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A Clinical Trial Evaluating the Efficacy and Safety of Disitamab Vedotin Plus Tislelizumab Combined with Re-TURBT in the Treatment of HER-2-high Expression(2+-3+) Non-muscle Invasive Bladder Cancer At High-risk and Very High-risk.

ConditionNMIBC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFujian Medical University Union Hospital

About this trial

This prospective, multicenter, single-arm phase II trial aims to evaluate the clinical efficacy and safety of the combination therapy of Disitamab Vedotin with Tislelizumab and a second transurethral resection for the treatment of high-risk, very high-risk NMIBC with HER2 2+-3+.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in the experiment and sign a written informed consent form；

Patients should be aged between 18 and 85 years, with no gender restrictions, no severe organ failure such as heart, lung, or brain, and an expected survival period of one year or more;

Complete the relevant screening tests (routine blood test, coagulation function, liver and kidney function, infectious disease screening, 12-lead electrocardiogram, urinary system ultrasound, pelvic enhanced CT or MRI, and tissue pathology examination), and have no contraindications for TURBt surgery;

Eastern Cooperative Oncology Group (ECOG) score: 0-2 points;

Disqualifiers

Any of the following circumstances: those with immune deficiency or impairment (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy, and who may cause systemic BCG disease reaction; Individuals who are allergic to the components of BCG vaccine; Patients with fever and acute infectious diseases, including active tuberculosis, or those receiving anti tuberculosis treatment; Accompanied by severe chronic cardiovascular and cerebrovascular diseases or chronic kidney disease;

Patients with other urogenital system tumors or other organ tumors;

Patients with AUA grading of low-risk, moderate risk NMIBC, or myometrial invasive bladder urothelial carcinoma (T2 stage or above), or immunohistochemistry Her2 negative or 1+patients;

Individuals who have received chemotherapy, radiation therapy, or immunotherapy within the past 4 weeks;

Trial design

Design model

Single group

Treatments tested in this trial

  • Distitamab Vedotin in combination with Tislelizumab

    Drug

    On the day after the initial TURBt procedure, use trastuzumab (200mg)+ Distitamab Vedotin (120mg \[≤ 60Kg\] or 2.0mg/Kg \[\>60Kg\]) every 3 weeks (Q3W). Simultaneously arrange for the patient to complete a second TURBt within 6 weeks, and continue to use 3 courses of Trastuzumab+Vediximab (Q3W) after surgery until the endpoint of 3-year follow-up

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

1-year Event-Free Survival rate

The possibility of patients have not experienced any events for at least 12 months after receiving treatment, including death, disease progression, switch to chemotherapy, addition of other treatments, fatal or intolerable side effects, etc

Time frame
From date of randomization until the date of any event occurrence, whichever came first，assessed up to 12 months

Secondary outcomes

1

3-years Event-Free Survival rate

The possibility of patients have not experienced any events for at least 36 months after receiving treatment, including death, disease progression, switch to chemotherapy, addition of other treatments, fatal or intolerable side effects, etc

Time frame
From date of randomization until the date of any event occurrence, whichever came first，assessed up to 36 months
2

2-year bladder disease-free survival（2 year BIDFS） rate

The probability of patients remaining free from muscle-invasive recurrence, regional lymph node recurrence, distant metastasis, the need for radical cystectomy, or death for at least 24 months after the initiation of treatment

Time frame
From date of randomization until the date of muscle-invasive recurrence, regional lymph node recurrence, distant metastasis, the need for radical cystectomy, or death, whichever came first，assessed up to 24 months
3

Reccurence Free Survival（ RFS）

Time from the first TURBT to the first occurrence of bladder tumor recurrence was recorded by cystoscopy and pathological examination, with the main time points being 1 year, 2 years, and 3 years

Time frame
From date of the first TURBT until the date of bladder tumor recurrence, assessed up to 36 months
4

Overall survival

Time from the start of treatment to death from any causes

Time frame
From date of randomization until the date of death from any cause, assessed up to 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Medical University Union Hospital

Lead sponsor

BeiGene

Collaborator

RemeGen Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: