Comprehensive Bladder Preservation Therapy on Patients With Muscle Invasive Bladder Cancer

Launched by FIRST AFFILIATED HOSPITAL XI'AN JIAOTONG UNIVERSITY · Jun 30, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with muscle-invasive bladder cancer, which is a type of bladder cancer that has spread into the muscle layer. The researchers want to see if combining immunotherapy—medications that help the immune system fight cancer—with radiotherapy can effectively preserve the bladder and improve treatment outcomes. This is important because traditional treatments, like certain chemotherapies, may not be suitable for everyone, especially those who can't tolerate them due to side effects.

To participate in this trial, you need to be at least 18 years old and be diagnosed with bladder cancer that meets specific criteria. This includes having a certain stage of cancer confirmed by medical tests. If you join the trial, you can expect to receive the new treatment strategy, which includes immunotherapy before surgery and additional radiotherapy afterward. It's also important to know that there are certain health conditions and previous treatments that could make you ineligible for participation. Overall, this trial aims to find a safer and more effective way to treat bladder cancer while preserving the bladder itself.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years
• • Voluntary participation in this trial, able to provide a written version of informed consent, and able to understand and agree to comply with the requirements of this study.
• • BC patients with cT2-T4aN0M0 tumor/ lymph node/ metastasis (TNM) (AJCC 8th edition) staging based on histopathological confirmation by biopsy specimen and CT/MRI assessment.
• • ECOG performance status grade less than or equal to 1
• Exclusion Criteria:
• • Cancer in situ (CIS) confirmed by biopsy pathology.
• • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein 4(CTLA)-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (excluding BCG treatment).
• • Received other approved systemic anticancer therapy or systemic immunomodulators within 28 days prior to enrollment.
• • Severe chronic or active infection requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment
• • Received herbal or proprietary Chinese medicine for cancer inhibition within 14 days prior to admission.
• • Received live vaccination within 28 days prior to admission.
• • Has need for long-term heavy use of hormones or other immunosuppressive drugs.
• • Potassium, sodium, or calcium abnormalities affecting treatment, interstitial lung disease, non-infectious pneumonia, or other uncontrolled systemic diseases, including diabetes, hypertension, or active heart disease.
• • Patients with chronic hepatitis B, hepatitis B virus carriers, or active hepatitis C.
• • Active, known or suspected autoimmune disease requiring systemic therapy.
• • Patients with end-stage renal disease (GFR \<15 mL/min) or requiring dialysis.
• • Other active neoplastic disease.
• • Uncontrolled severe physical or mental illness.
• • Pregnant or lactating women.