Muscle-Invasive Bladder Cancer (MIBC)Phase 2RG-BP-MIBCNCT07865611
Response-Guided Bladder Preservation With Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy in HER2-Expressing Muscle-Invasive Bladder Cancer
A Phase 2 study testing Trastuzumab Rezetecan, Adebrelimab and Concurrent Bladder Radiotherapy in people with Muscle-Invasive Bladder Cancer (MIBC), run by Tongji Hospital at 1 site in China.
Trial summary
This prospective, multicenter, open-label phase II study will evaluate a response-guided bladder-preservation strategy in patients with HER2-expressing muscle-invasive bladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle-Invasive Bladder Cancer (MIBC)
- What is being tested?
- Trastuzumab Rezetecan, Adebrelimab and Concurrent Bladder Radiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, male or female; able to provide written informed consent; willing and able to comply with all protocol-required examinations and follow-up.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Minor squamous, glandular, or other mixed differentiation is permitted. Patients with pure non-urothelial carcinoma may be enrolled at the investigator's discretion.
- Clinical stage cT2-T4a, N0, M0, based on pelvic/abdominal imaging with or without chest imaging.
- HER2 expression of IHC 1+, 2+, or 3+ in tumor tissue, as determined by a central or designated laboratory.
- Suitable for maximal transurethral resection of the bladder tumor (TURBT) and considered by a multidisciplinary team to be eligible for radical cystectomy if required.
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- Adequate organ function: absolute neutrophil count ≥1.5 × 10^9/L; platelet count ≥100 × 10^9/L; hemoglobin ≥90 g/L; ALT and AST ≤2.5 × upper limit of normal (ULN); total bilirubin ≤1.5 × ULN; eGFR ≥50 mL/min/1.73 m² or CrCl ≥50 mL/min; INR ≤1.5 × ULN if not receiving anticoagulant therapy; left ventricular ejection fraction ≥50% or the institutional lower limit of normal; and no uncontrolled clinically significant cardiovascular disease.
- No active interstitial lung disease or pneumonitis on baseline pulmonary assessment, including chest CT.
- Participants of childbearing potential must agree to use effective contraception during the study and for the protocol-specified period after the last dose. A negative pregnancy test is required when applicable.
Who cannot join
- 1. Distant metastasis (M1), clearly uncontrollable extra-regional metastatic disease, or an upper urinary tract tumor requiring priority treatment.
- 2. Previous systemic anticancer treatment for the current bladder cancer, including chemotherapy, immunotherapy, anti-HER2 targeted therapy, or antibody-drug conjugates, or previous pelvic radiotherapy that could affect the delivery or safety of study radiotherapy.
- 3. Unable to complete protocol-required local treatment, including inability to undergo maximal TURBT or the presence of a contraindication to radiotherapy, such as previous high-dose irradiation to the same region or active inflammatory bowel disease.
- 4. Active autoimmune disease or a history requiring long-term systemic immunosuppressive treatment, including prednisone ≥10 mg/day or equivalent within 14 days before treatment. Physiologic replacement doses are permitted.
- 5. Active pneumonitis or interstitial lung disease, or a history of severe drug-related pneumonitis.
- 6. Uncontrolled infection, including active tuberculosis, or HBV, HCV, or HIV infection considered unsuitable for enrollment by the investigator. Patients with markedly elevated HBV DNA who are not receiving appropriate antiviral treatment are excluded.
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- 7. Another malignancy within the previous 5 years, except adequately treated low-risk malignancies such as basal cell carcinoma of the skin or carcinoma in situ of the cervix.
- 8. Known active central nervous system metastases. Previously treated brain metastases may be permitted if radiographically stable for ≥4 weeks and systemic corticosteroids have been discontinued for >2 weeks.
- 9. Uncontrolled hypertension despite antihypertensive treatment, defined as systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg.
- 10. Abnormal coagulation, including INR >2.0 or prothrombin time >16 seconds, a bleeding tendency, or current thrombolytic or anticoagulant therapy. Prophylactic low-dose aspirin or low-molecular-weight heparin is permitted.
- 11. Any bleeding event of CTCAE version 5.0 grade 2 or higher within 4 weeks before the first dose.
- 12. Imaging evidence of tumor invasion of major blood vessels or, in the investigator's judgment, a very high risk of invasion of major blood vessels resulting in fatal hemorrhage during treatment.
- 13. An arterial or venous thrombotic event within 6 months before the first dose, including cerebrovascular accident, transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep-vein thrombosis, or pulmonary embolism.
- 14. Radiation enteritis caused by pelvic radiotherapy received within 12 months before study treatment.
- 15. Active infection, unexplained fever ≥38.5°C within 7 days before treatment, or baseline white blood cell count >15 × 10^9/L.
- 16. Known interstitial lung disease, evidence or history of noninfectious pneumonitis requiring corticosteroid treatment, or any condition that may interfere with the detection or management of suspected drug-related pulmonary toxicity.
- 17. Clinically significant uncontrolled comorbidity, including New York Heart Association class III-IV heart failure, recent myocardial infarction or unstable angina, severe arrhythmia, or poorly controlled hypertension.
- 18. History of severe hypersensitivity to adebrelimab, trastuzumab rezetecan, or any component or excipient of either study drug.
- 19. Pregnant or breastfeeding women. 20. Any other condition that, in the investigator's judgment, may affect participant safety, efficacy assessment, or protocol compliance, such as severe psychiatric illness or inability to attend regular follow-up.
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
Tongji Hospital
Wuhan, Hubei, 430030
Wen Song, +86 18971040867, sgwangtjm@163.com
Shaogang Wang
About this study
Official title: A Prospective, Multicenter, Open-Label Phase II Study of Response-Guided Bladder Preservation With Trastuzumab Rezetecan Plus Adebrelimab and Concurrent Bladder Radiotherapy in Patients With HER2-Expressing Muscle-Invasive Bladder Cancer
This prospective, multicenter, open-label phase II study will evaluate a response-guided bladder-preservation strategy in patients with HER2-expressing muscle-invasive bladder cancer. Participants will receive maximal transurethral resection of the bladder tumor, trastuzumab rezetecan plus adebrelimab, and concurrent bladder radiotherapy. Treatment response will be assessed by cystoscopic biopsy or diagnostic transurethral resection at 8 weeks (±2 weeks) after radiotherapy. Participants with a pathological stage of T1 or lower may continue bladder-preserving management, whereas radical cystectomy will be recommended for participants with disease above T1. The primary outcome is the major pathological response rate.
Read the detailed description
This is a prospective, multicenter, open-label, single-arm phase II study designed to evaluate the efficacy and safety of a response-guided bladder-preserving strategy using trastuzumab rezetecan plus adebrelimab in combination with bladder radiotherapy in patients with HER2-expressing muscle-invasive bladder cancer (MIBC).
Approximately 70 participants with clinically staged cT2-T4a, N0, M0 MIBC will be enrolled. Eligible participants will undergo maximal transurethral resection of the bladder tumor (TURBT), followed by trastuzumab rezetecan at 4.8 mg/kg intravenously every 3 weeks for 4 cycles and adebrelimab at 1200 mg intravenously every 3 weeks for 4 cycles.
Bladder radiotherapy will be initiated concurrently with systemic therapy and delivered to a total dose of 60-64 Gy in 30-32 fractions, at 2.0 Gy per fraction, once daily, 5 fractions per week, over approximately 6 weeks.
At 8 weeks (±2 weeks) after completion of radiotherapy, participants will undergo cystoscopic biopsy or diagnostic TURBT to assess pathological response. Participants with a pathological stage of T1 or lower (ypT0, ypTa, ypTis, or ypT1) may continue bladder-preserving management with close surveillance. Radical cystectomy will be recommended for participants with residual disease above pathological stage T1.
The primary outcome is the major pathological response rate, defined as the proportion of participants with a pathological stage of T1 or lower at post-radiotherapy assessment. Secondary outcomes include event-free survival, overall survival, bladder preservation rate, 1-year and 2-year bladder event-free survival, and safety and tolerability.
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC)
- Being tested
- Trastuzumab Rezetecan, Adebrelimab, Concurrent Bladder Radiotherapy, Transurethral Resection of Bladder Tumor
- Keywords
- HER2-Expressing Bladder Cancer, Bladder Preservation, Trastuzumab Rezetecan, Adebrelimab, Concurrent Radiotherapy, Response-Guided Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab RezetecanDrug
Trastuzumab rezetecan will be administered intravenously at a dose of 4.8 mg/kg every 3 weeks for 4 cycles.
AdebrelimabDrug
Adebrelimab will be administered intravenously at a dose of 1200 mg every 3 weeks for 4 cycles.
Concurrent Bladder RadiotherapyRadiation
Bladder radiotherapy will be delivered to a total dose of 60-64 Gy in 30-32 fractions, at 2.0 Gy per fraction, once daily, 5 fractions per week, over approximately 6 weeks. Radiotherapy will be initiated concurrently with systemic therapy.
Transurethral Resection of Bladder TumorProcedure or surgery
Participants will undergo maximal transurethral resection of the bladder tumor before combined treatment. Cystoscopic biopsy or diagnostic TURBT will be performed at 8 weeks (±2 weeks) after radiotherapy to assess pathological response.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy | Experimental | Participants will undergo maximal transurethral resection of the bladder tumor, followed by trastuzumab rezetecan at 4.8 mg/kg intravenously every 3 weeks for 4 cycles and adebrelimab at 1200 mg intravenously every 3 weeks for 4 cycles. Bladder radiotherapy will be initiated concurrently with systemic therapy and delivered to a total dose of 60-64 Gy in 30-32 fractions (2.0 Gy per fraction), once daily, 5 fractions per week, over approximately 6 weeks.
At 8 weeks (±2 weeks) after completion of radiotherapy, participants will undergo cystoscopic biopsy or diagnostic transurethral resection of the bladder tumor to assess pathological response. Participants with a pathological stage of T1 or lower (ypT0, ypTa, ypTis, or ypT1) may continue bladder-preserving management and follow-up. Radical cystectomy will be recommended for participants with a pathological stage above T1. Receives: Drug: Trastuzumab Rezetecan; Drug: Adebrelimab; Radiation: Concurrent Bladder Radiotherapy; Procedure: Transurethral Resection of Bladder Tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Pathological Response Rate
The percentage of participants whose pathological stage is downstaged to non-muscle-invasive disease (ypT0, ypTa, ypTis, or ypT1), as confirmed by cystoscopic biopsy or diagnostic transurethral resection of the bladder tumor.
Measured: At 8 weeks (±2 weeks) after completion of radiotherapy
Secondary outcomes (5)
Event-Free Survival (EFS)
Time from treatment initiation to the first occurrence of disease progression precluding surgery, local or distant recurrence, or death from any cause.
Measured: From treatment initiation until the first qualifying event or last disease assessment, up to 33 months
Overall Survival (OS)
Time from signing informed consent to death from any cause.
Measured: From signing informed consent until death or last known alive date, up to 33 months
Bladder Preservation Rate
Percentage of participants who retain their native bladder without undergoing radical cystectomy during the follow-up period.
Measured: From treatment initiation through the end of follow-up, up to 33 months
1-Year and 2-Year Bladder Event-Free Survival Rates
The percentages of participants who retain their native bladder without muscle-invasive recurrence, lymph node or distant metastasis, salvage radical cystectomy, or bladder cancer-related death.
Measured: At 1 year and 2 years after treatment initiation
Incidence and Severity of Adverse Events
The incidence and severity of adverse events and serious adverse events, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0.
Measured: From the first dose of study treatment through 90 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (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 Tongji 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Shaogang Wang, Tongji Hospital
- Investigators
- Shaogang Wang, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865611
- Sponsor's protocol ID
- 26-OBU-HuB-MIBC-II-001
- Acronym
- RG-BP-MIBC
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-Label Phase II Study of Response-Guided Bladder Preservation With Trastuzumab Rezetecan Plus Adebrelimab and Concurrent Bladder Radiotherapy in Patients With HER2-Expressing Muscle-Invasive Bladder Cancer
- ClinicalTrials.gov ID
- NCT07865611
- Acronym / sponsor ID
- RG-BP-MIBC / 26-OBU-HuB-MIBC-II-001
- Conditions
- Muscle-Invasive Bladder Cancer (MIBC)
- Keywords
- HER2-Expressing Bladder Cancer, Bladder Preservation, Trastuzumab Rezetecan, Adebrelimab, Concurrent Radiotherapy, Response-Guided Treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- Sep 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Oct 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 prospective, multicenter, open-label phase II study will evaluate a response-guided bladder-preservation strategy in patients with HER2-expressing muscle-invasive bladder cancer. Participants will receive maximal transurethral resection of the bladder tumor, trastuzumab rezetecan plus adebrelimab, and concurrent bladder radiotherapy. Treatment response will be assessed by cystoscopic biopsy or diagnostic transurethral resection at 8 weeks (±2 weeks) after radiotherapy. Participants with a pathological stage of T1 or lower may continue bladder-preserving management, whereas radical cystectomy will be recommended for participants with disease above T1. The primary outcome is the major pathological response rate.
Detailed description
This is a prospective, multicenter, open-label, single-arm phase II study designed to evaluate the efficacy and safety of a response-guided bladder-preserving strategy using trastuzumab rezetecan plus adebrelimab in combination with bladder radiotherapy in patients with HER2-expressing muscle-invasive bladder cancer (MIBC).
Approximately 70 participants with clinically staged cT2-T4a, N0, M0 MIBC will be enrolled. Eligible participants will undergo maximal transurethral resection of the bladder tumor (TURBT), followed by trastuzumab rezetecan at 4.8 mg/kg intravenously every 3 weeks for 4 cycles and adebrelimab at 1200 mg intravenously every 3 weeks for 4 cycles.
Bladder radiotherapy will be initiated concurrently with systemic therapy and delivered to a total dose of 60-64 Gy in 30-32 fractions, at 2.0 Gy per fraction, once daily, 5 fractions per week, over approximately 6 weeks.
At 8 weeks (±2 weeks) after completion of radiotherapy, participants will undergo cystoscopic biopsy or diagnostic TURBT to assess pathological response. Participants with a pathological stage of T1 or lower (ypT0, ypTa, ypTis, or ypT1) may continue bladder-preserving management with close surveillance. Radical cystectomy will be recommended for participants with residual disease above pathological stage T1.
The primary outcome is the major pathological response rate, defined as the proportion of participants with a pathological stage of T1 or lower at post-radiotherapy assessment. Secondary outcomes include event-free survival, overall survival, bladder preservation rate, 1-year and 2-year bladder event-free survival, and safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy | Experimental | Drug: Trastuzumab Rezetecan, Drug: Adebrelimab, Radiation: Concurrent Bladder Radiotherapy, Procedure: Transurethral Resection of Bladder TumorParticipants will undergo maximal transurethral resection of the bladder tumor, followed by trastuzumab rezetecan at 4.8 mg/kg intravenously every 3 weeks for 4 cycles and adebrelimab at 1200 mg intravenously every 3 weeks for 4 cycles. Bladder radiotherapy will be initiated concurrently with systemic therapy and delivered to a total dose of 60-64 Gy in 30-32 fractions (2.0 Gy per fraction), once daily, 5 fractions per week, over approximately 6 weeks. At 8 weeks (±2 weeks) after completion of radiotherapy, participants will undergo cystoscopic biopsy or diagnostic transurethral resection of the bladder tumor to assess pathological response. Participants with a pathological stage of T1 or lower (ypT0, ypTa, ypTis, or ypT1) may continue bladder-preserving management and follow-up. Radical cystectomy will be recommended for participants with a pathological stage above T1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years, male or female; able to provide written informed consent; willing and able to comply with all protocol-required examinations and follow-up.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Minor squamous, glandular, or other mixed differentiation is permitted. Patients with pure non-urothelial carcinoma may be enrolled at the investigator's discretion.
- Clinical stage cT2-T4a, N0, M0, based on pelvic/abdominal imaging with or without chest imaging.
- HER2 expression of IHC 1+, 2+, or 3+ in tumor tissue, as determined by a central or designated laboratory.
Key exclusion criteria (19 listed)
- 1. Distant metastasis (M1), clearly uncontrollable extra-regional metastatic disease, or an upper urinary tract tumor requiring priority treatment.
- 2. Previous systemic anticancer treatment for the current bladder cancer, including chemotherapy, immunotherapy, anti-HER2 targeted therapy, or antibody-drug conjugates, or previous pelvic radiotherapy that could affect the delivery or safety of study radiotherapy.
- 3. Unable to complete protocol-required local treatment, including inability to undergo maximal TURBT or the presence of a contraindication to radiotherapy, such as previous high-dose irradiation to the same region or active inflammatory bowel disease.
- 4. Active autoimmune disease or a history requiring long-term systemic immunosuppressive treatment, including prednisone ≥10 mg/day or equivalent within 14 days before treatment. Physiologic replacement doses are permitted.
- 5. Active pneumonitis or interstitial lung disease, or a history of severe drug-related pneumonitis.
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 |
|---|---|---|
| Trastuzumab RezetecanTrastuzumab rezetecan will be administered intravenously at a dose of 4.8 mg/kg every 3 weeks for 4 cycles. | Drug | Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy |
| AdebrelimabAdebrelimab will be administered intravenously at a dose of 1200 mg every 3 weeks for 4 cycles. | Drug | Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy |
| Concurrent Bladder RadiotherapyBladder radiotherapy will be delivered to a total dose of 60-64 Gy in 30-32 fractions, at 2.0 Gy per fraction, once daily, 5 fractions per week, over approximately 6 weeks. Radiotherapy will be initiated concurrently with systemic therapy. | Radiation | Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy |
| Transurethral Resection of Bladder TumorParticipants will undergo maximal transurethral resection of the bladder tumor before combined treatment. Cystoscopic biopsy or diagnostic TURBT will be performed at 8 weeks (±2 weeks) after radiotherapy to assess pathological response. | Procedure or surgery | Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy |
Primary outcome
Major Pathological Response Rate
Time frame: At 8 weeks (±2 weeks) after completion of radiotherapy
The percentage of participants whose pathological stage is downstaged to non-muscle-invasive disease (ypT0, ypTa, ypTis, or ypT1), as confirmed by cystoscopic biopsy or diagnostic transurethral resection of the bladder tumor.
5 secondary outcomes
Event-Free Survival (EFS)
Time frame: From treatment initiation until the first qualifying event or last disease assessment, up to 33 months
Overall Survival (OS)
Time frame: From signing informed consent until death or last known alive date, up to 33 months
Bladder Preservation Rate
Time frame: From treatment initiation through the end of follow-up, up to 33 months
1-Year and 2-Year Bladder Event-Free Survival Rates
Time frame: At 1 year and 2 years after treatment initiation
Incidence and Severity of Adverse Events
Time frame: From the first dose of study treatment through 90 days after the last dose
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 8 Oct 2026.
- 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.
Shaogang Wang principal investigator
Tongji Hospital
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 Trastuzumab Rezetecan, Adebrelimab and Concurrent Bladder Radiotherapy in people with Muscle-Invasive Bladder Cancer (MIBC), run by Tongji 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 9 inclusion and 19 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 8 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 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?
Contact Wen Song (+86 18971040867, sgwangtjm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Pathological Response Rate (time frame: At 8 weeks (±2 weeks) after completion of radiotherapy). 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 8 Oct 2026.