Disitamab Vedotin Combined With Radiotherapy for Bladder Preservation

Launched by UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY · Jun 20, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a treatment called Disitamab Vedotin combined with radiation therapy to help preserve the bladder in patients with a specific type of bladder cancer known as muscle-invasive urothelial carcinoma. The study aims to see if this combination can effectively treat cancer while allowing patients to keep their bladder, which is important for maintaining quality of life. The trial is looking for a total of 30 participants who are adults aged 18 and older, have a certain level of cancer severity, and show specific markers in their cancer tissue.

To be eligible for the trial, participants need to have a good overall health status and expected survival of at least three months. They should not have received any other cancer treatments recently, and women must not be pregnant or breastfeeding. If someone joins the study, they can expect to receive the treatment and be closely monitored throughout the process to see how well it works. This trial is currently not recruiting participants yet, but it aims to provide valuable information about a new option for treating bladder cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female ≥ 18 years old;
• • 2. ECOG PS: 0-1 points;
• • 3. Subjects need to receive cystoscope or diagnostic electrotomy, imaging diagnosis, and the investigator judges that it is myometrial invasive bladder urothelium cancer (urothelium cancer is the main pathological component\>50%), and plans to receive comprehensive treatment for bladder preservation;
• • 4. Clinical staging T2 (CT/MRI+PET/CT);
• • 5. Expected survival time ≥ 3 months;
• • 6. The immunohistochemical staining result of the tissue after cystoscope or diagnostic electrotomy was IHC 2+or 3+;
• 7. The main organ function is normal (14 days before enrollment), which meets the following criteria:
• • (1) The blood routine examination standard should meet (no blood transfusion or granulocyte colony-stimulating factor treatment within 14 days before enrollment): HB ≥ 90 g/L; ANC ≥ 1.5 × 109/L; PLT ≥ 100 × 109/L; 8. Have not received systemic corticosteroid therapy within 4 weeks prior to treatment; 9. Men with reproductive ability or women with the possibility of pregnancy must use highly effective contraceptive methods during the trial process and continue to use contraception for 12 months after the end of treatment; 10. The subjects voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up.
• Exclusion Criteria:
• • 1. Those who have received other anti-tumor treatments (including corticosteroid therapy, immunotherapy) or participated in other clinical studies within 4 weeks prior to the start of research treatment, or have not yet recovered from previous toxicity (excluding 2 degree hair loss and 1 degree neurotoxicity
• • 2. Pregnant or lactating women;
• • 3. Positive HIV test results;
• • 4. Active hepatitis B or C patients
• • 5. Have a clear history of active tuberculosis;
• • 6. Active autoimmune diseases that require systematic treatment within the past 2 years (such as the use of disease regulating drugs, corticosteroids, or immunosuppressive drugs), allowing relevant alternative treatments (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for renal or pituitary dysfunction);
• • 7. Other serious and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
• • 8. Urothelium carcinoma of upper urinary tract (urothelium carcinoma of renal pelvis and ureter)
• • 9. According to the researcher's perspective, there may be increased risks associated with participating in the study, or other severe, acute, or chronic medical or mental illnesses or laboratory abnormalities that may interfere with the interpretation of the study results.