Trial · NCT03430843
A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
NCT03430843, Phase 3, Completed, BeiGene; results first posted 2023-12-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma. Trials, record NCT03430843. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03430843
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
- NCT number
- NCT03430843
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 512 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Interventions
- Tislelizumab, Paclitaxel, Docetaxel, Irinotecan
- First posted
- 2018-02-13
- Last updated
- 2024-10-26
- Other registries' IDs
- eudract:2017-003699-30
- Results first posted
- 2023-12-29
- Limitations and caveats
The impact on treatment was considered very limited due to the small number of patients remaining on treatment, the short COVID-19 restriction period (in Asia), and limited restrictions for healthcare visits (in Europe/North America).
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set | Approximately 2 years and 10 months from date of first randomization | OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants |
| Secondary | Overall Survival (OS) in the PDL-1 Positive Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%. |
| Secondary | Objective Response Rate (ORR) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; |
| Secondary | Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1; |
| Secondary | Progression-free Survival (PFS) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set |
| Secondary | Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set |
| Secondary | Duration of Response (DOR) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first |
| Secondary | Duration of Response (DOR) in the PDL-1 Positive Analysis Set. | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first |
| Secondary | Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes |
| Secondary | HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set | Baseline to Cycle 6 (21 days per cycle) | Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set | Approximately 2 years and 10 months from date of first randomization | The ITT analysis set included all randomized participants | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in the PDL-1 Positive Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The PD-L1 positive population included all randomized participants with tumor PD-L1 vCPS ≥10% | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The ITT analysis set included all randomized participants | Percentage of Participants | NUMBER |
| SECONDARY | Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10% | Percentage of Participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The ITT analysis set included all randomized participants | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10% | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) in the ITT Analysis Set | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis | Months | MEDIAN |
| SECONDARY | Duration of Response (DOR) in the PDL-1 Positive Analysis Set. | Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years) | The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; only participants with an objective response (CR or PR) were included in this analysis | Months | MEDIAN |
| SECONDARY | Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set | Baseline to Cycle 6 (21 days per cycle) | The ITT analysis set included all randomized participants; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point. | Score on a scale | MEAN |
| SECONDARY | HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set | Baseline to Cycle 6 (21 days per cycle) | The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; Overall number of participants analyzed refers to number of participants evaluable for this outcome measure and Number analyzed refers to participants evaluable at the specified time point. | Score on a scale | MEAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set | Tislelizumab | 8.6 | 95% Confidence Interval 7.5 to 10.4 | Months | |
| Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set | Investigator Chosen Chemotherapy | 6.3 | 95% Confidence Interval 5.3 to 7.0 | Months | |
| Overall Survival (OS) in the PDL-1 Positive Analysis Set | Tislelizumab | 10.2 | 95% Confidence Interval 8.5 to 14.5 | Months | |
| Overall Survival (OS) in the PDL-1 Positive Analysis Set | Investigator Chosen Chemotherapy | 5.1 | 95% Confidence Interval 3.8 to 8.2 | Months | |
| Objective Response Rate (ORR) in the ITT Analysis Set | Tislelizumab | 20.3 | 95% Confidence Interval 15.6 to 25.8 | Percentage of Participants | |
| Objective Response Rate (ORR) in the ITT Analysis Set | Investigator Chosen Chemotherapy | 9.8 | 95% Confidence Interval 6.4 to 14.1 | Percentage of Participants | |
| Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets | Tislelizumab | 26.3 | 95% Confidence Interval 17 to 37.3 | Percentage of Participants | |
| Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets | Investigator Chosen Chemotherapy | 11.3 | 95% Confidence Interval 4.7 to 21.9 | Percentage of Participants | |
| Progression-free Survival (PFS) in the ITT Analysis Set | Tislelizumab | 1.6 | 95% Confidence Interval 1.4 to 2.7 | Months | |
| Progression-free Survival (PFS) in the ITT Analysis Set | Investigator Chosen Chemotherapy | 2.1 | 95% Confidence Interval 1.5 to 2.7 | Months |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tislelizumab | 256 | |
| Overall Study | STARTED | Investigator Chosen Chemotherapy | 256 | |
| Overall Study | Treated | Tislelizumab | 255 | |
| Overall Study | Treated | Investigator Chosen Chemotherapy | 240 | |
| Overall Study | COMPLETED | Tislelizumab | 0 | |
| Overall Study | COMPLETED | Investigator Chosen Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Tislelizumab | 256 | |
| Overall Study | NOT COMPLETED | Investigator Chosen Chemotherapy | 256 |
Source ClinicalTrials.gov
Adverse events408
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Tislelizumab | 80 | 255 | 139 |
| other | Anaemia | Blood and lymphatic system disorders | Investigator Chosen Chemotherapy (ICC) | 109 | 240 | 192 |
| other | Leukopenia | Blood and lymphatic system disorders | Tislelizumab | 9 | 255 | 19 |
| other | Leukopenia | Blood and lymphatic system disorders | Investigator Chosen Chemotherapy (ICC) | 29 | 240 | 57 |
| other | Neutropenia | Blood and lymphatic system disorders | Tislelizumab | 2 | 255 | 11 |
| other | Neutropenia | Blood and lymphatic system disorders | Investigator Chosen Chemotherapy (ICC) | 30 | 240 | 56 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tislelizumab | 5 | 255 | 7 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Investigator Chosen Chemotherapy (ICC) | 10 | 240 | 13 |
| other | Hyperthyroidism | Endocrine disorders | Tislelizumab | 8 | 255 | 8 |
| other | Hyperthyroidism | Endocrine disorders | Investigator Chosen Chemotherapy (ICC) | 1 | 240 | 1 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tislelizumab | 233 | 256 |
| Total, all-cause mortality | Investigator Chosen Chemotherapy (ICC) | 233 | 256 |
| Total, other adverse events | Tislelizumab | 232 | 255 |
| Total, other adverse events | Investigator Chosen Chemotherapy (ICC) | 231 | 240 |
| Total, serious adverse events | Tislelizumab | 109 | 255 |
| Total, serious adverse events | Investigator Chosen Chemotherapy (ICC) | 106 | 240 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tislelizumab vs Investigator Chosen Chemotherapy (ICC): deaths from any cause | Trial comparisons |
| Tislelizumab vs Investigator Chosen Chemotherapy (ICC): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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