Trial · NCT03783442
A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
NCT03783442, Phase 3, Completed, BeiGene; results first posted 2023-11-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma. Trials, record NCT03783442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03783442
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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) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
- NCT number
- NCT03783442
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 649 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Esophageal Squamous Cell Carcinoma (ESCC)
- Interventions
- Cisplatin, Oxaliplatin, Fluorouracil (5-FU), Capecitabine, Paclitaxel, Tislelizumab, Placebo
- First posted
- 2018-12-21
- Last updated
- 2025-07-29
- Other registries' IDs
- eudract:2018-000587-28
- Results first posted
- 2023-11-07
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | Overall survival is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. |
| Secondary | Progression-Free Survival (PFS) | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | Progression-free survival is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, and an absolute increase of at least 5 mm, or unequivocal progression of existing nontarget lesions, or the appearance of 1 or more new lesions. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis. |
| Secondary | Objective Response Rate (ORR) | Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | ORR is defined as the percentage of participants whose best overall response (BOR) was complete response (CR) or partial response (PR) assessed by the investigator per RECIST v1.1. Tumor assessments included computed tomography (CT) scans or magnetic resonance imaging (MRI), with preference for CT, of the neck, chest, and abdomen. CR: Disappearance of all target and nontarget lesions with no new lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm. PR: Disappearance of all target lesions with persistence of 1 or more nontarget lesion(s), no new lesions, and/or maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis (data cutoff date of 28 February 2022). |
| Secondary | Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10% | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | OS is defined as the time from the date of randomization until the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis. |
| Secondary | Duration of Response (DOR) | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method. Primary analysis (data cut-off date of 28 February 2022) was the pre-defined analysis at which the primary endpoint was tested for superiority. Testing for all secondary efficacy endpoints was conducted at the time of the primary analysis. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores | Baseline, Cycle 6 (Week 15) | The EORTC-QLQ-OES18 is the specific esophageal symptoms module of the QLQ-C30. QLQ-OES18 is comprised of 18 questions grouped into 4 multi-item subscales: Dysphagia (3 items), Eating (4 items), Reflux (2 items), and Pain (3 items) and 6 single item subscales (trouble swallowing saliva, choking, dry mouth, taste, coughing, and talking). Participants indicate the extent to which they have experienced symptoms on a scale from 1 (Not at all) to 4 (Very much). Scores are calculated as the average of the items that contribute to the scale, then transformed to a scale from 0 to 100. The OES18 index score is calculated as the average of the 4 multi-item subscales and 6 single-item subscales. Higher scores indicate a higher level of symptomatology or problems. |
| Secondary | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) and Physical Functioning Scales | Baseline, Cycle 6 (Week 15) | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Fatigue Scale | Baseline, Cycle 6 (Week 15) | The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed to a 0 to 100 scale via linear transformation. The fatigue symptom scale includes 3 items and ranges from 0 to 100, where higher scores indicate a higher level of symptoms. |
| Secondary | Change From Baseline in European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) | Baseline, Cycle 6 (Week 15) | The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes. |
| Secondary | Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study drug up to 30 days after last dose; maximum time on treatment was 63.5 months. | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drugs, whether related to study drugs or not. An SAE is any untoward medical occurrence that, at any dose met any of the following criteria: * Resulted in death * Was life-threatening * Required hospitalization or prolongation of existing hospitalization * Resulted in disability/incapacity * Was a congenital anomaly/birth defect * Was considered a significant medical AE by the Investigator based on medical judgement. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | The ITT analysis set included all randomized participants | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | ITT Analysis Set | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | Response was assessed every 6 weeks for the first 48 weeks, then every 9 weeks thereafter; up to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | ITT Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10% | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | ITT Analysis Set participants with PD-L1 score ≥ 10% | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | From randomization to the primary analysis cutoff date of 28 February 2022; maximum time on follow-up was 3 years and 2 months. | Participants in the ITT Analysis Set with an objective response | months | MEDIAN |
| SECONDARY | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Oesophageal Cancer 18 Question Module (QLQ-OES18) Dysphagia, Eating, Reflux, Pain, and Index Scores | Baseline, Cycle 6 (Week 15) | Participants in the ITT Analysis Set who completed the EORTC QLQ-OES18 at Baseline and at least one post-baseline measurement. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) and Physical Functioning Scales | Baseline, Cycle 6 (Week 15) | Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline and at least one post-baseline measurement. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EORTC QLQ-C30 Fatigue Scale | Baseline, Cycle 6 (Week 15) | Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at Baseline and at least one post-baseline measurement. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in European Quality of Life 5-Dimension 5-Level (EQ-5D-5L) Visual Analog Scale (VAS) | Baseline, Cycle 6 (Week 15) | Participants in the ITT Analysis Set with EQ-5D-5L measurement at both Baseline and Cycle 6. | score on a scale | MEAN |
| SECONDARY | Number of Participants Experiencing Treatment-emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | From first dose of study drug up to 30 days after last dose; maximum time on treatment was 63.5 months. | Safety analysis set included all participants who received at least 1 dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Tislelizumab + Chemotherapy | 17.2 | 95% Confidence Interval 15.8 to 20.1 | months | |
| Overall Survival (OS) | Placebo + Chemotherapy | 10.6 | 95% Confidence Interval 9.3 to 12.1 | months | |
| Progression-Free Survival (PFS) | Tislelizumab + Chemotherapy | 7.3 | 95% Confidence Interval 6.9 to 8.3 | months | |
| Progression-Free Survival (PFS) | Placebo + Chemotherapy | 5.6 | 95% Confidence Interval 4.9 to 6.0 | months | |
| Objective Response Rate (ORR) | Tislelizumab + Chemotherapy | 63.5 | 95% Confidence Interval 58.0 to 68.7 | percentage of participants | |
| Objective Response Rate (ORR) | Placebo + Chemotherapy | 42.4 | 95% Confidence Interval 37.0 to 48.0 | percentage of participants | |
| Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10% | Tislelizumab + Chemotherapy | 16.6 | 95% Confidence Interval 15.3 to 24.4 | months | |
| Overall Survival (OS) in Participants With a PD-L1 Score ≥ 10% | Placebo + Chemotherapy | 10.0 | 95% Confidence Interval 8.6 to 13.3 | months | |
| Duration of Response (DOR) | Tislelizumab + Chemotherapy | 7.1 | 95% Confidence Interval 6.1 to 8.1 | months | |
| Duration of Response (DOR) | Placebo + Chemotherapy | 5.7 | 95% Confidence Interval 4.4 to 7.1 | months |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 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 + Chemotherapy | 326 | |
| Overall Study | STARTED | Placebo + Chemotherapy | 323 | |
| Overall Study | Treated | Tislelizumab + Chemotherapy | 324 | |
| Overall Study | Treated | Placebo + Chemotherapy | 321 | |
| Overall Study | COMPLETED | Tislelizumab + Chemotherapy | 0 | |
| Overall Study | COMPLETED | Placebo + Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Tislelizumab + Chemotherapy | 326 | |
| Overall Study | NOT COMPLETED | Placebo + Chemotherapy | 323 |
Source ClinicalTrials.gov
Adverse events548
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 + Chemotherapy | 193 | 324 | 343 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 180 | 321 | 322 |
| other | Coagulopathy | Blood and lymphatic system disorders | Tislelizumab + Chemotherapy | 13 | 324 | 15 |
| other | Coagulopathy | Blood and lymphatic system disorders | Placebo + Chemotherapy | 3 | 321 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Tislelizumab + Chemotherapy | 34 | 324 | 86 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 28 | 321 | 87 |
| other | Neutropenia | Blood and lymphatic system disorders | Tislelizumab + Chemotherapy | 54 | 324 | 122 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 45 | 321 | 148 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tislelizumab + Chemotherapy | 29 | 324 | 43 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 24 | 321 | 36 |
1 to 10 of 548Source ClinicalTrials.gov
See all 548 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tislelizumab + Chemotherapy | 252 | 326 |
| Total, all-cause mortality | Placebo + Chemotherapy | 268 | 323 |
| Total, other adverse events | Tislelizumab + Chemotherapy | 321 | 324 |
| Total, other adverse events | Placebo + Chemotherapy | 314 | 321 |
| Total, serious adverse events | Tislelizumab + Chemotherapy | 160 | 324 |
| Total, serious adverse events | Placebo + Chemotherapy | 128 | 321 |
Source ClinicalTrials.gov
Papers4
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 + Chemotherapy vs Placebo + Chemotherapy: deaths from any cause | Trial comparisons |
| Tislelizumab + Chemotherapy vs Placebo + Chemotherapy: 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.
GET https://conductscience.org/api/trials/v1/NCT03783442
GET https://conductscience.org/api/trials/v1/NCT03783442/results?page=2