Clinical Trials List
Protocol NumberBGB-A317-306
Completed
2019-06-01 - 2024-09-30
Phase III
Recruiting1
Terminated4
A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy and safety of tislelizumab (BGB-A317) in combination with chemotherapy as first-line treatment in patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
BeiGene, Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Yu-Li Su Division of Hematology & Oncology
- 林偉哲 Division of Hematology & Oncology
- Tai-Jan Chiu Division of Hematology & Oncology
- 吳佳哲 Division of Hematology & Oncology
- 黃泰霖 Division of Hematology & Oncology
- 劉建廷 Division of Hematology & Oncology
- 陳彥豪 Division of Hematology & Oncology
- 湯禹舜 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 陳昭勳 Division of Hematology & Oncology
- 陳彥勳 Division of Hematology & Oncology
- 曹朝榮 Division of Hematology & Oncology
- 林正耀 Division of Hematology & Oncology
- Shang-Wen Chen Division of Hematology & Oncology
- 高婉真 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
- 蕭聖諺 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Completed
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Chi-Ching Chen Division of Hematology & Oncology
- Ming-Yu Lien Division of Hematology & Oncology
- Chang-Fang Chiu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
5 Stop recruiting
Condition/Disease
unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma
Objectives
Primary:
To evaluate and compare the progression-free survival (PFS) assessed by blinded independent
review committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version
(v) 1.1 following treatment with tislelizumab in combination with chemotherapy compared to
placebo in combination with chemotherapy when given as first-line treatment in patients with
unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma
(ESCC)
To evaluate and compare the overall survival (OS) following treatment with tislelizumab in
combination with chemotherapy compared to placebo in combination with chemotherapy when
given as first-line treatment in patients with unresectable, locally advanced recurrent or
metastatic ESCC
Secondary:
To evaluate and compare the efficacy of tislelizumab in combination with chemotherapy
compared to placebo in combination with chemotherapy as a first-line treatment in
unresectable, locally advanced recurrent or metastatic ESCC as measured by objective
response rate (ORR) and duration of response (DOR) assessed by BIRC per RECIST v1.1
To evaluate and compare Patient Reported Outcomes (PROs) of health-related quality of life
(HRQoL) between tislelizumab in combination with chemotherapy compared to placebo in
combination with chemotherapy
To evaluate and compare the efficacy of tislelizumab in combination with chemotherapy
compared to placebo in combination with chemotherapy as a first-line treatment in
unresectable, locally advanced recurrent or metastatic ESCC as measured by PFS, ORR, and
DOR assessed by the treating investigator per RECIST v1.1
To compare the safety between tislelizumab in combination with chemotherapy and placebo in
combination with chemotherapy
Test Drug
BGB-A317
Active Ingredient
BGB-A317(Tislelizumab)
Dosage Form
injection
Dosage
10 mg/mL
Endpoints
Primary:
PFS - defined as the time from the date of randomization to the date of first documentation of
disease progression assessed by BIRC per RECIST v1.1 or death, whichever occurs first
OS - defined as the time from the date of randomization until the date of death due to any cause
Secondary:
ORR - defined as the proportion of patients whose best overall response (BOR) is complete
response (CR) or partial response (PR) assessed by BIRC per RECIST v1.1
DOR- defined as the time from the first determination of an objective response until the first
documentation of progression assessed by BIRC per RECIST v1.1 or death, whichever comes
first
HRQoL assessment of the patient’s overall health status using European EORTC QLQ-C30
index, the European esophageal cancer specific module EORTC QLQ-OES18, and the generic
health state instrument EuroQol 5D (EQ-5D-5L)
PFS, ORR, and DOR assessed by the investigator per RECIST v1.1
The incidence and severity of adverse events (AEs) according to National Cancer Institute
Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03
PFS - defined as the time from the date of randomization to the date of first documentation of
disease progression assessed by BIRC per RECIST v1.1 or death, whichever occurs first
OS - defined as the time from the date of randomization until the date of death due to any cause
Secondary:
ORR - defined as the proportion of patients whose best overall response (BOR) is complete
response (CR) or partial response (PR) assessed by BIRC per RECIST v1.1
DOR- defined as the time from the first determination of an objective response until the first
documentation of progression assessed by BIRC per RECIST v1.1 or death, whichever comes
first
HRQoL assessment of the patient’s overall health status using European EORTC QLQ-C30
index, the European esophageal cancer specific module EORTC QLQ-OES18, and the generic
health state instrument EuroQol 5D (EQ-5D-5L)
PFS, ORR, and DOR assessed by the investigator per RECIST v1.1
The incidence and severity of adverse events (AEs) according to National Cancer Institute
Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.03
Inclution Criteria
-Pathologically (histologically) confirmed diagnosis of ESCC
-Stage IV, per AJCC 7th Edition (Edge et al 2010), unresectable ESCC at first diagnosis
OR unresectable, locally advanced recurrent or metastatic disease with at least a
6-month treatment-free interval if definitive treatment was given.
-Stage IV, per AJCC 7th Edition (Edge et al 2010), unresectable ESCC at first diagnosis
OR unresectable, locally advanced recurrent or metastatic disease with at least a
6-month treatment-free interval if definitive treatment was given.
Exclusion Criteria
-Palliative radiation treatment for ESCC within 4 weeks of study treatment initiation
-Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
-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
-Received prior therapies targeting PD-1, PD-L1 or PD-L2
-Unintentional weight loss ≥ 5% within 1 month prior to randomization or other
indicators of severe malnutrition (severe malnutrition may be determined using the
Nutritional Risk Index (Shirasu et al 2018)
-Prior systemic therapy for unresectable, locally advanced recurrent or metastatic ESCC
-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
-Received prior therapies targeting PD-1, PD-L1 or PD-L2
-Unintentional weight loss ≥ 5% within 1 month prior to randomization or other
indicators of severe malnutrition (severe malnutrition may be determined using the
Nutritional Risk Index (Shirasu et al 2018)
The Estimated Number of Participants
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Taiwan
24 participants
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Global
746 participants
