RC48 Combined with Toripalimab As Neoadjuvant Therapy for Cisplatin Ineligible MIBC Patients

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.