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A Randomized, Controlled, Open-label, Global Phase 3 Study Comparing the Efficacy of the Anti-PD-1 Antibody Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Patients With Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma

Description

Brief Summary
The purpose of this study is to evaluate the efficacy and safety of BGB-A317 as second line treatment in patients with advanced unresectable/metastatic ESCC that has progressed during or after first line therapy.


Phase

N/A

Inclusion and Exclusion Criteria

  • Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
  • Tumor progression during or after first-line treatment for advanced unresectable / metastatic ESCC
  • At least one measurable/evaluable lesion by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization
  • Adequate End organ function

  • Receipt of 2 or more prior systemic treatments for advanced/metastatic unresectable ESCC
  • History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization
  • Apparent tumor invasion into organs located adjacent to the esophageal disease site (eg, aorta or respiratory tract) at an increased risk of fistula in the study treatment assessed by investigator
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage
  • Received prior therapies targeting PD-1 or PD-L1
  • Prior malignancy active within the previous 2 years (exceptions include the tumor under investigation in this trial, and locally recurring cancers that have undergone curative treatment, such as resected basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast)
  • Active brain or leptomeningeal metastasis.
  • Has active autoimmune disease or history of autoimmune diseases at high risk for relapse
  • Known history of, or any evidence of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis diagnosed based on imaging or clinical findings, or uncontrolled systemic diseases, including diabetes, hypertension, acute lung diseases, etc
  • Known history of Human Immunodeficiency Virus (HIV)
  • Has cardiovascular risk factors
  • Pregnant or breastfeeding woman. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites

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