Status:
COMPLETED
A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second 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 was to evaluate the efficacy and safety of tislelizumab as second line treatment in participants with advanced unresectable/metastatic ESCC that had progressed during or afte...
Eligibility Criteria
Inclusion
- Key
- 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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization
- Key
Exclusion
- 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
- 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 programmed death 1 (PD-1) or programmed death ligand 1 (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.
Key Trial Info
Start Date :
January 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 28 2022
Estimated Enrollment :
512 Patients enrolled
Trial Details
Trial ID
NCT03430843
Start Date
January 26 2018
End Date
December 28 2022
Last Update
October 26 2024
Active Locations (104)
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1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
2
Toledo Clinic Cancer Center
Toledo, Ohio, United States, 43623
3
Imelda Ziekenhuis Bonheiden
Bonheiden, Belgium, 2820
4
Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200