Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
- 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).
- Short title
- Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
- Official title
- A Randomized, Open, Multicenter Phase II/III Clinical Study of SHR-A2102 for Injection Combined With Adebrelimab (SHR-1316) in Perioperative Treatment of Muscular Invasive Bladder Cancer (MIBC)
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2/Phase 3
- Study type
- Interventional
- Completion date
- 2031-12-01
- First posted
- 2025-03-17
- Registry last updated
- 2026-07-13
- Primary completion date
- 2031-12-01
- Start date
- 2025-04-25
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06879145
- ClinicalTrials.gov ID
- NCT06879145
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
Phase II: pCR evaluated by researchers;
Timeframe: Three months after the last subject underwent RC+PLD surgery
Phase III: EFS assessed by BICR；
Timeframe: 5 years after the first medication of the last subject
ORR
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
DCR
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
pCR
Timeframe: Three months after MIBC surgery
EFS
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
DFS
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
OS
Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years
R0 resection rate
Timeframe: One month after the last subject underwent RC+PLD surgery
AE
Timeframe: from Day1 to 90 days after last dose
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
- 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
- Received systemic anti-tumor therapy 4 weeks before starting the study treatment
- The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level
- Subjects known or suspected to have interstitial pneumonia
- Individuals with any active, known or suspected autoimmune diseases
- There are clinical symptoms or diseases of the heart that have not been well controlled
- Diagnosed with any other malignant tumor
- Subjects who have experienced severe infections within 28 days prior to their first medication use
- History of immunodeficiency
- Use of attenuated live vaccine within 28 days prior to the first study medication
- Have undergone major surgery within 28 days prior to the first administration of medication
- Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting