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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 population

Muscle-invasive bladder cancer

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

pCR

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

Time frame
immediately after the intervention/procedure/surgery

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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