Muscle Invasive Bladder Urothelial CarcinomaPhase 2NCT06257017
Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma
A Phase 2 study testing gemcitabine and Cisplatin in people with Muscle Invasive Bladder Urothelial Carcinoma and Muscle-Invasive Bladder Carcinoma, run by Yung NA at 1 site in Hong Kong.
Trial summary
Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Muscle Invasive Bladder Urothelial Carcinoma, Muscle-Invasive Bladder Carcinoma
- What is being tested?
- gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteHong Kong
- Study dates
- 2 Feb 2024to 22 Aug 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18-70 years old;
- a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status;
- receiving radical cystectomy (with lymph node dissection) or nephroureterectomy;
- histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma;
- Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0;
- absence of microscopic (i.e., positive margin) or gross residual of the tumor (R0 resection) and absence of metastasis, confirmed by a negative CT or MRI scan of pelvis, abdomen and chest within 4 weeks prior to enrolment;
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- adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:
- ANC≥1500 cells/μL (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1)
- WBC counts > 2500 cells/μL
- Lymphocyte count ≥ 300 cells/μL
- Platelet count ≥ 100,000 cells/μL (without transfusion within 2 weeks prior to Cycle 1, Day 1)
- Hemoglobin ≥ 9.0 g/dL
- AST, ALT, and alkaline phosphatase ≤ 2.5 × the upper limit of normal (ULN),
- PTT ≤ 1.5 × ULN
- PT ≤ 1.5 × ULN or INR < 1.7
- Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
- able to understand and provide written informed consent, and agree to receive the treatment arrangement and study procedures stated in the informed consent
Who cannot join
- receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment;
- participation in another clinical trial with therapeutic intent within 28 days prior to enrolment;
- suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment;
- conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) <50 mL/min, hearing impairment, and inadequate marrow function;
- anaphylactic or hypersensitivity reactions or other contraindication to cisplatin and gemcitabine;
- active or uncontrolled infections, including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or tuberculosis;
- pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial
Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. However, currently in Hong Kong, neoadjuvant (preoperational) chemotherapy and adjuvant (postoperative) chemotherapy are not commonly or regularly provided due to the concern of the potential harm from both physicians and patients. Recently, genetic signature from circulating tumor DNA (ctDNA) is emerging as a pivotal biomarker for detecting caner in early stage and molecular residual disease (MRD). With strengths of non-invasive and superior sensitivity, ctDNA is hopefully to serve as a cancer-agnostic surrogate analyte for risk stratification of tumor recurrence, thereby guiding individually tailored treatment. Therefore, this study is proposed to exploratively assess the benefit of ctDNA-guided approach for postoperative adjuvant therapy.
- Being tested
- gemcitabine, Cisplatin
- Keywords
- circulating tumor DNA, ctDNA, molecular residual disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
1,000 mg/m2 intravenous gemcitabine on day 1 and day 8
CisplatinDrug
70 mg/m2 intravenous cisplatin (split into 2 doses on day 1 and day 8)
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine plus cisplatin chemotherapy arm (GC arm) | Experimental | Patients in this group will receive adjuvant chemotherapy of gemcitabine and cisplatin, prior to radiological progression Receives: Drug: gemcitabine; Drug: Cisplatin |
| Standard management arm (SM arm) | Other | Patients in this group will receive chemotherapy of gemcitabine and cisplatin only after radiological progression is observed Receives: Drug: gemcitabine; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the radiational disease-free survival (rDFS)
Measured: 1 year
Secondary outcomes (3)
Progression Free Survival (PFS)
time to recurrence
Measured: 1 year
Overall Survival (OS)
Measured: 5 year
ctDNA clearance rate in ctDNA(+) patients
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start2 Feb 2024
- Primary completion30 Sep 2025
- Study completion22 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Invasive Bladder Urothelial CarcinomaStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yung NA
- Sponsor type
- University, hospital or other
- Collaborators
- Pamela Youde Nethersole Eastern Hospital, Queen Mary Hospital, Hong Kong
- Responsible party
- Sponsor-investigator, Yung NA, The University of Hong Kong
- Investigators
- Yung Na, PHD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257017
- Sponsor's protocol ID
- HKURO202401
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhan Y, Ruan X, Wu Y, Chun TTS, Yao C, Shi R, Liu J, Ali S, Ma R, Huang D, Gao Y, Xu Y, Chen L, Du Q, Ng AT, Li CWB, Xu D, Na R. Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 26;14:e72597. doi: 10.2196/72597.
PubMed 40857715
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06257017
- Acronym / sponsor ID
- HKURO202401
- Keywords
- circulating tumor DNA, ctDNA, molecular residual disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Yung NAUniversity, hospital or other
- Collaborators
- Pamela Youde Nethersole Eastern Hospital, Queen Mary Hospital, Hong Kong
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 22 Aug 2026 (actual)
- First posted
- 13 Feb 2024 (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.
Urothelial carcinomas are one of the most commonly diagnosed cancers worldwide. Postoperative patients carry a poor prognosis with an estimated five-year disease-specific survival rate of 50%. To improve overall survival and reduce the recurrent risk, chemotherapy is recommended as a standard of care. However, currently in Hong Kong, neoadjuvant (preoperational) chemotherapy and adjuvant (postoperative) chemotherapy are not commonly or regularly provided due to the concern of the potential harm from both physicians and patients. Recently, genetic signature from circulating tumor DNA (ctDNA) is emerging as a pivotal biomarker for detecting caner in early stage and molecular residual disease (MRD). With strengths of non-invasive and superior sensitivity, ctDNA is hopefully to serve as a cancer-agnostic surrogate analyte for risk stratification of tumor recurrence, thereby guiding individually tailored treatment. Therefore, this study is proposed to exploratively assess the benefit of ctDNA-guided approach for postoperative adjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine plus cisplatin chemotherapy arm (GC arm) | Experimental | Drug: gemcitabine, Drug: CisplatinPatients in this group will receive adjuvant chemotherapy of gemcitabine and cisplatin, prior to radiological progression |
| Standard management arm (SM arm) | Other | Drug: gemcitabine, Drug: CisplatinPatients in this group will receive chemotherapy of gemcitabine and cisplatin only after radiological progression is observed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- aged 18-70 years old;
- a score of ≤1 for the Eastern Cooperative Oncology Group (ECOG) Performance Status;
- receiving radical cystectomy (with lymph node dissection) or nephroureterectomy;
- histologically confirmed (surgical specimen) muscle invasive urothelial carcinoma, and the major histological type should be transitional cell carcinoma;
- Classification of tumour, node and metastasis (TNM): pT2-4a N0-2M0;
Key exclusion criteria (7 listed)
- receiving any approved anti-cancer treatment within 3 weeks prior to study enrolment;
- participation in another clinical trial with therapeutic intent within 28 days prior to enrolment;
- suffering from malignancies other than urothelial carcinoma within 5 years prior to study enrolment;
- conditions that contraindicate chemotherapy, such as renal impairment with creatinine clearance rate (CCr) <50 mL/min, hearing impairment, and inadequate marrow function;
- anaphylactic or hypersensitivity reactions or other contraindication to cisplatin and gemcitabine;
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 |
|---|---|---|
| gemcitabine1,000 mg/m2 intravenous gemcitabine on day 1 and day 8 | Drug | Gemcitabine plus cisplatin chemotherapy arm (GC arm), Standard management arm (SM arm) |
| Cisplatin70 mg/m2 intravenous cisplatin (split into 2 doses on day 1 and day 8) | Drug | Gemcitabine plus cisplatin chemotherapy arm (GC arm), Standard management arm (SM arm) |
Primary outcome
the radiational disease-free survival (rDFS)
Time frame: 1 year
3 secondary outcomes
Progression Free Survival (PFS)
Time frame: 1 year
Overall Survival (OS)
Time frame: 5 year
ctDNA clearance rate in ctDNA(+) patients
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Derived from this study: PubMed 40857715Zhan Y, Ruan X, Wu Y, Chun TTS, Yao C, Shi R, Liu J, Ali S, Ma R, Huang D, Gao Y, Xu Y, Chen L, Du Q, Ng AT, Li CWB, Xu D, Na R. Surveillance of the Genetic Signature in Circulating Tumor DNA for Guiding Adjuvant Chemotherapy in Urothelial Carcinoma: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Aug 26;14:e72597. doi: 10.2196/72597.
- Individual participant dataSharing planned: No
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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.
Yung Na, PHD principal investigator
The University of Hong Kong
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 gemcitabine and Cisplatin in people with Muscle Invasive Bladder Urothelial Carcinoma and Muscle-Invasive Bladder Carcinoma, run by Yung NA at 1 site in Hong Kong.
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 17 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: finished, as of the sponsor's last update on 28 Oct 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the radiational disease-free survival (rDFS) (time frame: 1 year). 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 NCT06257017, which also lists 1 linked publication.
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 28 Oct 2026.