NCT06879145RecruitingPhase 2/3
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
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 · Last updated 13 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 840 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- 25 Apr 2025
- Primary completion date
- Dec 2031
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Bladder cancer
- NCT number
- NCT06879145
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 840
- From 25 Apr 2025 to the primary completion date, Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who have experienced severe infections within 28 days prior to their first medication use
- 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
Other illness
- 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
- History of immunodeficiency
Other
- Subjects known or suspected to have interstitial pneumonia
Who the study is looking for
- \- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.