Carcinoma of bladder
Conditions
Interventions
YH01 injection initial dose group:YH01 injection initial dose, once a week, 6 times
YH01 injection high dose group:YH01 injection high dose, once a week, 6 times
Sponsors
The First Medical Center of the Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients may enter the trial only if they meet all of the following criteria: (1) Male or female patients =18 years of age at the time of signing the ICF. (2) Patients with moderate or high risk non-invasive bladder cancer (including Ta, T1, and/or Tis) confirmed by clinical cystoscopy, urine cytology, and histopathology within 12 weeks prior to initial administration. (3) BCG vaccine (BCG) does not respond (including BCG refractory and BCG recurrence) and is not suitable for or unwilling to undergo radical cystectomy (4) TURBT (with secondary resection if necessary) was received from 2 months before first administration to 2 weeks before first administration (-60 to -14 days), and all tumors were not visible. (5) ECOG score 0-2 points. (6) Expected survival time =12 months. (7) Sufficient hematology and end-organ function, as defined by the following laboratory test results, which should be obtained within 7 days prior to the first administration of the test drug: Blood system (no blood transfusion or hematopoietic stimulating factor treatment within 14 days) ANC =2 ×109/L PLT =100×109/L Hemoglobin (Hb) =90 g/L Liver function Total bilirubin (TBIL) =1.5× Upper Limit of Normal (ULN) Alanine aminotransferase (ALT) =2.5×ULN; Aspartate aminotransferase (AST) =2.5×ULN; renal function Creatinine =1.5×ULN; Creatinine clearance (Ccr) =50 mL/min (calculated according to the Cockcroft-Gault formula, Ccr is calculated only when creatinine >1.5×ULN) Coagulation function Activated partial thromboplastin time (APTT) =1.5×ULN International Normalized ratio (INR) or prothrombin time (PT) =1.5×ULN (8) Female patients who are not pregnant and lactating, and male patients who have no birth plan within 1 year. (9) Understand and voluntarily sign an informed consent form (ICF), and have the willingness and ability to complete regular visits, treatment plans, laboratory tests, and other testing procedures required by the program.
Exclusion criteria
Exclusion criteria: Patients cannot participate in this clinical trial if they meet any of the following conditions: (1) Myoinvasive bladder cancer (T2-T4) was diagnosed. (2) Patients with upper and lower urothelial carcinoma, lymph node metastasis or distant metastasis. (3) Indwelling ureteral stent or history of vesicoureteral reflux disease. (4) Patients with bladder perfusion contraindications, such as TURBT within 2 weeks after surgery, TURBT perforation after surgery, symptomatic urinary tract infection, and gross hematuria. (5) Except for perfusion after TURBT surgery, others meeting any of the following criteria: • Received nitrosourea or mitomycin C treatment within 6 weeks prior to first use of the trial drug; • Received oral fluorouracil, small-molecule targeted drugs, and Chinese/proprietary medicines with anti-tumor indications within 2 weeks prior to the first use of the trial drug or within 5 half-lives of the drug, whichever is longer; • Received non-CNS palliative radiotherapy within 2 weeks prior to first administration of the investigational drug; • Patients who have received systemic corticosteroids (prednisone >10 mg/ day or equivalent doses of similar drugs) or other immunosuppressive therapy within 2 weeks prior to the first use of the study drug; Treatment with topical, ocular, intra-articular, intranasal, and inhalation corticosteroids or short-term use of corticosteroids for preventive treatment (such as prevention of hypersensitivity to contrast media) are excluded; • Received any other antitumor therapy, including surgery, ethanol injection, radiofrequency ablation, transarterial chemoembolization, intrahepatic chemotherapy, chemotherapy, biotherapy, immunotherapy, hormonal or radiotherapy (except palliative radiotherapy), in the 4 weeks prior to the first administration of the investigational drug. (6) malignancies other than the test tumor species within 5 years prior to the first use of the trial drug, other than local cancers that have been clearly cured or have been free of disease for at least 5 years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or ductal carcinoma in situ of the breast. (7) The adverse reactions of previous anti-tumor therapy have not returned to the NCI CTCAE v5.0 rating = Class 1 (except for the toxicity of alopecia and grade 2 neurotoxicity caused by previous platinum treatment that the researchers judged to have no safety risk). (8) Participate in another therapeutic clinical trial within 4 weeks before the first use of the investigational drug or during the planned trial period. (9) Live attenuated vaccine has been administered within 4 weeks prior to the first administration of the investigational drug. (10) Major surgery or severe trauma occurred within 4 weeks prior to the first use of the investigational drug, or major surgery is expected to occur during the trial period (the definition of major surgery is referred to the Level 3 and 4 surgeries stipulated in the Administrative Measures for Clinical Application of Medical Technology, which came into force on November 1, 2018), and before the first use of the investigational drug, All surgical or major trauma-related aes have not returned to CTCAE v5.0= grade 1 or baseline levels. (11) Virological examination: hepatitis B virus surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) quanti
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;Duration of reaction;Recurrence-free survival;Survival without radical resection;Progression free survival;Incidence of radical cystectomy;Overall survival;Biodistribution characteristics and virus excretion;immunogenicity; | — |
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxic events;Adverse event;Physical examination;Vital sign;Evaluation of urinary tract symptoms;Eastern Oncology Collaboration Group (ECOG) score;Blood routine examination;urinalysis;Blood biochemistry;Blood clotting tests;Pregnancy test;Serological detection of virus;12-lead electrocardiogram;Imaging examination;cystoscopy;histopathology; | — |
Countries
China
Contacts
Public ContactZhang Xu
The First Medical Center of the Chinese People's Liberation Army General Hospital
Outcome results
None listed