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Disitamab Vedotin Combined With Radiotherapy for Bladder Preservation

Primary Purpose

Urothelial Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Disitamab Vedotin
radiotherapy
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Disitamab Vedotin combined with radiotherapy

    Arm Description

    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)

    Outcomes

    Primary Outcome Measures

    Bladder-intact event-free survival
    1-year event free survival with intact bladder

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    June 12, 2023
    Last Updated
    June 20, 2023
    Sponsor
    Wuhan Union Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05912205
    Brief Title
    Disitamab Vedotin Combined With Radiotherapy for Bladder Preservation
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2025 (Anticipated)
    Study Completion Date
    July 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Wuhan Union Hospital, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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, and then bladder conserving therapy was performed by maximizing TURBT combined with radiotherapy and chemotherapy. The patient will receive vidiximab combined with local radiotherapy after maximizing TURBT surgery. The subjects received a treatment cycle of six consecutive treatment cycles of vidixitol every two weeks, and simultaneously received one month of radiation therapy (SBRT, with a total dose of over 50 Gy in the bladder irradiation field). After completing the above treatment, tumor evaluation will be conducted through imaging and exfoliative cytology. After the completion of radiotherapy, the first tumor efficacy evaluation will be conducted. After the end of radiotherapy, tumor efficacy evaluation will be conducted every 6 weeks. Patients who are not tolerant to radiotherapy (evaluated by the researchers) will directly discontinue the medication.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urothelial Carcinoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Disitamab Vedotin combined with radiotherapy
    Arm Type
    Experimental
    Arm Description
    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)
    Intervention Type
    Drug
    Intervention Name(s)
    Disitamab Vedotin
    Intervention Description
    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 month of radiation therapy (SBRT, total dose of bladder irradiation field greater than 50 Gy)
    Intervention Type
    Radiation
    Intervention Name(s)
    radiotherapy
    Intervention Description
    radiotherapy
    Primary Outcome Measure Information:
    Title
    Bladder-intact event-free survival
    Description
    1-year event free survival with intact bladder
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Pathologic Complete Response
    Description
    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.
    Time Frame
    2 mouths

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    zhang xiaoping, doctor
    Phone
    027-85726375
    Email
    xzhang@hust.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    jiang guosong, doctor
    Phone
    027-85726375
    Email
    499429436@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    zhang xiaoping, doctor
    Organizational Affiliation
    Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    not share

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    Disitamab Vedotin Combined With Radiotherapy for Bladder Preservation

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