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New treatment option for Bladder Cancer
Official title RC48 Combined with Toripalimab As Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients
ClinicalTrials.gov ID: NCT06341400
What this study is testing
What is DisitamabVedotinForIicction Toripalimab?
DisitamabVedotinForIicction Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bladder cancer.
Also referred to as radical cystectomy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A single-arm, prospective, exploratory clinical trial to explore the pathological complete response (pCR) rate of immune checkpoint inhibitors combined with antibody conjugate drugs as the perioperative treatment of platinum-intolerant bladder cancer patients. Fifty-five patients with clinically or pathologically confirmed muscle-invasive bladder urothelial carcinoma (MIBC) who were ineligible for cisplatin-based chemotherapy or refused cisplatin-based chemotherapy were enrolled.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntarily agree to provide written informed consent.
- Male or female, aged ≥18 years old.
- Patients must be ineligible for cisplatin-based chemotherapy or refuse cisplatin-based chemotherapy because of any of the following: Creatinine...
- Patients must be medically suitable for TURBT and RC.
- Pathological examination and immunohistochemical Her-2 (≥1+)
You likely can't join if
- known hypersensitivity to components of recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate or allergic reaction to toripalimab.
- toxicity from previous antineoplastic therapy did not revert to CTCAE grade 0-1 (except grade 2 alopecia).
- pleural or abdominal effusion with clinical symptoms requiring ongoing treatment.
- history of major surgery within 4 weeks of planned initiation of trial treatment.
- received live virus vaccine within 4 weeks after planned initiation of trial treatment.
- currently known active HIV or tuberculosis infection.
See the full eligibility criteria
- Voluntarily agree to provide written informed consent.
- Male or female, aged ≥18 years old.
- Patients must be ineligible for cisplatin-based chemotherapy or refuse cisplatin-based chemotherapy because of any of the following: Creatinine clearance (CrCl) \<60 mL/min, ECOG performance status (PS) 0-1 Creatinine...
- Patients must be medically suitable for TURBT and RC.
- Pathological examination and immunohistochemical Her-2 (≥1+)
- measurable lesions according to RECIST 1.1.
- Adequate organ function, as demonstrated by the following laboratory results within 7 days before study treatment: The heart ejection fraction was ≥50%. Hemoglobin ≥9 g/dL; Absolute neutrophil count ≥ 1.5×109 /L and...
- All female people will be considered to be of reproductive potential unless they are postmenopausal or have been surgically sterilized. Female people of childbearing potential had to consent to the use of highly...
- Be willing to comply with the study access schedule and the prohibitions and restrictions set forth in this Agreement.
- known hypersensitivity to components of recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate or allergic reaction to toripalimab.
- toxicity from previous antineoplastic therapy did not revert to CTCAE grade 0-1 (except grade 2 alopecia).
- pleural or abdominal effusion with clinical symptoms requiring ongoing treatment.
- history of major surgery within 4 weeks of planned initiation of trial treatment.
- received live virus vaccine within 4 weeks after planned initiation of trial treatment.
- currently known active HIV or tuberculosis infection.
- diagnosed as HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.
- there is history or current evidence of any condition, treatment, or laboratory abnormality that the treatment investigator believes may confound the trial results, interfere with the participant's participation...
- history of other malignancies within the past 5 years.
- known central nervous system metastases
- uncontrolled hypertension, diabetes, interstitial lung disease, or chronic obstructive pulmonary disease.
- receiving systemic therapy (e.g., immunomodulatory agents, corticosteroids, or immunosuppressive agents) for autoimmune disease within 2 years before study treatment.
- NYHA class III heart failure.
- pregnancy or lactation.
- were assessed by the investigator as unable or unwilling to comply with the requirements of the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.