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Clinical Trial NCT05912205 for Urothelial Carcinoma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Disitamab Vedotin Combined With Radiotherapy for Bladder Preservation Phase 2 30
Clinical Trial NCT05912205 is designed to study Treatment for Urothelial Carcinoma. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on 1 July 2023 until the study accrues 30 participants. Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, this study is expected to complete by 1 July 2026. The latest data from ClinicalTrials.gov was last updated on 22 June 2023.
Brief Summary
This is a prospective, open, single center clinical study of vidicizumab combined with local radiotherapy as bladder conserving therapy in patients with muscle invasive bladder urothelium cancer with HER-2 expression (IHC 2+or 3+). A total of 30 subjects were included in the study
Detailed Description
A total of 30 subjects were included in the study. Each subject underwent diagnostic bladder resection (TURBT) and imaging diagnosis, and biological samples such as blood, urine, and biopsy tissue were collected before treatment. After myometrial invasive bladder cancer with HER2 expression (IHC 2+or 3+) judged by pathological tissue, four cycles of neoadjuvant therapy with vedixizumab (2.0mg/kg) was first performed,...Show More
Official Title
An Open, Single Arm, Phase II Clinical Study on the Efficacy and Safety of Bladder Sparing Therapy With Vidixizumab Combined With Local Radiotherapy in Patients With HER-2 Expressing Myometrial Invasive Urothelium Carcinoma
Conditions
Urothelial CarcinomaOther Study IDs
- UHCT221037
NCT ID Number
Start Date (Actual)
2023-07-01
Last Update Posted
2023-06-22
Completion Date (Estimated)
2026-07-01
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalDisitamab Vedotin combined with radiotherapy Disitamab Vedotin (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90 min); Radiotherapy (SBRT, bladder irradiation field with a total dose greater than 50 Gy) | Disitamab Vedotin Four cycles of neoadjuvant therapy with Vidiximab (2.0mg/kg) were administered first, followed by bladder sparing therapy using maximized TURBT combined with radiotherapy and chemotherapy. The patient will receive vidiximab combined with local radiotherapy after maximizing TURBT surgery. The subjects received treatment with Vidixitol every two weeks for six consecutive treatment cycles, and simultaneously received 1 ...Show More radiotherapy radiotherapy |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Bladder-intact event-free survival | 1-year event free survival with intact bladder | 1 year |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Pathologic Complete Response | Neoadjuvant therapy and postoperative pathology confirmed that the primary tumor was in complete remission (stage ypT0) and had no residual tumor cells, regardless of whether the regional lymph nodes were involved or not. | 2 mouths |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- Male or female ≥ 18 years old;
- ECOG PS: 0-1 points;
- 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;
- Clinical staging T2 (CT/MRI+PET/CT);
- Expected survival time ≥ 3 months;
- The immunohistochemical staining result of the tissue after cystoscope or diagnostic electrotomy was IHC 2+or 3+;
- 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.
- 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
- Pregnant or lactating women;
- Positive HIV test results;
- Active hepatitis B or C patients
- Have a clear history of active tuberculosis;
- 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);
- Other serious and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results.
- Urothelium carcinoma of upper urinary tract (urothelium carcinoma of renal pelvis and ureter)
- 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.
Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyStudy Central Contact
Contact: zhang xiaoping, doctor, 027-85726375, [email protected]
Contact: jiang guosong, doctor, 027-85726375, [email protected]
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