Study on ONCOFID-P-B (Paclitaxel-Hyaluronic Acid) for Bladder Cancer

Inclusion Criteria

• Must be 18 years or older and able to give written consent.
• Have a confirmed diagnosis of a specific type of bladder cancer (CIS) with or without other related tumors, and no cancer spread to other parts of the body.
• Have not responded to BCG therapy and are not suitable for or refuse bladder removal surgery.
• Have had complete removal of certain bladder tumors before starting the study.
• Be in good general health with specific blood and organ function levels.
• Women must not be pregnant and agree to use effective birth control during the study.
• Men must agree to use effective birth control if their partners can become pregnant.
• Be willing to follow the study schedule and procedures.

Exclusion Criteria

• Have or had muscle-invasive bladder cancer or cancer that has spread.
• Allergic to paclitaxel or any ingredients in ONCOFID-P-B.
• Have or had cancer in the upper urinary tract or prostate.
• Have had systemic therapy for bladder cancer.
• Have had bladder treatments within 4 weeks before the study, except certain allowed treatments.
• Have a urinary tract infection that hasn't been treated.
• Have had major surgery within 4 weeks before the study.
• Have had other cancers within the last 5 years, except certain skin or prostate cancers.
• Have serious health conditions that prevent bladder treatments.
• Are participating in another clinical trial.
• Have substance or alcohol abuse issues.
• Have other severe health conditions that could affect study participation.
• Are pregnant, breastfeeding, or not willing to use birth control.
• Have a heart condition that affects the QT interval on an ECG.
• In France, certain legal or social conditions may exclude participation.