An interventional study of Whole-dose radiotherapy and Conventional fractionated radiotherapy in Breast Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Not applicable, Interventional, and Treatment
Among 58 studies in Breast Neoplasms by Tianjin Medical University Cancer Institute and Hospital — 33 open to participants now, 33 under way, 1 of them phase 3. Breast Neoplasms · Tianjin Medical University Cancer Institute and Hospital.
Among the 58 studies in Breast Neoplasms by Tianjin Medical University Cancer Institute and Hospital, this one has the largest planned enrollment of the 42 interventional ones that give a count, is one of 10 that started in 2026, is one of 15 with no phase, reaches primary completion later than 21 of the 32 other live ones, and was the 58th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →33 of the 58 studies in Breast Neoplasms by Tianjin Medical University Cancer Institute and Hospital are open now, in 3 countries. Recruiting first, the newest first:
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75 · Women only
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75 · Women only
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18+
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18–75 · Women only
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Ages 18+
By country, each count listing its studies:
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 75 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
58 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 21 · Phase 3 6 · Phase 4 2
First in 2012; this study’s year is marked. 10 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 960 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 105 across the 42 interventional studies, 373 across the 16 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
This tab as a report to print or save as PDF → With an account.
Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 494 studies on the registry; 293 are open to participants now.
6 of the studies in Breast Neoplasms by Tianjin Medical University Cancer Institute and Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06498154Tianjin Medical University Cancer Institute and HospitalEliminating Breast Surgery for Breast Cancer Patients With Clinical Complete Response to Neoadjuvant Systemic Therapy | 2026-12-30 |
| NCT07254416Tianjin Medical University Cancer Institute and HospitalA Study on Nausea and Vomiting Caused by T-DXd in Breast Cancer Patients | 2026-12-31 |
| NCT07708194Tianjin Medical University Cancer Institute and HospitalEntinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab Failure | 2027-02 |
| NCT07831889Tianjin Medical University Cancer Institute and HospitalHypofractionated Radiotherapy After Breast Reconstruction for Breast Cancer | 2027-04-01 |
| NCT07026292Tianjin Medical University Cancer Institute and HospitalSupermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema | 2027-05-31 |
Add all 6 to your calendar (.ics) → With an account.
Among the 58 studies in Breast Neoplasms by Tianjin Medical University Cancer Institute and Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to systematically evaluate the efficacy and safety of this innovative integrated treatment model in patients with muscle-invasive bladder cancer (MIBC). By prospectively observing the clinical complete response rate, bladder relapse-free survival, overall survival, and the incidence and severity of treatment-related adverse events, we hope to clarify the clinical effectiveness of this model and provide a potentially novel and highly effective bladder-preserving approach for MIBC. A comprehensive assessment of its safety profile will provide a basis for patient management and risk control in clinical practice. We will also explore potential biomarkers, such as PD-L1 expression and tumor mutational burden, with the aim of enabling more precise selection of treatment regimens in the future. The successful implementation of this study is expected to bring about an important transformation in the treatment paradigm for MIBC, maximizing the preservation of organ function and quality of life while pursuing optimal oncologic outcomes, and thus holding significant social benefits and value for clinical promotion.
Muscle-invasive bladder cancer (MIBC) accounts for approximately 25% of bladder cancers and carries a high risk of invasion and metastasis. Its 5-year overall survival (OS) is approximately 50%, significantly lower than the 90% observed in non-muscle-invasive bladder cancer. Radical cystectomy (RC) combined with pelvic lymph node dissection is the standard treatment for MIBC; however, the procedure is highly invasive, and more than 60% of patients experience postoperative complications, making bladder-preserving therapy an important alternative.
Trimodality therapy (TMT) is currently the preferred bladder-preserving strategy recommended by guidelines. Its core consists of maximal transurethral resection of bladder tumor (TURBT) followed by concurrent chemoradiotherapy (CRT). Large meta-analyses have shown no significant differences between TMT and RC in 10-year OS (30.9% vs 35.1%) or disease-specific survival (50.9% vs 57.8%), and patients treated with TMT recover quality of life more rapidly and achieve higher quality-adjusted life years. The RTOG series of studies established the role of TMT, but the overall success rate of conventional TMT is only about 50%, leaving nearly half of patients at risk of suboptimal response or the need for salvage cystectomy.
The emergence of immunotherapy has provided new opportunities to optimize TMT. Bladder cancer has a high mutational burden, and PD-L1 expression increases with stage, laying the foundation for immunotherapy. Radiotherapy and immunotherapy act synergistically, inducing immunogenic cell death in tumor cells and activating the abscopal effect. The ReBirth study showed that neoadjuvant immunotherapy followed by concurrent chemoradiotherapy and immunotherapy maintenance achieved a 1-year bladder-preservation event-free survival rate of 86.9%. The HOPE-02 study used neoadjuvant chemotherapy combined with tislelizumab followed by sequential local radiotherapy, achieving 3-year PFS and OS rates of 76% and 81%, respectively, significantly superior to historical data, with all patients who completed radiotherapy achieving complete clinical response.
Advances in radiotherapy technology have also supported bladder-preserving therapy. The 5-year intravesical local recurrence rate of conventional TMT reaches 39%, suggesting that local dose may be insufficient. Hypofractionated radiotherapy (e.g., 55 Gy/20 fractions) is non-inferior to conventional fractionation in terms of local control and toxicity. Stereotactic body radiotherapy (SBRT) enables high-precision, high-dose local control. A study from Peking University showed that SBRT boost combined with whole-pelvis conventional radiotherapy achieved a 98.5% complete response rate in 68 patients with MIBC, with a 2-year OS of 84.5%, successful bladder function preservation in 86.3% of patients, and low rates of severe toxicity.
Against this background, we propose an innovative strategy: combining neoadjuvant chemotherapy (NAC) with immune checkpoint inhibitors as "intensive induction therapy," followed by concurrent chemoradiotherapy combined with immunotherapy maintenance as "intensive consolidation therapy." Currently, international studies on the full-process bladder-preserving model of "NAC + immunotherapy" induction followed by "CRT + immunotherapy" consolidation are still in the early exploratory stage, with a particular lack of high-quality evidence in Chinese populations. Whether improved efficacy is accompanied by unacceptable cumulative toxicity is the key to the clinical application of this model.
Project Overview:
Research Objective:
This study aims to systematically evaluate the efficacy and safety of this innovative integrated treatment model in patients with muscle-invasive bladder cancer (MIBC). By prospectively observing the clinical complete response rate, bladder-preservation-free survival, overall survival, and the incidence and severity of treatment-related adverse events, we hope to clarify the clinical effectiveness of this model and provide a potentially novel and highly effective bladder-preserving approach for MIBC. A comprehensive assessment of its safety profile will provide a basis for patient management and risk control in clinical practice. We will also explore potential biomarkers (such as PD-L1 expression and tumor mutational burden) in the hope of achieving more precise selection of treatment regimens in the future. The successful implementation of this study is expected to bring about an important transformation in the treatment paradigm for MIBC, maximizing the preservation of organ function and quality of life while pursuing optimal oncologic outcomes, and thus holding significant social benefits and value for clinical promotion.
Study Population:
(1) Subjects who voluntarily sign the informed consent form, understand the nature, purpose, and procedures of this trial, and voluntarily comply with the trial requirements; (2) male or female subjects aged 18-85 years; (3) patients with pathologically confirmed MIBC; (4) patients who meet the criteria for neoadjuvant treatment of MIBC and have not previously received tumor-related treatment; (5) patients with clinical tumor staging of cT2-T4aN0M0; (6) male subjects or females who may become pregnant must use highly effective contraception during the trial. Highly fertile males or females who may become pregnant must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, libido-suppressing methods, or contraceptive methods combined with spermicides) during the trial, use contraceptive methods combined with spermicides at the end of treatment, and continue contraception for 12 months after treatment ends; (7) major organ function must meet the following criteria: 1) absolute neutrophil count ≥1.5×10\^9/L; 2) platelet count ≥90×10\^9/L; 3) hemoglobin ≥90 g/L; 4) serum creatinine ≤1.5 times the upper limit of normal (ULN); 5) serum total bilirubin ≤1.5 times the ULN (except in subjects with Gilbert syndrome); 6) aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤1.5 times the ULN; 7) international normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5 times the ULN. (8) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; (9) individuals who wish to preserve the bladder.
Treatment Plan:
This is a single-arm clinical trial observing the efficacy and safety of SBRT after neoadjuvant immunotherapy combined with chemotherapy induction treatment in MIBC. A total of 36 MIBC patients meeting the trial criteria are planned to be enrolled in this study.
Neoadjuvant treatment: MIBC patients enrolled in this study will receive neoadjuvant immunotherapy combined with chemotherapy according to the 2025 Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Bladder Cancer.
Maximal TURBT; induction treatment: serplulimab combined with gemcitabine and cisplatin/carboplatin for a total of 2 cycles; concurrent chemoradiotherapy after completion of 2 cycles of induction treatment; one course of SBRT radiotherapy: primary bladder tumor region/tumor bed, 25 Gy/5 Gy/5 fractions; second course of external beam radiotherapy: bladder radiotherapy (45 Gy/1.8 Gy/25 fractions); cystoscopy and TURBT; maintenance treatment.
Imaging (tumor assessment) time points: during the induction treatment period, 1 month after completion of radiotherapy, 3 months after completion of radiotherapy, every 3 months during the first 2 years of follow-up, and every 6 months from years 3 to 5. Imaging modalities: Pelvic MRI or chest/abdomen/pelvis CT or whole-body superficial lymph node ultrasound. If clinically indicated, imaging of other body sites and/or FDG-PET may be performed.
Efficacy assessment:
A clinical trial evaluating the efficacy and safety of SBRT after neoadjuvant immunotherapy combined with chemotherapy induction therapy for MIBC, including patient efficacy and safety assessments, etc.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The radiotherapy plan for the large-dose fractionation group: 45 Gy / 15 fractions / 3 weeks
Radiation: Whole-dose radiotherapy
Conventional fractionated radiotherapy plan: 50 Gy / 25 fractions / 5 weeks
Radiation: Conventional fractionated radiotherapy
The radiotherapy plan for the large-dose fractionation group: 45 Gy / 15 fractions / 3 weeks
Conventional fractionated radiotherapy plan: 50 Gy / 25 fractions / 5 weeks
Local Control Rate
Local recurrence rate: Regular imaging examinations (such as mammography, MRI, and ultrasound) are conducted to monitor the recurrence of tumors in the breast area. Local recurrence is typically defined as the reappearance of a lump at the original tumor site or in the breast reconstruction area, or as confirmed malignant tumor cells through biopsy.
Time frame: 5year
Complications after breast reconstruction surgery
Post-operative complications of breast reconstruction refer to the core complications that affect the survival of the reconstruction, lead to a second operation, or seriously affect the quality of life of the patient. The observation period is within 2 years. The removal of the implant or the occurrence of capsular contracture ≥ Baker grade III, the rate of severe capsular contracture: This is the most significant physical failure mode of pseudo-weight reconstruction. Reconstruction failure rate: Requires a second operation to remove the implant or replace the flap.
Time frame: 2year
No study locations are listed for this record.
Plan to share: No — The individual participant data (IPD) will not be shared to protect the confidentiality of the patients, and in accordance with the institutional data protection policy.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Apr 2027, 4 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 4 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Dec 2026, on Nov 12, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Tianjin Medical University Cancer Institute and Hospital →