Muscle-invasive Bladder CancerNCT07440901
Remodeling of MHC-related Immune Microenvironment in MIBC After Neoadjuvant Therapy
An observational study of Muscle-invasive Bladder Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
In this study, the relevant biomarkers for predicting the efficacy of neoadjuvant therapy in patients with MIBC were further explored. Meanwhile, the dynamic molecular monitoring of neoadjuvant therapy in MIBC patients and the treatment guidance based on the MHC tumor immune microenvironment were also explored to… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Muscle-invasive Bladder Cancer
- What is being tested?
- Immunotherapy plus chemotherapy
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 May 2027
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Muscle-invasive bladder cancer
Who may be able to join
- Male or female, aged ≥18 years.
- Expected survival ≥12 weeks.
- Diagnosed by histopathology as muscle-invasive bladder urothelial carcinoma (MIBC) without upper urothelial carcinoma.
- Clinical stage (cT2-T4a, N0-1, M0) and no distant metastasis as evaluated by imaging.
- The subjects were assessed by urologists as tolerable and planned radical cystectomy.
- ECOG Physical Condition 0-2.
Who cannot join
- Patients with previous malignant tumors were not eligible to participate in the study unless they had achieved complete remission for at least 5 years prior to enrollment and did not require additional treatment or did not require additional treatment during the study.
- Combined with serious internal medical diseases including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc.
- Patients with insufficient communication, understanding and cooperation, or poor compliance, cannot be guaranteed to complete follow-up as required.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Study on the Remodeling of MHC-related Tumor Immune Microenvironment in Patients With Muscle-invasive Bladder Cancer After Neoadjuvant Therapy
In this study, the relevant biomarkers for predicting the efficacy of neoadjuvant therapy in patients with MIBC were further explored. Meanwhile, the dynamic molecular monitoring of neoadjuvant therapy in MIBC patients and the treatment guidance based on the MHC tumor immune microenvironment were also explored to select the treatment plan based on relevant biomarkers for subsequent immunotherapy in MIBC patients.
Read the detailed description
Bladder cancer is one of the most common malignant tumors of the urinary system. Although approximately 70% of newly diagnosed cases are non-muscle-invasive bladder cancer (NMIBC), nearly 90% of them will recur within five years. Once the disease progresses to muscle-invasive bladder cancer (MIBC), the five-year survival rate drops to about 47%, and the rate for distant metastasis is as low as 5%.
Radical cystectomy (RC) is the standard surgical treatment for MIBC. However, Zehnder et al., in a review of surgical cases over 30 years, found that it did not significantly improve survival rates. Over the past two decades, cisplatin-based neoadjuvant chemotherapy has accumulated substantially stronger evidence compared to adjuvant chemotherapy after surgery. One of the largest case studies indicated that neoadjuvant chemotherapy significantly improves the 10-year survival rate. Since May 2016, the U.S. FDA has approved five PD-1/PD-L1 inhibitors for the second-line treatment of advanced urothelial carcinoma, as well as Atezolizumab (IMvigor210, cohort 1) and Pembrolizumab (KEYNOTE-052) for first-line treatment in patients ineligible for cisplatin-based chemotherapy, marking the beginning of a new era in systemic therapy for advanced urothelial carcinoma. With growing understanding of immune mechanisms, clinical research on immunotherapy for bladder cancer has gradually expanded to include combinations with chemotherapy, radiotherapy, targeted therapy, and preoperative neoadjuvant applications. Among these, the results of the PURE-01 and ABACUS studies on neoadjuvant immunotherapy prior to RC are particularly encouraging.
This study prospectively plans to enroll 30 patients with muscle-invasive bladder cancer. These patients will receive standard systemic therapy combined with immunotherapy. The research aims to explore the correlation between the remodeling of the tumor immune microenvironment and patient prognosis and treatment efficacy. Furthermore, there remains a lack of biomarkers for predicting the efficacy of neoadjuvant therapy in MIBC patients. This study will further investigate potential biomarkers for predicting treatment response to neoadjuvant therapy in MIBC patients. It will also explore dynamic molecular monitoring during neoadjuvant treatment and treatment guidance based on the MHC-related tumor immune microenvironment. The ultimate goal is to facilitate treatment selection for MIBC patients receiving immunotherapy based on relevant biomarkers.
- Conditions
- Muscle-invasive Bladder Cancer
- Being tested
- Immunotherapy plus chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunotherapy plus chemotherapyDrug
Also called Immunotherapy combined with chemotherapy
The neoadjuvant therapy regimen for muscle-invasive bladder cancer is the GC regimen. This study does not alter the patients' neoadjuvant therapy regimen but adds toripalimab to the selected neoadjuvant treatment. After MDT discussion, eligible patients will receive GC combined with immunotherapy therapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR
The pathological complete response (pCR) rate evaluated by the pathological laboratory
Measured: immediately after the intervention/procedure/surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion1 May 2027 (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 CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiongjun Ye, Study chair, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440901
- Sponsor's protocol ID
- NCC4928
- Status last verified
- Feb 2026
- First submitted
- 16 Sep 2025
- Last updated
- 27 Feb 2026
- Results posted
- 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 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Remodeling of MHC-related Tumor Immune Microenvironment in Patients With Muscle-invasive Bladder Cancer After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT07440901
- Acronym / sponsor ID
- NCC4928
- Conditions
- Muscle-invasive Bladder Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 27 Feb 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.
In this study, the relevant biomarkers for predicting the efficacy of neoadjuvant therapy in patients with MIBC were further explored. Meanwhile, the dynamic molecular monitoring of neoadjuvant therapy in MIBC patients and the treatment guidance based on the MHC tumor immune microenvironment were also explored to select the treatment plan based on relevant biomarkers for subsequent immunotherapy in MIBC patients.
Detailed description
Bladder cancer is one of the most common malignant tumors of the urinary system. Although approximately 70% of newly diagnosed cases are non-muscle-invasive bladder cancer (NMIBC), nearly 90% of them will recur within five years. Once the disease progresses to muscle-invasive bladder cancer (MIBC), the five-year survival rate drops to about 47%, and the rate for distant metastasis is as low as 5%.
Radical cystectomy (RC) is the standard surgical treatment for MIBC. However, Zehnder et al., in a review of surgical cases over 30 years, found that it did not significantly improve survival rates. Over the past two decades, cisplatin-based neoadjuvant chemotherapy has accumulated substantially stronger evidence compared to adjuvant chemotherapy after surgery. One of the largest case studies indicated that neoadjuvant chemotherapy significantly improves the 10-year survival rate. Since May 2016, the U.S. FDA has approved five PD-1/PD-L1 inhibitors for the second-line treatment of advanced urothelial carcinoma, as well as Atezolizumab (IMvigor210, cohort 1) and Pembrolizumab (KEYNOTE-052) for first-line treatment in patients ineligible for cisplatin-based chemotherapy, marking the beginning of a new era in systemic therapy for advanced urothelial carcinoma. With growing understanding of immune mechanisms, clinical research on immunotherapy for bladder cancer has gradually expanded to include combinations with chemotherapy, radiotherapy, targeted therapy, and preoperative neoadjuvant applications. Among these, the results of the PURE-01 and ABACUS studies on neoadjuvant immunotherapy prior to RC are particularly encouraging.
This study prospectively plans to enroll 30 patients with muscle-invasive bladder cancer. These patients will receive standard systemic therapy combined with immunotherapy. The research aims to explore the correlation between the remodeling of the tumor immune microenvironment and patient prognosis and treatment efficacy. Furthermore, there remains a lack of biomarkers for predicting the efficacy of neoadjuvant therapy in MIBC patients. This study will further investigate potential biomarkers for predicting treatment response to neoadjuvant therapy in MIBC patients. It will also explore dynamic molecular monitoring during neoadjuvant treatment and treatment guidance based on the MHC-related tumor immune microenvironment. The ultimate goal is to facilitate treatment selection for MIBC patients receiving immunotherapy based on relevant biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Muscle-invasive bladder cancer
Key inclusion criteria (6 listed)
- Male or female, aged ≥18 years.
- Expected survival ≥12 weeks.
- Diagnosed by histopathology as muscle-invasive bladder urothelial carcinoma (MIBC) without upper urothelial carcinoma.
- Clinical stage (cT2-T4a, N0-1, M0) and no distant metastasis as evaluated by imaging.
- The subjects were assessed by urologists as tolerable and planned radical cystectomy.
Key exclusion criteria (3 listed)
- Patients with previous malignant tumors were not eligible to participate in the study unless they had achieved complete remission for at least 5 years prior to enrollment and did not require additional treatment or did not require additional treatment during the study.
- Combined with serious internal medical diseases including but not limited to: uncontrolled diabetes, active peptic ulcer, active bleeding, etc.
- Patients with insufficient communication, understanding and cooperation, or poor compliance, cannot be guaranteed to complete follow-up as required.
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 |
|---|---|---|
| Immunotherapy plus chemotherapyAlso: Immunotherapy combined with chemotherapyThe neoadjuvant therapy regimen for muscle-invasive bladder cancer is the GC regimen. This study does not alter the patients' neoadjuvant therapy regimen but adds toripalimab to the selected neoadjuvant treatment. After MDT discussion, eligible patients will receive GC combined with immunotherapy therapy. | Drug | – |
Primary outcome
pCR
Time frame: immediately after the intervention/procedure/surgery
The pathological complete response (pCR) rate evaluated by the pathological laboratory
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 27 Feb 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.
Xiongjun Ye study chair
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Muscle-invasive Bladder Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 6 inclusion and 3 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 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Xiongjun Ye (13910380916, yexiongjun@cicams.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR (time frame: immediately after the intervention/procedure/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 27 Feb 2026.