Clinical Trials List
2020-09-16 - 2024-01-31
Phase II
Recruiting6
ICD-10C15.9
Malignant neoplasm of esophagus, unspecified
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9150.9
Malignant neoplasm of esophagus, unspecified
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Compare the Efficacy of Anti-PD-1 Monoclonal Antibody Tislelizumab (BGB-A317) Plus Anti-TIGIT Monoclonal Antibody BGB-A1217 Versus Tislelizumab Plus Placebo as Second-Line Treatment in Patients With PD-L1 vCPS ≥ 10% Unresectable, Locally Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
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Trial Applicant
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Sponsor
BeiGene
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- JHE-CYUAN GUO Division of Hematology & Oncology
- Chia-Chi Lin Division of Hematology & Oncology
- TA-CHEN HUANG Division of Hematology & Oncology
- Kun-Huei Yeh Division of Hematology & Oncology
- 郭弘揚 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
BGB-A317 (Tislelizumab)
Dosage Form
Concentrate for solution for infusion
Dosage
20 mg/ml
Endpoints
Objective Response Rate (ORR) Assessed By The Investigator's Review Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 [ Time Frame: Approximately 17 months ]
The objective response rate will be defined as the proportion of participants who have complete response or partial response.
Overall Survival [ Time Frame: Approximately 32 months ]
Overall survival will be defined as the time from the date of randomization until the date of death due to any cause in all randomized participants.
Inclution Criteria
Histologically confirmed diagnosis of (esophageal squamous cell carcinoma) ESCC.
Have PD during or after first-line of systemic treatment for unresectable, locally advanced, recurrent or metastatic ESCC.
Have measurable disease as assessed by RECIST v1.1.
Have confirmed PD-L1 vCPS ≥ 10% in tumor tissues tested by the central lab.
Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
Exclusion Criteria
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
Participants with evidence of fistula (either esophageal/bronchial or esophageal/aorta).
Evidence of complete esophageal obstruction not amenable to treatment.
Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence within 2 weeks after intervention).
Has received any chemotherapy, immunotherapy (eg, interleukin, interferon, thymosin, etc) or any investigational therapies within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug. Or has received palliative radiation treatment or other local regional therapies within 14 days before the first dose of study drug.
The Estimated Number of Participants
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Taiwan
27 participants
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Global
373 participants
