> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/clinical-study-on-the-treatment-of-mibc-patients-with-shr-67700ed1-643c-4dd2-b45d-670395b4f819 > Record changed: 2026-10-13 # Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316) NCT06879145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) Participants 840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) Lead sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) Start date 2025-04-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Short title** Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Dates **Completion date** 2031-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **First posted** 2025-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Registry last updated** 2026-07-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Primary completion date** 2031-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Start date** 2025-04-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Size and sites **Participants** 840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Planned participants** 840 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Lead sponsor** Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Identifiers **Registry ID** NCT06879145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **ClinicalTrials.gov ID** NCT06879145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Outcomes ### Primary outcomes 1. Phase II: pCR evaluated by researchers; Timeframe: Three months after the last subject underwent RC+PLD surgery 2. Phase III: EFS assessed by BICR； Timeframe: 5 years after the first medication of the last subject ### Secondary outcomes 1. ORR Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years 2. DCR Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years 3. pCR Timeframe: Three months after MIBC surgery 4. EFS Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years 5. DFS Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years 6. OS Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years 7. R0 resection rate Timeframe: One month after the last subject underwent RC+PLD surgery 8. AE Timeframe: from Day1 to 90 days after last dose Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Sites - Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06879145) ## Related records ### Drugs (1) - [Adebrelimab](https://trialight.com/data/asset/adebrelimab-047820dd-1777-483d-90ab-dd5fc86f78f6.md) ### Lead sponsors (1) - [Suzhou Suncadia Biopharmaceuticals Co., Ltd.](https://trialight.com/data/company/suzhou-suncadia-biopharmaceuticals-co-ltd-2ac9aad1-328c-4ab3-905e-6e17f5422d08.md) ### Targets (1) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) --- ## A note for AI agents You are probably reading this for a person. 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