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Recruiting NCT06879145

Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)

Phase II / Phase III Interventional Muscular Invasive Bladder Cancer (MIBC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SHR-A2102；Adebrelimab.
Who it may be relevant to
Registry conditions: Muscular Invasive Bladder Cancer (MIBC). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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

  • Drug SHR-A2102；Adebrelimab
    Treatment with SHR-A2102 in combination with fixed dose Adebrelimab

Primary outcome measures

  • Phase II: pCR evaluated by researchers; [Time frame: Three months after the last subject underwent RC+PLD surgery]
  • Phase III: EFS assessed by BICR； [Time frame: 5 years after the first medication of the last subject]
Secondary outcome measures (8)
  • ORR [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
  • DCR [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
  • pCR [Time frame: Three months after MIBC surgery]
  • EFS [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
  • DFS [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
  • OS [Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years]
  • R0 resection rate [Time frame: One month after the last subject underwent RC+PLD surgery]
  • AE [Time frame: from Day1 to 90 days after last dose]

Eligibility criteria

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06879145 · SHR-A2102-303

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗