bladder cancer
Conditions
Interventions
Control group:Disitamab Vedotin targeted therapy combined with Toripalimab Immunotherapy, the regimen is the same as in the zinc?supplemented group.
Zinc supplementation group:Disitamab Vedotin targeted therapy combined with toripalimab immunotherapy and zinc sulfate treatment.
Disitamab Vedotin 2 mg/kg is administered intravenously on Day 1
Toripalimab 160 mg is administered intravenously on Day 1. Each treatment cycle is 2 weeks, for a total of 6–10 cycles. Zinc sulfate 300 mg/day (equivalent to 68 mg of elemental zinc) is given orally,
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged >= 18 years; 2.ECOG performance status (PS): 0–1; 3.Subjects who have undergone transurethral resection of bladder tumor (TURBT) or partial cystectomy, with imaging diagnosis, and are judged by the investigator to have muscle-invasive bladder urothelial carcinoma (urothelial carcinoma as the main pathological component > 50%); 4.HER2 immunohistochemistry (IHC) score of 2+ or 3+; 5.Clinical stage T2–T4a N0 M0 (confirmed by CT/MRI ± PET/CT); 6.Have undergone TURBT or partial cystectomy; 7.Have tissue specimens from TURBT or partial cystectomy available; 8.Expected survival = 3 months; 9.Complete blood count criteria must meet the following (no blood transfusion or granulocyte colony-stimulating factor treatment within 14 days prior to enrollment): HB >= 90 g/L; ANC >= 1.5 × 10? /L. PLT >= 100×10^9 /L; 10.No organic disease with functional impairment, must meet the following criteria: T-BIL 30 ml/min (Cockcroft-Gault formula); international normalized ratio (INR) and activated partial thromboplastin time (aPTT): <= 1.5 × ULN (this criterion applies only to patients not receiving anticoagulant therapy; Patients on anticoagulation should maintain their anticoagulant within the therapeutic range). 11.No systemic corticosteroid therapy within the 4 weeks prior to treatment; 12.Men with reproductive capacity or women with the possibility of pregnancy must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, self-restraint or barrier methods combined with spermicides) during the trial, and continue to use contraception for 12 months after the treatment is completed. 13.For women who may be pregnant, they must have a negative urine pregnancy test result within 7 days prior to the treatment; 14.The subjects voluntarily participated in the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion criteria
Exclusion criteria: 1.Previously received anti-PD-1, anti-PD-L1 and anti-PD-L2 therapies, including in the adjuvant treatment phase; 2.Patients with known allergy to recombinant humanized anti-PD-1 monoclonal antibody and its components; 3.Patients who have received other anti-tumor therapies (including corticosteroid therapy and immunotherapy) or participated in other clinical studies within 4 weeks prior to the initiation of study treatment, or have not recovered from the toxicity of previous treatment (excluding Grade 2 alopecia and Grade 1 neurotoxicity). 4.Pregnant or lactating women; 5.HIV test result positive; 6.Patients with active hepatitis B or hepatitis C:Those positive for HBsAg or HBcAb with detectable HBV DNA (quantitation limit: 500 IU/mL, or the positive threshold adopted by the study site). HBV DNA testing is mandatory during screening for such patients. Patients with positive HCV antibody are eligible for enrollment only if their HCV RNA PCR test yields negative results. 7.With a documented history of active tuberculosis; 8.Patients with active autoimmune diseases requiring systemic therapy within the past 2 years (e.g., treatment with disease-modifying drugs, corticosteroids or immunosuppressive agents). Relevant replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are permitted. 9.Other severe and uncontrolled concomitant diseases that may affect protocol compliance or interfere with result interpretation, including active opportunistic infections or progressive (severe) infections, uncontrolled diabetes mellitus, cardiovascular diseases (New York Heart Association Class III/IV heart failure, second-degree or higher atrioventricular block, myocardial infarction within the past 6 months, unstable arrhythmia or unstable angina pectoris, cerebral infarction within 3 months, etc.) or pulmonary diseases (interstitial pneumonia, obstructive pulmonary disease and history of symptomatic bronchospasm). 10.Received live vaccine administration within 4 weeks prior to treatment initiation. 11.Prior history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 12.Undergoing major surgery within 4 weeks prior to treatment initiation (excluding diagnostic surgery); 13.Patients with a history of psychoactive substance abuse that cannot be discontinued, or a history of psychiatric disorders. 14.Massive pleural effusion or ascites with clinical symptoms or requiring symptomatic treatment; 15.History of other malignant tumors within the past 5 years that have not been cured, excluding obviously cured malignancies or curable cancers such as basal cell carcinoma, squamous cell carcinoma of the skin, localized low-risk prostate cancer, carcinoma in situ of the cervix and breast carcinoma in situ.Note: Patients with localized low-risk prostate cancer (defined as stage <= T2b, Gleason score <= 7, and PSA <= 20 ng/mL at diagnosis if tested) who have received radical treatment and present no biochemical recurrence of prostate-specific antigen (PSA) are eligible for this study. 16.Other severe, acute or chronic medical or psychiatric illnesses or laboratory abnormalities that, in the investigator's opinion, may increase the risks associated with study participation or interfere with the interpretation of study results. 17.Contraindications to zinc supplementation: e.g., hemochromatosis, Wilson's disease, and severe copper deficiency (serum copper < 0.6 mg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum zinc concentration during zinc supplementation treatment;Complete response rate at 3 months after treatment completion.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The 12-month and 24-month overall survival rate of the bladder (BI-EFS);The 12-month and 24-month progression-free survival (PFS) and complete response rate (CR);Safety (adverse events, laboratory tests, and vital signs); | — |
Countries
China
Contacts
Public ContactKe Chen
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Outcome results
None listed