Urothelial cancer
Conditions
Interventions
Treatment group:Disitamab Vedotin + Toripalimab + Cisplatin/Carboplatin
Sponsors
Beijing Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Voluntary enrolment and signing of a written informed consent form; 2) Age >=18 years; gender not restricted; 3) Expected survival >= 12 weeks; 4) Histopathologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma, including urothelial carcinoma of the bladder, ureter, renal pelvis and urethra; 5) No prior systemic chemotherapy for locally advanced or metastatic urothelial carcinoma; no disease progression or recurrence within 6 months of completion of neoadjuvant/adjuvant therapy; 6) Measurable lesions as defined by RECIST v1.1 criteria; 7) The investigator deems the patient suitable for treatment with cisplatin or carboplatin; for subjects who cannot tolerate cisplatin, carboplatin chemotherapy will be used. Criteria for cisplatin intolerance (meet any one of the following): eGFR = Grade 2; ECOG performance status >= 2; NYHA heart failure class > 2; 8) HER2 immunohistochemistry (IHC) results are IHC 1+, 2+ or 3+; the subject is able to provide a specimen from the primary tumour site or metastatic site for testing; previous test results (confirmed by the investigator) are also acceptable; 9) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0–1; 10) Normal function of major organs, i.e. meeting the following criteria: Left ventricular ejection fraction (LEVF) >= 50%; New York Heart Association (NYHA) class = 90 g/L; b) Absolute neutrophil count (ANC)>= 1.5 × 10^9/L; c) White blood cell count >= 3.0 × 10^9/L; d) Platelet count >=100 × 10^9/L; Biochemical blood tests (no albumin administered within 14 days prior to screening): a) Albumin >= 28 g/L; b) Total bilirubin =30 mL/min; Coagulation function: a) International Normalised Ratio (INR) or prothrombin time (PT) = 1.5 × ULN; b) Activated partial thromboplastin time (APTT) <= 1.5 × ULN. Urinary protein <= 1+ or 24-hour (h) urinary protein quantification < 1.0 g. 11) Female subjects must be surgically sterilised, postmenopausal, or agree to use at least one medically approved method of contraception (e.g. intrauterine device, oral contraceptives or condoms) during the study treatment period and for 6 months following the end of the study treatment period; a blood pregnancy test must be negative within 7 days prior to study enrolment, and subjects must not be breastfeeding. Male subjects must agree to use at least one medically approved method of contraception (e.g. condoms) during the study treatment period and for 6 months following the end of the study treatment period; 12) Be able to understand the trial requirements and be willing and able to comply with the trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1) A history of malignancy other than urothelial carcinoma, except in the following three circumstances: a) The patient has received potentially curative treatment and there has been no evidence of the disease for 5 years; b) Successful surgical resection of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, or other in situ carcinomas; c) Patients with localised low-risk prostate cancer (defined as stage 325 mg/day) or other antiplatelet agents (e.g. clopidogrel, ticlopidine, dipyridamole) within 10 days prior to the first dose or currently; d) The subject is currently receiving anticoagulant therapy, but the anticoagulant dose has not been stable for more than 2 weeks prior to the first dose; e) Underwent a local invasive procedure (e.g. core needle biopsy) within 1 week prior to the first dose, excluding the placement of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Progression-free survival;Disease control rate;Duration of response; | — |
Countries
China
Contacts
Public ContactJun Guo
Beijing Cancer Hospital
Outcome results
None listed