Disitamab Vedotin Combined With Radiotherapy for Bladder Preservation

NCT05912205 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: UHCT221037
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Bladder-intact event-free survival

  1-year event free survival with intact bladder

  1 year

Secondary Outcomes (1)

• Pathologic Complete Response

  2 mouths

Study Arms (1)

Disitamab Vedotin combined with radiotherapy

EXPERIMENTAL

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)

Drug: Disitamab Vedotin; Radiation: radiotherapy

Interventions

Disitamab Vedotin DRUG

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)

Disitamab Vedotin combined with radiotherapy

radiotherapy RADIATION

radiotherapy

Disitamab Vedotin combined with radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

disitamab vedotin; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• zhang xiaoping, doctor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

Central Study Contacts

zhang xiaoping, doctor

CONTACT

027-85726375; xzhang@hust.edu.cn

jiang guosong, doctor

CONTACT

027-85726375; 499429436@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share