Muscle-Invasive Bladder Cancer (MIBC)Phase 2NCT07647289
EV + Toripalimab vs GC as Neoadjuvant Therapy in Locally Advanced/High-Risk MIBC
A Phase 2 study testing enfortumab vedotin (EV), Toripalimab and Gemcitabine (Chemotherapy) in people with Muscle-Invasive Bladder Cancer (MIBC), run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this Phase II, open-label, multicenter, randomized controlled study is to evaluate the efficacy and safety of Enfortumab Vedotin in combination with Toripalimab compared to Gemcitabine plus Cisplatin. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Muscle-Invasive Bladder Cancer (MIBC)
- What is being tested?
- enfortumab vedotin (EV), Toripalimab and Gemcitabine (Chemotherapy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteChina
- Study dates
- 15 Apr 2025to Dec 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate in the study and sign the informed consent form (ICF).
- Age ≥ 18 and ≤ 80 years at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, with variant histology components comprising < 50%.
- Radiographically confirmed non-metastatic urothelial carcinoma (M0). Clinical stage must be locally advanced or possess high-risk features, including at least one of the following: clinical stage cT3-T4aNxM0, or definitive high-risk cT2 (e.g., accompanied by tumor-related hydronephrosis, lymphovascular invasion).
- Participants must be evaluated as fit for and scheduled to undergo radical surgery, and clinically fit to tolerate cisplatin-based chemotherapy.
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- Able to provide tumor tissue samples (at least 5 unstained slides, or paraffin scrolls/blocks).
- Expected life expectancy of at least 12 weeks.
- Adequate organ function, defined by the following laboratory values (obtained without blood transfusion within 14 days or growth factor support within 7 days prior to testing): Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count (PLT) ≥ 100 × 10^9/L; Hemoglobin (Hb) ≥ 90 g/L; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × Upper Limit of Normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; International Normalized Ratio (INR) ≤ 1.5 × ULN; Creatinine clearance ≥ 60 mL/min (calculated using the Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) ≥ 50%; QTcF interval ≤ 480 ms.
- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment and must be willing to use highly effective contraception during the study and for 180 days after the last dose.
- Male participants with female partners of childbearing potential must be surgically sterile or willing to use highly effective contraception during the study and for 180 days after the last dose.
- Able to understand and comply with study visits, treatment plans, laboratory tests, and other study procedures.
Who cannot join
- Prior systemic anti-tumor therapy for urothelial carcinoma, including radiotherapy, chemotherapy, targeted therapy, or biological therapy (except for intravesical instillation therapy).
- Prior treatment with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs).
- Active malignancies other than urothelial carcinoma within 3 years prior to the first dose, except for curatively treated malignancies (e.g., basal or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast).
- Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose; or received high-dose steroids (>10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose. (Physiological replacement therapies are permitted).
- Severe thromboembolic events or severe cardiovascular/cerebrovascular diseases within 1 year prior to the first dose, including but not limited to myocardial infarction, unstable angina, pulmonary embolism, cerebral hemorrhage, cerebral infarction, and deep vein thrombosis.
- Major surgical procedure within 28 days prior to the first dose; or cystoscopy/ureteroscopy biopsy or intravesical therapy within 7 days prior to the first dose.
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- Peripheral neuropathy ≥ Grade 2.
- Severe dry eye syndrome, active keratitis, corneal ulcers, or conditions assessed by the investigator as increasing the risk of corneal disease and unsuitable for participation.
- Active infections, including: Positive HBsAg with HBV-DNA copy number ≥ 500 IU/mL; Positive HCV antibody with positive HCV-RNA; Positive HIV antibody; Active tuberculosis infection; Other active infections requiring systemic therapy within 7 days prior to the first dose.
- Other severe or uncontrolled diseases, including but not limited to: Severe respiratory diseases (e.g., moderate-to-severe interstitial or obstructive pulmonary disease, severe asthma); New York Heart Association (NYHA) Class III or IV heart failure; HbA1c ≥ 8% (except for participants whose fasting blood glucose is stably controlled at ≤ 10 mmol/L with medication); Poorly controlled hypertension (systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg); Large pleural effusion or ascites requiring symptomatic treatment within 14 days prior to the first dose.
- Receipt of live vaccines within 28 days prior to the first dose or plans to receive live vaccines during the study.
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Use of strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose.
- Known severe hypersensitivity or intolerance to the study drugs or any of their excipients.
- Substance abuse or psychiatric disorders that may interfere with study compliance.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
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
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Clinical Trial Office, +86 10 8226 5573, bysy@bjmu.edu.cn
About this study
Official title: A Phase II, Two-arm, Open-label, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Enfortumab Vedotin Combined With Toripalimab Versus Gemcitabine Combined With Cisplatin in the Neoadjuvant Treatment of Patients With Locally Advanced/High-risk Muscle-invasive Bladder Cancer
The purpose of this Phase II, open-label, multicenter, randomized controlled study is to evaluate the efficacy and safety of Enfortumab Vedotin in combination with Toripalimab compared to Gemcitabine plus Cisplatin. This regimen is evaluated as a neoadjuvant treatment for patients with locally advanced or high-risk muscle-invasive bladder cancer. Participants will be randomly assigned in a 1:1 ratio to one of two cohorts. Cohort A will receive Enfortumab Vedotin and Toripalimab for 3 treatment cycles. Cohort B will receive Gemcitabine and Cisplatin for 3 treatment cycles. Following the neoadjuvant treatment phase, patients will undergo radical cystectomy and pelvic lymph node dissection. The primary endpoint of the study is the 1-year Event-Free Survival (EFS) rate. Secondary endpoints include pathological downstaging rate (pDR), pathological complete response (pCR), Disease-Free Survival (DFS), Overall Survival (OS), and the assessment of adverse events. Additionally, the study will evaluate the relationship between treatment efficacy and the expression of PD-L1 and Nectin-4 in tumor tissues.
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC)
- Being tested
- enfortumab vedotin (EV), Toripalimab, Gemcitabine (Chemotherapy), Cisplatin
- Keywords
- MIBC, Neoadjuvant Therapy, Enfortumab Vedotin, Toripalimab, Antibody-Drug Conjugates, Nectin-4, Urothelial Carcinoma
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enfortumab vedotin (EV)Drug
Enfortumab Vedotin is administered intravenously at a dose of 1.25 mg/kg on Day 1 and Day 8 of each 21-day cycle for a total of 3 cycles
ToripalimabDrug
Toripalimab is administered intravenously at a dose of 240 mg on Day 1 of each 21-day cycle for a total of 3 cycles.
Gemcitabine (Chemotherapy)Drug
Gemcitabine is administered intravenously at a dose of 1000 mg/m² on Day 1 and Day 8 of each 21-day cycle for a total of 3 cycles.
CisplatinDrug
Cisplatin is administered intravenously at a dose of 70 mg/m² on Day 1 of each 21-day cycle for a total of 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Enfortumab Vedotin + Toripalimab | Experimental | Participants in this arm will receive neoadjuvant therapy consisting of Enfortumab Vedotin and Toripalimab. Enfortumab Vedotin (1.25 mg/kg) will be administered intravenously on Days 1 and 8 of each 21-day cycle. Toripalimab (240 mg) will be administered intravenously on Day 1 of each 21-day cycle. The treatment will be administered for a total of 3 cycles, followed by radical cystectomy and pelvic lymph node dissection. Receives: Drug: enfortumab vedotin (EV); Drug: Toripalimab |
| Active Comparator: Gemcitabine + Cisplatin | Active comparator | Participants in this arm will receive standard neoadjuvant chemotherapy consisting of Gemcitabine and Cisplatin. Gemcitabine (1000 mg/m^2) will be administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin (70 mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle. The treatment will be administered for a total of 3 cycles, followed by radical cystectomy and pelvic lymph node dissection. Receives: Drug: Gemcitabine (Chemotherapy); Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Year Event-Free Survival (EFS) Rate
The percentage of participants who remain free of an event at 1 year. An event is defined as the first occurrence of any of the following: 1) radiographically confirmed disease progression during neoadjuvant therapy (per RECIST v1.1); 2) unresectable tumor or extensive pelvic metastasis identified during surgical exploration; 3) any type of local recurrence or distant metastasis (confirmed radiologically or pathologically) after radical surgery; 4) death from any cause.
Measured: Up to 1 year post-surgery
Secondary outcomes (6)
Pathological Complete Response (pCR) Rate
The percentage of participants achieving a pathological complete response, defined as the absence of residual tumor in the bladder and lymph nodes (ypT0N0) upon postoperative pathological evaluation.
Measured: At the time of radical surgery (Expected to be within 4-6 weeks after the last cycle of neoadjuvant therapy)
Pathological Downstaging Rate (pDR)
The percentage of participants achieving pathological downstaging, defined as pathological stage ≤ ypT1N0 upon postoperative pathological evaluation.
Measured: At the time of radical surgery (Expected to be within 4-6 weeks after the last cycle of neoadjuvant therapy)
Disease-Free Survival (DFS)
The time from the date of radical surgery to the first documented local recurrence or distant metastasis (identified radiologically or pathologically), or death from any cause, whichever occurs first.
Measured: From the date of radical surgery up to study completion (Assessed every 12 weeks for the first 48 weeks, then every 24 weeks, estimated up to 3 years)
Overall Survival (OS)
The time from the date of randomization to death from any cause.
Measured: From the date of randomization up to study completion (Assessed every 12 weeks, estimated up to 3 years)
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety will be evaluated by the incidence, severity, and causality of AEs and SAEs. The severity of adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
Measured: From the first dose of study drug up to 28 days after the last dose (or before starting new anti-tumor therapy, whichever is earlier)
Biomarker Expression: Nectin-4 and PD-L1
To evaluate the expression levels of Nectin-4 and PD-L1 in tumor tissue samples (obtained at baseline and post-surgery) and to analyze the relationship between these biomarker expressions and clinical efficacy.
Measured: Baseline (Screening) and at the time of radical surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start15 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle-Invasive Bladder Cancer (MIBC)Studies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647289
- Sponsor's protocol ID
- LM2025412
- Other IDs
- M20250227, IRB00006761
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing has not been determined at this time. Decisions regarding IPD sharing will be made in accordance with applicable regulations, institutional policies, and sponsor agreements
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Two-arm, Open-label, Multicenter, Randomized Controlled Clinical Study Evaluating the Safety and Efficacy of Enfortumab Vedotin Combined With Toripalimab Versus Gemcitabine Combined With Cisplatin in the Neoadjuvant Treatment of Patients With Locally Advanced/High-risk Muscle-invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07647289
- Acronym / sponsor ID
- LM2025412
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC)
- Keywords
- MIBC, Neoadjuvant Therapy, Enfortumab Vedotin, Toripalimab, Antibody-Drug Conjugates, Nectin-4, Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Provincial People's Hospital, Peking University Cancer Hospital & Institute
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jun 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.
The purpose of this Phase II, open-label, multicenter, randomized controlled study is to evaluate the efficacy and safety of Enfortumab Vedotin in combination with Toripalimab compared to Gemcitabine plus Cisplatin. This regimen is evaluated as a neoadjuvant treatment for patients with locally advanced or high-risk muscle-invasive bladder cancer. Participants will be randomly assigned in a 1:1 ratio to one of two cohorts. Cohort A will receive Enfortumab Vedotin and Toripalimab for 3 treatment cycles. Cohort B will receive Gemcitabine and Cisplatin for 3 treatment cycles. Following the neoadjuvant treatment phase, patients will undergo radical cystectomy and pelvic lymph node dissection. The primary endpoint of the study is the 1-year Event-Free Survival (EFS) rate. Secondary endpoints include pathological downstaging rate (pDR), pathological complete response (pCR), Disease-Free Survival (DFS), Overall Survival (OS), and the assessment of adverse events. Additionally, the study will evaluate the relationship between treatment efficacy and the expression of PD-L1 and Nectin-4 in tumor tissues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Enfortumab Vedotin + Toripalimab | Experimental | Drug: enfortumab vedotin (EV), Drug: ToripalimabParticipants in this arm will receive neoadjuvant therapy consisting of Enfortumab Vedotin and Toripalimab. Enfortumab Vedotin (1.25 mg/kg) will be administered intravenously on Days 1 and 8 of each 21-day cycle. Toripalimab (240 mg) will be administered intravenously on Day 1 of each 21-day cycle. The treatment will be administered for a total of 3 cycles, followed by radical cystectomy and pelvic lymph node dissection. |
| Active Comparator: Gemcitabine + Cisplatin | Active comparator | Drug: Gemcitabine (Chemotherapy), Drug: CisplatinParticipants in this arm will receive standard neoadjuvant chemotherapy consisting of Gemcitabine and Cisplatin. Gemcitabine (1000 mg/m^2) will be administered intravenously on Days 1 and 8 of each 21-day cycle. Cisplatin (70 mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle. The treatment will be administered for a total of 3 cycles, followed by radical cystectomy and pelvic lymph node dissection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily agree to participate in the study and sign the informed consent form (ICF).
- Age ≥ 18 and ≤ 80 years at the time of signing the ICF.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, with variant histology components comprising < 50%.
- Radiographically confirmed non-metastatic urothelial carcinoma (M0). Clinical stage must be locally advanced or possess high-risk features, including at least one of the following: clinical stage cT3-T4aNxM0, or definitive high-risk cT2 (e.g., accompanied by tumor-related hydronephrosis, lymphovascular invasion).
Key exclusion criteria (16 listed)
- Prior systemic anti-tumor therapy for urothelial carcinoma, including radiotherapy, chemotherapy, targeted therapy, or biological therapy (except for intravesical instillation therapy).
- Prior treatment with PD-1/PD-L1 inhibitors or antibody-drug conjugates (ADCs).
- Active malignancies other than urothelial carcinoma within 3 years prior to the first dose, except for curatively treated malignancies (e.g., basal or squamous cell skin cancer, localized low-risk prostate cancer, papillary thyroid cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast).
- Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose; or received high-dose steroids (>10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose. (Physiological replacement therapies are permitted).
- Severe thromboembolic events or severe cardiovascular/cerebrovascular diseases within 1 year prior to the first dose, including but not limited to myocardial infarction, unstable angina, pulmonary embolism, cerebral hemorrhage, cerebral infarction, and deep vein thrombosis.
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 |
|---|---|---|
| enfortumab vedotin (EV)Enfortumab Vedotin is administered intravenously at a dose of 1.25 mg/kg on Day 1 and Day 8 of each 21-day cycle for a total of 3 cycles | Drug | Experimental: Enfortumab Vedotin + Toripalimab |
| ToripalimabToripalimab is administered intravenously at a dose of 240 mg on Day 1 of each 21-day cycle for a total of 3 cycles. | Drug | Experimental: Enfortumab Vedotin + Toripalimab |
| Gemcitabine (Chemotherapy)Gemcitabine is administered intravenously at a dose of 1000 mg/m² on Day 1 and Day 8 of each 21-day cycle for a total of 3 cycles. | Drug | Active Comparator: Gemcitabine + Cisplatin |
| CisplatinCisplatin is administered intravenously at a dose of 70 mg/m² on Day 1 of each 21-day cycle for a total of 3 cycles. | Drug | Active Comparator: Gemcitabine + Cisplatin |
Primary outcome
1-Year Event-Free Survival (EFS) Rate
Time frame: Up to 1 year post-surgery
The percentage of participants who remain free of an event at 1 year. An event is defined as the first occurrence of any of the following: 1) radiographically confirmed disease progression during neoadjuvant therapy (per RECIST v1.1); 2) unresectable tumor or extensive pelvic metastasis identified during surgical exploration; 3) any type of local recurrence or distant metastasis (confirmed radiologically or pathologically) after radical surgery; 4) death from any cause.
6 secondary outcomes
Pathological Complete Response (pCR) Rate
Time frame: At the time of radical surgery (Expected to be within 4-6 weeks after the last cycle of neoadjuvant therapy)
Pathological Downstaging Rate (pDR)
Time frame: At the time of radical surgery (Expected to be within 4-6 weeks after the last cycle of neoadjuvant therapy)
Disease-Free Survival (DFS)
Time frame: From the date of radical surgery up to study completion (Assessed every 12 weeks for the first 48 weeks, then every 24 weeks, estimated up to 3 years)
Overall Survival (OS)
Time frame: From the date of randomization up to study completion (Assessed every 12 weeks, estimated up to 3 years)
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the first dose of study drug up to 28 days after the last dose (or before starting new anti-tumor therapy, whichever is earlier)
Biomarker Expression: Nectin-4 and PD-L1
Time frame: Baseline (Screening) and at the time of radical 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 15 Jun 2026.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing has not been determined at this time. Decisions regarding IPD sharing will be made in accordance with applicable regulations, institutional policies, and sponsor agreements
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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?
A Phase 2 study testing enfortumab vedotin (EV), Toripalimab and Gemcitabine (Chemotherapy) in people with Muscle-Invasive Bladder Cancer (MIBC), run by Peking University Third 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 12 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 15 Jun 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Year Event-Free Survival (EFS) Rate (time frame: Up to 1 year post-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 15 Jun 2026.