Bladder Cancer
Conditions
Interventions
experimental group:intravesical catumaxomab
Sponsors
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Signed and dated informed consent forms have been provided; 2. Willing to be complaint with the study procedures during the study; 3. Male or female, aged >=18 years old when signing informed consents; 4. Histologically or cytologically diagnosed as NMIBC, i.e., bladder cancer in the following pTNM status: pTis, pTa, pT1; 5. Have received the standard therapy recommended in the current NMIBC clinical guidelines, including intravesical BCG instillation, and diagnosed as BCG failure or intolerance; 6. Participants had completed TURBT or cystoscopy as required by guidelines prior to enrollment, and no significant tumours were seen in the surgical field Residual lesions 7. Recovered from any toxicity due to previous treatment (Grade 0-1 according to NCI-CTCAE v 5.0); 8. Estimated life span >=6 months; 9. Eastern Oncology Cooperative Group (ECOG) performance status 0-1. 10. The laboratory test values during the screening period are in accordance with the following table ANC (absolute neutrophil count)>=1.5x10^9/L Hemoglobin>=80 g/LPlatelet>=100x10^9/L Lymphocyte percentage>=20% Serum Bilirubin =30 mL/min; 11. For women of childbearing potential: use an efficient method for contraception (refer detail in Section 11.6) at least 1 month prior to screening and agree to use this method for contraception during the study period and 30 days after the last intravesical instillation; 12. For men with fertility potential: use condoms or other methods (refer detail in Section 11.6) to ensure effective contraception for sexual partners from screening to 30 days after the last intravesical instillation.
Exclusion criteria
Exclusion criteria: 1. Known or suspected of being allergic to catumaxomab or similar antibodies; 2. Besides the TURBT + immediate postoperative infusion chemotherapy participants received other anti-tumor treatments, including other anti-tumor investigational drugs, chemotherapy, immunotherapy, biological agents, hormone therapy, radiation therapy (excluding local radiation therapy for pain relief), etc., the interval between the last instillation and the first intravesical instillation <= 21 days; 3. Tumor metastases outside the bladder confirmed in imaging examination. 4. With other primary malignant tumors diagnosed before the signing of ICF, excluding squamous cell carcinoma in situ of skin or cervical carcinoma in situ without recurrence within 5 years after resection; 5. The following diseases have not been resolved to CTCAE grade 0-1 in 3 days prior to the first instillation: (1) Uncontrolled acute and chronic infections such as pneumonia, biliary infection, hepatitis B virus infection and hepatitis C virus infection, etc.; (2) Dyspnea; (3) Acute /chronic renal injury; (4) Nephrotic syndrome; (5) Bladder perforation; (6) Urinary tract obstruction((except benign prostatic hypertrophy)); 6. NYHA Class 3 or 4; 7. Related symptoms and signs of cardiovascular diseaseshave not been resolved to CTCAE grade 0-1: including myocardial infarction, congestive heart failure, and arrhythmia; 8. Known cerebrovascular accidents have not been resolved to CTCAE grade 0-1; 9. History of autoimmune diseases (eg, inflammatory bowel disease, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autologous hemolytic anemia, rheumatoid arthritis, etc.); 10. Patients with known HIV serology positive, hepatitis C infection and/or hepatitis B (Except the patients with positive HepBsAg or core antibody are responding to anti-HBV treatment, they are allowed to participate in the study. Notes: HepBsAg-negative patients at screening, or patients are undergoing treatment with interferon-2a [IFN] or peginterferon-2a [Peg-IFN] and hepatitis B virus [HBV] DNA < 2000 international units [IU], or patients who are receiving nucleoside [acid] analogues at screening and HBV DNA below the lower limit of normal [LLN] are eligible to participate in the study; 11. Pregnancy or breastfeeding during study treatment and follow-up period; 12. Patients with confirmed past history of neurological or psychotic disorders, including epilepsy or dementia; 13. Other serious systemic conditions that may limit the participation in this study (e.g. uncontrolled diabetes, cardiovascular and cerebrovascular disease, severe gastrointestinal disease, and renal disease, etc.); 14. Any other condition that, in the discretion of the investigator will make patients exposed to unnecessary risks and unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT incidence.;1-year recurrence rate since the initial instillation; | — |
Countries
China
Contacts
Public ContactJian Huang
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Outcome results
None listed