Actively Recruiting
Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer
Led by Fudan University · Updated on 2024-07-12
20
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The trial investigates the use of Disitamab Vedotin combined with Bacillus Calmette-Guerin (BCG) therapy in patients with very high-risk non-muscle invasive bladder cancer (NMIBC) who express the HER2 protein. This study focuses on patients who either refuse or are unsuitable for cystectomy, aiming to evaluate the safety and effectiveness of this combined approach. Conducted under Good Clinical Practice guidelines, the study plans to enroll about 20 participants with HER2 expression levels 1+, 2+, or 3+. Participants will receive Disitamab Vedotin intravenously at a dose of 2.0 mg/kg every three weeks for six months. Alongside this, they will undergo BCG therapy, which includes an induction phase of weekly intravesical treatment for six weeks, followed by maintenance therapy at three, six, and twelve months after surgery, each course administered once weekly for three weeks. The study will monitor outcomes such as event-free survival and complete response rates using cystoscopy, urine cytology, laboratory tests, and imaging. Throughout the study, participants will have cystoscopy and urine cytology every three months for two years, with imaging every six months. After two years, cystoscopy and urine cytology are scheduled every six months, and imaging once a year. Researchers will assess complete response within three months and event-free survival up to six months initially, with further evaluations extending up to five years for progression and overall survival. Safety will be monitored continuously during the study period.
CONDITIONS
Brief Title
Disitamab Vedotin Combined With BCG Therapy in HER2-expressing High-risk Non-muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed non-muscle-invasive urothelial cell carcinoma of the bladder
- Presence of HER2 expression (IHC 1+, 2+, or 3+)
- Very high-risk NMIBC defined by multiple or large T1 tumors, concurrent CIS, micropapillary variant, or CIS in prostatic urethra
- Received first dose of medication within 12 weeks from first TURBT
- Refusal or unsuitability for radical cystectomy
- ECOG performance status of 0 or 1
- Adequate blood and organ function with creatinine clearance ≥30 mL/min
- Signed informed consent
- Negative pregnancy test for females of childbearing potential within 7 days prior to first dose
You will not qualify if you...
- Evidence of muscle-invasive, locally advanced, metastatic, or extravesical bladder cancer
- Upper urinary tract urothelial carcinoma except if disease-free for 2 years after treatment
- Histopathology showing small cell bladder cancer, simple adenocarcinoma, or simple squamous cell carcinoma
- Previous anti-HER2 therapy
- Active malignancy outside the bladder cancer within past 24 months except certain treated skin or breast cancers
- Uncontrolled cardiovascular disease or recent serious heart events within 3 months
- Prolonged QTc interval >480 ms on ECG
- Recent pulmonary embolism or venous thromboembolism within 2 months
- Pregnant or breastfeeding women
- Known HIV infection not stable on therapy or with recent opportunistic infections
- Active hepatitis B or C infection
- Unresolved toxic effects from prior cancer treatments
- Delayed wound healing or major surgery within 4 weeks prior to study start
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 12 months
Participants receive Disitamab Vedotin intravenously every three weeks for 6 months combined with Bacillus Calmette Guerin (BCG) therapy. BCG therapy includes induction with intravesical therapy once a week for 6 weeks, followed by maintenance therapy courses once a week for 3 weeks at 3, 6, and 12 months after surgery.
Weekly visits during BCG induction for 6 weeks, then weekly visits for 3 weeks at months 3, 6, and 12; Disitamab Vedotin infusions every three weeks for 6 months
Duration - Up to 60 months
Participants are monitored with cystoscopy and urine cytology every three months for two years, then every six months thereafter. Radiography occurs every six months for two years, then annually. These assessments evaluate treatment response and detect any recurrence or progression.
Cystoscopy and urine cytology every 3 months for 2 years, then every 6 months; radiography every 6 months for 2 years, then annually
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
Y
Yijun Shen, Doctor
D
Dingwei Ye, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here