Muscular Invasive Bladder Cancer (MIBC)
Conditions
Brief summary
In phase II, the main objective is to evaluate the efficacy of SHR-A2102 combined with Adebrelimab in the treatment of muscular invasive bladder cancer (MIBC); The main objective of phase III is to evaluate the efficacy of SHR-A2102 for injection combined with Adebrelimab compared with gemcitabine combined with cisplatin in the treatment of muscular invasive bladder cancer (MIBC).
Interventions
DRUGSHR-A2102；Adebrelimab
Treatment with SHR-A2102 in combination with fixed dose Adebrelimab
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- 1.18-80 years old, gender not limited. 2.The patient voluntarily joined this study and signed informed consent 3.ECOG score is 0 or 1 4.Expected survival period ≥ 2 years. 5.Pathology and imaging diagnosis of non metastatic muscle invasive bladder cancer 6.There are assessable lesions that meet the RECIST 1.1 criteria 7. Enough organ function
Exclusion criteria
1. Received systemic anti-tumor therapy 4 weeks before starting the study treatment 2. The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level 3. Subjects known or suspected to have interstitial pneumonia 4. Individuals with any active, known or suspected autoimmune diseases 5. There are clinical symptoms or diseases of the heart that have not been well controlled 6. Diagnosed with any other malignant tumor 7. Subjects who have experienced severe infections within 28 days prior to their first medication use 8. History of immunodeficiency 9. Use of attenuated live vaccine within 28 days prior to the first study medication 10. Have undergone major surgery within 28 days prior to the first administration of medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase II: pCR evaluated by researchers; | Three months after the last subject underwent RC+PLD surgery |
| Phase III: EFS assessed by BICR； | 5 years after the first medication of the last subject |
Secondary
| Measure | Time frame |
|---|---|
| ORR | from first dose to disease progression or death, whichever comes first, up to 3 years |
| DCR | from first dose to disease progression or death, whichever comes first, up to 3 years |
| pCR | Three months after MIBC surgery |
| EFS | from first dose to disease progression or death, whichever comes first, up to 3 years |
| DFS | from first dose to disease progression or death, whichever comes first, up to 3 years |
| OS | from first dose to disease progression or death, whichever comes first, up to 3 years |
| R0 resection rate | One month after the last subject underwent RC+PLD surgery |
| AE | from Day1 to 90 days after last dose |
Countries
China
Contacts
CONTACTXiaoxue Pi
Outcome results
None listed