A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.

Launched by FUJIAN MEDICAL UNIVERSITY UNION HOSPITAL · Oct 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment approach for patients with a specific type of bladder cancer called non-muscle invasive bladder cancer (NMIBC) that is at high or very high risk of returning. The study will test a combination of two medications, Disitamab Vedotin and Tislelizumab, along with a second surgery to remove any remaining cancer cells. The goal is to see how effective and safe this treatment is for patients whose cancer shows high levels of a protein called HER2.

To participate in this trial, individuals must be between 18 and 85 years old and have been diagnosed with high or very high-risk NMIBC. They should have had a recent surgery to remove the tumor and have certain health conditions under control, including no severe organ failures. Participants will undergo several tests to ensure they are suitable for the study. Those who join will help researchers learn more about this potential treatment and will be closely monitored throughout the trial to ensure their safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Voluntarily participate in the experiment and sign a written informed consent form；
• • Patients should be aged between 18 and 85 years, with no gender restrictions, no severe organ failure such as heart, lung, or brain, and an expected survival period of one year or more;
• • Complete the relevant screening tests (routine blood test, coagulation function, liver and kidney function, infectious disease screening, 12-lead electrocardiogram, urinary system ultrasound, pelvic enhanced CT or MRI, and tissue pathology examination), and have no contraindications for TURBt surgery;
• • Eastern Cooperative Oncology Group (ECOG) score: 0-2 points;
• • Previous systemic therapy without systemic immunity/ADC drugs；
• • Histologically confirmed non muscle invasive bladder cancer (NMIBC), with or without carcinoma in situ (CIS), the main pathological type is urothelial carcinoma, including other specific histopathological types, but urothelial carcinoma dominates (at least 50%). Patients with AUA classification of high-risk and extremely high-risk recurrence or progression risk by the American Urological Association, and with immunohistochemical results of Her2 being 3+or 2+, who have undergone maximal TURBt within 6 weeks.
• Exclusion Criteria:
• • Any of the following circumstances: those with immune deficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy, and who may cause systemic BCG disease reaction; Individuals who are allergic to the components of BCG vaccine; Patients with fever and acute infectious diseases, including active tuberculosis, or those receiving anti tuberculosis treatment; Accompanied by severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease;
• • Patients with other urogenital system tumors or other organ tumors;
• • Patients with AUA grading of low-risk, moderate risk NMIBC, or myometrial invasive bladder urothelial carcinoma (T2 stage or above), or immunohistochemistry Her2 negative or 1+patients;
• • Individuals who have received chemotherapy, radiation therapy, or immunotherapy within the past 4 weeks;
• • Pregnant or lactating women, women of childbearing age who have not taken effective contraceptive measures, and those planning to conceive during the trial period (including male subject partners);
• • Patients with severe urethral stricture who cannot undergo cystoscopy, those with a history of bladder contracture or functional bladder volume less than 100mL;
• • Patients with various mental disorders, severe coagulation function, liver and kidney function, hematopoietic dysfunction, etc. who cannot tolerate surgical treatment;
• • Participated in clinical trials of other drugs within the past 3 months prior to enrollment;
• • Known opioid or alcohol dependent individuals;
• • Researchers believe that there may be any situation that increases the risk to participants or interferes with the execution of clinical trials.