Status:
COMPLETED
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Lead Sponsor:
BeiGene
Conditions:
Esophageal Squamous Cell Carcinoma (ESCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of tislelizumab as first line treatment in combination with chemotherapy in participants with advanced unresectable/metastatic esophage...
Eligibility Criteria
Inclusion
- Key
- Pathologically (histologically) confirmed diagnosis of ESCC
- Stage IV unresectable ESCC at first diagnosis OR unresectable, locally advanced recurrent or metastatic disease (per American Joint Committee on Cancer 7th Edition), if there is prior neoadjuvant/adjuvant therapy with platinum-based chemotherapy, a treatment-free interval of at least 6 months is required.
- Key
Exclusion
- Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
- Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
- Received prior therapies targeting programmed cell death protein-1 (PD-1), programmed cell death protein ligand-1 (PD-L1) or PD-L2
- Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta)
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (clinically significant recurrence requiring an additional intervention within 2 weeks of intervention)
- Evidence of complete esophageal obstruction not amenable to treatment
- Unintentional weight loss ≥ 5% within one month prior to randomization or Nutritional Risk Index (NRI) \< 83.5 per investigator's choice
- Locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy per local investigator.
- Participants with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is ≥ 500 IU/mL or participants with active hepatitis C virus (HCV)
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
December 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2024
Estimated Enrollment :
649 Patients enrolled
Trial Details
Trial ID
NCT03783442
Start Date
December 11 2018
End Date
August 22 2024
Last Update
July 29 2025
Active Locations (124)
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1
Smilow Cancer Hospital At Yale
New Haven, Connecticut, United States, 06510-3220
2
Renovatio Clinical
The Woodlands, Texas, United States, 77380-3476
3
Coffs Harbour Base Hospital
Coffs Harbour, New South Wales, Australia, 2450
4
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, 3065