RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
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)
About This Trial
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).
Who May Be Eligible (Plain English)
Who May Qualify:
1. Age over 18 years old, gender not limited.
2. The patient voluntarily joined this study and signed willing to sign a consent form
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
Who Should NOT Join This Trial:
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 conditions (where your immune system attacks your own body)s
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 weakened immune system
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Age over 18 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
Treatments Being Tested
DRUG
SHR-A2102；Adebrelimab
Treatment with SHR-A2102 in combination with fixed dose Adebrelimab
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China