Remodeling of MHC-related Immune Microenvironment in MIBC After Neoadjuvant Therapy

NCT07440901 | Not Yet Recruiting

• 1 other identifier: NCC4928
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 select the treatment plan based on relevant biomarkers for subsequent immunotherapy in MIBC patients.

Conditions

Muscle-invasive Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• pCR

  The pathological complete response (pCR) rate evaluated by the pathological laboratory

  immediately after the intervention/procedure/surgery

Interventions

Immunotherapy plus chemotherapy DRUG

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.

Also known as: Immunotherapy combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Muscle-invasive bladder cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine

MeSH Terms

Interventions

Immunotherapy; Drug Therapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Xiongjun Ye

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Xiongjun Ye

CONTACT

13910380916; yexiongjun@cicams.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: February 27, 2026
• Study Start: February 1, 2026
• Primary Completion: May 15, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share