Neoadjuvant therapy for bladder cancer patients who can't tolerate cisplatin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of combining immune checkpoint inhibitors with antibody conjugate drugs as a neoadjuvant treatment for patients with muscle-invasive bladder carcinoma (MIBC) who are ineligible for or refuse cisplatin-based chemotherapy. A total of 55 patients will receive RC48-ADC and toripalimab intravenously every two weeks for four cycles before surgery and eight cycles after surgery. The primary goal is to evaluate the pathological complete response (pCR) rate, while secondary goals include assessing safety, disease-free survival, overall survival, and response rates. The study also involves collecting plasma and tumor tissue for further analysis of potential predictive biomarkers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily agree to provide written informed consent.
2. Male or female, aged ≥18 years old.
3. 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 clearance (CrCl) ≥ 60 mL/min, ECOG PS 2 (if the patient is eligible for RC) Hearing impairment ≥ CTCAE level 2 According to CTCAE criteria, neuropathy was ≥ grade 2 The patient declined cisplatin-based chemotherapy
4. Patients must be medically suitable for TURBT and RC.
5. Pathological examination and immunohistochemical Her-2 (≥1+)
6. measurable lesions according to RECIST 1.1.
7. 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 platelet ≥ 100×109 /L; Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5×ULN.
8. All female subjects will be considered to be of reproductive potential unless they are postmenopausal or have been surgically sterilized. Female subjects of childbearing potential had to consent to the use of highly effective contraception. Male subjects of childbearing potential and their female partners had to consent to the use of highly effective contraception.
9. Be willing to comply with the study access schedule and the prohibitions and restrictions set forth in this Agreement.

Exclusion Criteria:

1. known hypersensitivity to components of recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate or allergic reaction to toripalimab.
2. toxicity from previous antineoplastic therapy did not revert to CTCAE grade 0-1 (except grade 2 alopecia).
3. pleural or abdominal effusion with clinical symptoms requiring ongoing treatment.
4. history of major surgery within 4 weeks of planned initiation of trial treatment.
5. received live virus vaccine within 4 weeks after planned initiation of trial treatment.
6. currently known active HIV or tuberculosis infection.
7. diagnosed as HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.
8. 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 throughout the trial, or be inconsistent with the participant's participation.
9. history of other malignancies within the past 5 years.
10. known central nervous system metastases
11. uncontrolled hypertension, diabetes, interstitial lung disease, or chronic obstructive pulmonary disease.
12. receiving systemic therapy (e.g., immunomodulatory agents, corticosteroids, or immunosuppressive agents) for autoimmune disease within 2 years before study treatment.
13. NYHA class III heart failure.
14. pregnancy or lactation.
15. were assessed by the investigator as unable or unwilling to comply with the requirements of the protocol.

Where it's running

• Zhujiang Hospital, Southern Medical University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Abai Xu, doctor — Zhujiang Hospital
• Study coordinator: Abai Xu, doctor
• Email: lc96xab@163.com
• Phone: 18665626790

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Bladder cancer: test a biomarker-guided plan after neoadjuvant therapy

  This phase 2 study tests a biomarker- and response-guided plan to preserve the bladder in patients with muscle-invasive bladder cancer after neoadjuvant therapy.

  Recruiting Phase 2 Fox Chase Cancer Center · Philadelphia, Pennsylvania · NCT07908979

• Sexual health support after bladder cancer treatment

  This project will try sexological support to help adults about 12 months after bladder cancer treatment improve sexual function and intimacy.

  Recruiting University of Aarhus · Aarhus · NCT07339761

• Toripalimab plus BCG bladder instillation after TURBT for high‑risk non‑muscle‑invasive bladder cancer

  This trial will test whether adding toripalimab (a PD‑1 immunotherapy) to BCG bladder instillations after TURBT helps people with high‑risk or very high‑risk non‑muscle‑invasive bladder cancer.

  Recruiting Phase 2 Changhai Hospital · Shanghai, Shanghai Municipality · NCT07307456

• Ureteral stent versus no stent for adults having radical cystectomy with an ileal conduit

  This trial tests whether placing temporary ureteral stents at the time of radical cystectomy with ileal conduit reduces post-operative complications compared with not placing stents in adults having cystectomy for bladder or other pelvic cancers.

  Recruiting Thomas Jefferson University · Philadelphia, Pennsylvania and 1 other locations · NCT07234968

• Assessing late images in PET-CT for bladder cancer staging

  This study is testing if taking later images during a PET-CT scan can help better identify lymph node involvement in patients with muscle-invasive bladder cancer.

  Recruiting Hopital Foch · Suresnes, Île-de-France Region · NCT06537960

• Combining enfortumab vedotin and pembrolizumab with radiation for muscle invasive bladder cancer

  This study is testing a new combination of a drug and radiation therapy to see if it helps people with muscle invasive bladder cancer who want to avoid surgery.

  Recruiting Phase 1/2 University of California, San Francisco · San Francisco, California · NCT06470282

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.