Advanced Unresectable/Metastatic Esophageal Squamous Cell Carcinoma(ESCC) MedDRA version: 21.0 Level: LLT Classification code 10055476 Term: Esophageal squamous cell carcinoma System Organ Class: 100000004864
Conditions
Sponsors
BeiGene, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC) 2. Tumor progression during or after first-line systemic treatment for advanced unresectable / metastatic ESCC 3. At least one measurable/evaluable lesion by RECIST v1.1 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 prior to randomization 5. Adequate End organ function Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. Receipt of 2 or more prior lines of systemic treatments for advanced/metastatic unresectable ESCC 2. History of gastrointestinal perforation and /or fistula or aorto-esophageal fistula within 6 months prior to randomization 3. 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 4. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage 5. Received prior therapies targeting PD-1 or PD-L1 6. Prior malignancy active within the previous 2 years before randomisation (exceptions include the tumor under investigation in this study, 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) 7. Active brain or leptomeningeal metastasis. 8. Has active autoimmune disease or history of autoimmune diseases at high risk for relapse 9. 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 10. Known history of Human Immunodeficiency Virus (HIV) 11. Has cardiovascular risk factors 12. Pregnant or breastfeeding woman.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the overall survival (OS) in the Intention-to-Treat (ITT) population following treatment with tislelizumab vs. investigator chosen chemotherapy (ICC) when given as second line treatment in patients with advanced unresectable/metastatic Esophageal Squamous Cell Carcinoma (ESCC) ;Secondary Objective: Key Secondary Objective: •To compare the OS in programmed cell death protein ligand-1 (PD-L1) positive population following treatment with tislelizumab versus investigator chosen chemotherapy (ICC) Other Secondary Objectives: •The following will be compared between tislelizumab and ICC based on assessment by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria: o Progression-free survival (PFS) o Duration of response (DOR) • To compare patient reported outcomes of health-related quality of life (HRQoL) between the tislelizumab and the chemotherapy treatments • To compare the safety and tolerability between tislelizumab and the chemotherapy treatments ;Primary end point(s): • OS in the ITT analysis set- defined as the time from the date of randomization until the date of death due to any cause in all randomized patients ;Timepoint(s) of evaluation of this end point: The final analysis of OS will occur at approximately 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary Endpoint: • OS in the PD-L1 positive analysis set - defined as the time from the date of randomization until the date of death due to any cause in the PDL1 positive population Other Secondary Endpoints: • ORR in both the ITT analysis set and the PD-L1 positive analysis set - defined as the proportion of patients who had complete response (CR) or partial response (PR) assessed by the Investigators per RECIST v1.1 • PFS in both the ITT analysis set and the PD-L1 positive analysis set - defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the Investigators per RECIST v1.1 or death, whichever occurs first • DOR in both the ITT analysis set and the PD-L1 positive analysis set - defined as the time from the first determination of an objective response until the first documentation of progression assessed by the Investigators per RECIST v1.1 or death, whichever comes first • HRQoL assessment • The incidence and severity of adverse events ;Timepoint(s) of evaluation of this end point: ORR as assessed by investigator PFS as assessed by investigator DOR as assessed by investigator HRQoL as assessed by European EORTC QLQ-C30 index, the European esophageal cancer specific module OES18, and the EQ-5D-5L. Incidence and severity of adverse events according to NCI-CTCAE v4.0 | — |
Countries
Belgium, France, Germany, Italy, Japan, Korea, Republic of, Spain, Taiwan, United Kingdom
Contacts
Public ContactBeiGene Clinical Support
BeiGene, Ltd.
Outcome results
None listed