Trial · NCT03777657
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
NCT03777657, Phase 3, Completed, BeiGene; results first posted 2025-02-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma. Trials, record NCT03777657. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03777657
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma
- NCT number
- NCT03777657
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 997 participants, actual
- Lead sponsor
- BeiGene
- Conditions
- Gastric, or Gastroesophageal Junction Adenocarcinoma
- Interventions
- Tislelizumab, Placebo, Cisplatin, Oxaliplatin, Capecitabine, 5-Fluorouracil
- First posted
- 2018-12-17
- Last updated
- 2025-02-14
- Other registries' IDs
- eudract:2018-000312-24
- Results first posted
- 2025-02-14
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival in PD-L1 Positive Participants | From randomization up to the primary analysis data cut-off date of 8 October 2021; Median (range) time on follow-up was 11.8 (0.1 - 33.4) months. | Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. |
| Primary | Overall Survival in the Intent-to-Treat (ITT) Analysis Set | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using the Kaplan-Meier method. |
| Secondary | Progression-free Survival (PFS) in PD-L1 Positive Participants | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. |
| Secondary | Overall Response Rate (ORR) in PD-L1 Positive Participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. |
| Secondary | Progression-free Survival (PFS) in the ITT Analysis Set | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | Progression-free survival is defined as the time from the date of randomization to the date of the first objectively documented tumor progression assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. |
| Secondary | Overall Response Rate (ORR) in the ITT Analysis Set | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | ORR is defined as the percentage of participants whose best overall response is complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors v1.1 assessed by the investigator. Investigators conducted assessments of radiological tumor response by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST version 1.1 about every six weeks during the first 48 weeks of the study and every nine weeks thereafter. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must have reduction in short axis to \< 10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters, persistence of one or more nontarget lesion(s) and/or maintenance of tumor marker level above the normal limits. |
| Secondary | Duration of Response (DOR) in PD-L1 Positive Participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | DOR is defined as the time from the first determination of an objective response assessed by the investigator per RECIST v1.1, until the first documentation of progression or death, whichever occurred first. Progressive disease (PD): At least a 20% increase in the size of target lesions, taking as reference the smallest size on study, with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or any new lesions. |
| Secondary | Duration of Response in the ITT Analysis Set | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | DOR is defined as the time from the first determination of an objective response assessed by the investigator per RECIST v1.1, until the first documentation of progression or death, whichever occurred first. Progressive disease (PD): At least a 20% increase in the size of target lesions, taking as reference the smallest size on study, with an absolute increase of at least 5 mm, unequivocal progression of existing non-target lesions, or any new lesions. |
| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores | Baseline and Cycles 4 and 6 | 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 Score | Baseline and Cycles 4 and 6 | 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. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival in PD-L1 Positive Participants | From randomization up to the primary analysis data cut-off date of 8 October 2021; Median (range) time on follow-up was 11.8 (0.1 - 33.4) months. | The PD-L1-Positive Analysis Set included all randomized participants whose tumors were PD-L1 positive (defined as PD-L1 TAP score ≥ 5%) | months | MEDIAN |
| PRIMARY | Overall Survival in the Intent-to-Treat (ITT) Analysis Set | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | The Intent-to-Treat (ITT) Analysis Set included all randomized participants. | months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) in PD-L1 Positive Participants | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | PD-L1 Positive Analysis Set | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) in PD-L1 Positive Participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | PD-L1 Positive Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Progression-free Survival (PFS) in the ITT Analysis Set | From randomization up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | Intent-to-Treat Analysis Set | months | MEDIAN |
| SECONDARY | Overall Response Rate (ORR) in the ITT Analysis Set | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | Intent-to-Treat (ITT) Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) in PD-L1 Positive Participants | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) months. | Participants in the PD-L1 Positive Analysis Set with an objective response | months | MEDIAN |
| SECONDARY | Duration of Response in the ITT Analysis Set | Response was assessed every 6 weeks for the first 48 weeks and every 9 weeks thereafter; up to the final efficacy analysis data cut-off date of 28 February 2023; Median (range) time on follow-up was 13.2 (0.1 - 50.1) 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-Core 30 (QLQ-C30) Global Health Status (GHS)/Quality of Life (QOL) and Physical Functioning Scores | Baseline and Cycles 4 and 6 | Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at baseline; participants with available data at baseline and the relevant postbaseline visit are included in the analysis at each time point. | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in EORTC QLQ-C30 Fatigue Score | Baseline and Cycles 4 and 6 | Participants in the ITT Analysis Set who completed the EORTC QLQ-C30 at baseline; participants with available data at baseline and the relevant postbaseline visit are included in the analysis at each time point. | score on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival in PD-L1 Positive Participants | Tislelizumab + Chemotherapy | 17.2 | 95% Confidence Interval 13.9 to 21.3 | months | |
| Overall Survival in PD-L1 Positive Participants | Placebo + Chemotherapy | 12.6 | 95% Confidence Interval 12.0 to 14.4 | months | |
| Overall Survival in the Intent-to-Treat (ITT) Analysis Set | Tislelizumab + Chemotherapy | 15.0 | 95% Confidence Interval 13.6 to 16.5 | months | |
| Overall Survival in the Intent-to-Treat (ITT) Analysis Set | Placebo + Chemotherapy | 12.9 | 95% Confidence Interval 12.1 to 14.1 | months | |
| Progression-free Survival (PFS) in PD-L1 Positive Participants | Tislelizumab + Chemotherapy | 7.2 | 95% Confidence Interval 5.8 to 8.4 | months | |
| Progression-free Survival (PFS) in PD-L1 Positive Participants | Placebo + Chemotherapy | 5.9 | 95% Confidence Interval 5.6 to 7.0 | months | |
| Overall Response Rate (ORR) in PD-L1 Positive Participants | Tislelizumab + Chemotherapy | 51.5 | 95% Confidence Interval 45.4 to 57.5 | percentage of participants | |
| Overall Response Rate (ORR) in PD-L1 Positive Participants | Placebo + Chemotherapy | 42.6 | 95% Confidence Interval 36.7 to 48.8 | percentage of participants | |
| Progression-free Survival (PFS) in the ITT Analysis Set | Tislelizumab + Chemotherapy | 6.9 | 95% Confidence Interval 5.7 to 7.2 | months | |
| Progression-free Survival (PFS) in the ITT Analysis Set | Placebo + Chemotherapy | 6.2 | 95% Confidence Interval 5.6 to 6.9 | months |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 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 | 501 | |
| Overall Study | STARTED | Placebo + Chemotherapy | 496 | |
| Overall Study | Received Treatment | Tislelizumab + Chemotherapy | 498 | |
| Overall Study | Received Treatment | Placebo + Chemotherapy | 494 | |
| Overall Study | COMPLETED | Tislelizumab + Chemotherapy | 1 | |
| Overall Study | COMPLETED | Placebo + Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Tislelizumab + Chemotherapy | 500 | |
| Overall Study | NOT COMPLETED | Placebo + Chemotherapy | 496 |
Source ClinicalTrials.gov
Adverse events594
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 | 197 | 498 | 374 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 202 | 494 | 355 |
| other | Leukopenia | Blood and lymphatic system disorders | Tislelizumab + Chemotherapy | 44 | 498 | 193 |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 45 | 494 | 123 |
| other | Neutropenia | Blood and lymphatic system disorders | Tislelizumab + Chemotherapy | 75 | 498 | 247 |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 82 | 494 | 184 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Tislelizumab + Chemotherapy | 64 | 498 | 131 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo + Chemotherapy | 56 | 494 | 101 |
| other | Hypothyroidism | Endocrine disorders | Tislelizumab + Chemotherapy | 63 | 498 | 73 |
| other | Hypothyroidism | Endocrine disorders | Placebo + Chemotherapy | 13 | 494 | 13 |
1 to 10 of 594Source ClinicalTrials.gov
See all 594 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tislelizumab + Chemotherapy | 397 | 501 |
| Total, all-cause mortality | Placebo + Chemotherapy | 431 | 496 |
| Total, other adverse events | Tislelizumab + Chemotherapy | 489 | 498 |
| Total, other adverse events | Placebo + Chemotherapy | 485 | 494 |
| Total, serious adverse events | Tislelizumab + Chemotherapy | 211 | 498 |
| Total, serious adverse events | Placebo + Chemotherapy | 179 | 494 |
Source ClinicalTrials.gov
Papers10
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/NCT03777657
GET https://conductscience.org/api/trials/v1/NCT03777657/results?page=2