).
- Pregnant or breastfeeding women.
- Any other medical condition deemed inappropriate by the treating physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Efficacy of Neoadjuvant Chemotherapy Versus Immediate Nephroureterectomy in the Treatment of Localized Upper Tract Urothelial Carcinoma: A Randomized Controlled Trial
This clinical trial aims to compare the effectiveness and safety of two treatment options for patients with high-risk upper tract urothelial carcinoma (UTUC). One group will receive neoadjuvant chemotherapy with gemcitabine and cisplatin followed by surgery (radical nephroureterectomy), while the other group will undergo surgery without chemotherapy. The primary goal is to assess the pathological response to treatment, focusing on how much the tumor shrinks before surgery. The trial will also evaluate the safety of the treatments, overall survival, and recurrence-free survival. This study will help determine whether adding chemotherapy before surgery improves outcomes for patients with high-risk UTUC.
- Conditions
- Neoadjuvant Therapy, Urothelial Carcinoma Ureter, Upper Urinary Tract Urothelial Carcinoma
- Being tested
- Neoadjuvant Gemcitabine + Cisplatin Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Gemcitabine + Cisplatin ChemotherapyDrug
Patients in the experimental group will receive neoadjuvant chemotherapy with a combination of gemcitabine and cisplatin before undergoing surgery. The chemotherapy regimen consists of:
Gemcitabine: 1000 mg/m², administered on Day 1 and Day 8 of each 21-day cycle. Cisplatin: 70 mg/m², administered on Day 2 of each 21-day cycle. This treatment will be repeated for 3 to 4 cycles. The goal of this chemotherapy is to shrink the tumor and improve the chances of a successful surgery. After completing the chemotherapy, patients will undergo radical nephroureterectomy (RNU), a surgery to remove the kidney and ureter affected by cancer, within 6 weeks (+/- 2 weeks) of the last chemotherapy cycle. This approach is designed to evaluate if chemotherapy before surgery can improve pathological response and long-term survival outcomes.
| Study group | Role | What they receive |
|---|---|---|
| NAC+RNU | Experimental | Not described Receives: Drug: Neoadjuvant Gemcitabine + Cisplatin Chemotherapy |
| RNU | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Response Rate
Proportion of patients with ypT1N0 or lower after surgery in the neoadjuvant chemotherapy + partial nephrectomy group compared to the direct partial nephrectomy group.
Measured: 6 weeks after surgery
Secondary outcomes (4)
Chemotherapy Safety and Tolerability
Incidence, severity, and clinical management of treatment-related adverse events (TRAEs) according to CTCAE v5.0.
Measured: During chemotherapy and post-surgery follow-up
Overall Survival (OS)
Time from surgery to death from any cause.
Measured: 24 months after surgery
Cancer-Specific Survival (CSS)
Time from surgery to death due to UTUC.
Measured: 24 months after surgery
Recurrence-Free Survival (RFS)
Time from surgery to first recurrence of UTUC.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start15 Aug 2025
- Primary completion15 Aug 2027 (estimated)
- Study completion15 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant TherapyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492225
- Sponsor's protocol ID
- CH-UTUC NAC vs NNAC
- Status last verified
- Aug 2025
- First submitted
- 19 Mar 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Data Privacy and Ethical Considerations: Due to the sensitive nature of the IPD, which contains private health information, sharing of this data may pose privacy risks and violate regulations such as GDPR or HIPAA. The study's ethical approval also restricts public access to IPD to safeguard patient confidentiality. 2. Data Security: To ensure the protection of patient information and prevent potential data breaches, access to the IPD will be strictly limited to the internal research team. 3. Lack of Data Sharing Agreement: While we support data sharing, a formal agreement with external researchers or public repositories has not been established for this study at present. 4. Group-level Analysis: The primary analyses of this study are based on aggregated group data rather than individual patient-level data. As such, sharing IPD does not significantly impact the reproducibility or verification of the study's results.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Neoadjuvant Chemotherapy Versus Immediate Nephroureterectomy in the Treatment of Localized Upper Tract Urothelial Carcinoma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07492225
- Acronym / sponsor ID
- CH-UTUC NAC vs NNAC
- Conditions
- Neoadjuvant Therapy, Urothelial Carcinoma Ureter, Upper Urinary Tract Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- 15 Aug 2029 (estimated)
- First posted
- 25 Mar 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.
This clinical trial aims to compare the effectiveness and safety of two treatment options for patients with high-risk upper tract urothelial carcinoma (UTUC). One group will receive neoadjuvant chemotherapy with gemcitabine and cisplatin followed by surgery (radical nephroureterectomy), while the other group will undergo surgery without chemotherapy. The primary goal is to assess the pathological response to treatment, focusing on how much the tumor shrinks before surgery. The trial will also evaluate the safety of the treatments, overall survival, and recurrence-free survival. This study will help determine whether adding chemotherapy before surgery improves outcomes for patients with high-risk UTUC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC+RNU | Experimental | Drug: Neoadjuvant Gemcitabine + Cisplatin Chemotherapy |
| RNU | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed high-risk upper tract urothelial carcinoma (UTUC).
- Clinically non-metastatic UTUC (N≤1, M0) based on imaging (CT/MRI).
- Planned for radical nephroureterectomy (RNU).
- ECOG performance status of 0 or 1.
- Sufficient renal function (GFR ≥45 mL/min) and able to tolerate chemotherapy with cisplatin.
Key exclusion criteria (7 listed)
- Imaging shows ≥N2 disease or metastatic disease (M1).
- History of invasive or lymph node-positive UTUC or invasive disease in the contralateral upper tract in the last 2 years.
- Single kidney or contraindication to cisplatin.
- Currently participating in other interventional clinical trials.
- History of non-urothelial malignancies (except treated skin basal cell carcinoma or cervical carcinoma in situ).
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 |
|---|---|---|
| Neoadjuvant Gemcitabine + Cisplatin ChemotherapyPatients in the experimental group will receive neoadjuvant chemotherapy with a combination of gemcitabine and cisplatin before undergoing surgery. The chemotherapy regimen consists of: Gemcitabine: 1000 mg/m², administered on Day 1 and Day 8 of each 21-day cycle. Cisplatin: 70 mg/m², administered on Day 2 of each 21-day cycle. This treatment will be repeated for 3 to 4 cycles. The goal of this chemotherapy is to shrink the tumor and improve the chances of a successful surgery. After completing the chemotherapy, patients will undergo radical nephroureterectomy (RNU), a surgery to remove the kidney and ureter affected by cancer, within 6 weeks (+/- 2 weeks) of the last chemotherapy cycle. This approach is designed to evaluate if chemotherapy before surgery can improve pathological response and long-term survival outcomes. | Drug | NAC+RNU |
Primary outcome
Pathological Response Rate
Time frame: 6 weeks after surgery
Proportion of patients with ypT1N0 or lower after surgery in the neoadjuvant chemotherapy + partial nephrectomy group compared to the direct partial nephrectomy group.
4 secondary outcomes
Chemotherapy Safety and Tolerability
Time frame: During chemotherapy and post-surgery follow-up
Overall Survival (OS)
Time frame: 24 months after surgery
Cancer-Specific Survival (CSS)
Time frame: 24 months after surgery
Recurrence-Free Survival (RFS)
Time frame: 24 months after surgery
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 25 Mar 2026.
- Individual participant dataSharing planned: No. 1. Data Privacy and Ethical Considerations: Due to the sensitive nature of the IPD, which contains private health information, sharing of this data may pose privacy risks and violate regulations such as GDPR or HIPAA. The study's ethical approval also restricts public access to IPD to safeguard patient confidentiality. 2. Data Security: To ensure the protection of patient information and prevent potential data breaches, access to the IPD will be strictly limited to the internal research team. 3. Lack of Data Sharing Agreement: While we support data sharing, a formal agreement with external researchers or public repositories has not been established for this study at present. 4. Group-level Analysis: The primary analyses of this study are based on aggregated group data rather than individual patient-level data. As such, sharing IPD does not significantly impact the reproducibility or verification of the study's results.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Neoadjuvant Gemcitabine + Cisplatin Chemotherapy in people with Neoadjuvant Therapy and Urothelial Carcinoma Ureter, run by Changhai 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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Response Rate (time frame: 6 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.