NCT03777657 · OUTCOME
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
Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma · Source last updated 2025-02-14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- LEAST_SQUARES_MEAN
- Unit
- score on a scale
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Baseline and Cycles 4 and 6
What was measured
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.
Analysis population: 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.
Groups in this outcome
Tislelizumab + Chemotherapy
Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
Placebo + Chemotherapy
Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Tislelizumab + Chemotherapy | 465 |
|---|
| Placebo + Chemotherapy | 467 |
|---|
Reported measurements
Global Health Status/QOL: Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Tislelizumab + Chemotherapy | 388 |
|---|
| Placebo + Chemotherapy | 380 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tislelizumab + Chemotherapy | 1.35 | Not reported | -0.24 | 2.94 | Not reported |
|---|
| Placebo + Chemotherapy | -0.45 | Not reported | -2.04 | 1.13 | Not reported |
|---|
Global Health Status/QOL: Cycle 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Tislelizumab + Chemotherapy | 359 |
|---|
| Placebo + Chemotherapy | 339 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tislelizumab + Chemotherapy | 0.93 | Not reported | -0.71 | 2.57 | Not reported |
|---|
| Placebo + Chemotherapy | -1.58 | Not reported | -3.24 | 0.07 | Not reported |
|---|
Physical Functioning: Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Tislelizumab + Chemotherapy | 388 |
|---|
| Placebo + Chemotherapy | 380 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tislelizumab + Chemotherapy | -2.47 | Not reported | -3.77 | -1.18 | Not reported |
|---|
| Placebo + Chemotherapy | -3.92 | Not reported | -5.21 | -2.62 | Not reported |
|---|
Physical Functioning: Cycle 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Tislelizumab + Chemotherapy | 359 |
|---|
| Placebo + Chemotherapy | 339 |
|---|
Values in score on a scale · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Tislelizumab + Chemotherapy | -2.76 | Not reported | -4.22 | -1.30 | Not reported |
|---|
| Placebo + Chemotherapy | -5.22 | Not reported | -6.69 | -3.75 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- -0.33
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.94
- estimate Comment
- Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
- group Description
- Analysis of Change from Baseline in Global Health Status/QoL at Cycle 4
- non Inferiority Type
- OTHER
- param Type
- Least Squares (LS) Mean Difference
- param Value
- 1.80
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.74
- estimate Comment
- Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
- group Description
- Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 2.52
- ci Lower Limit
- -0.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.16
- group Description
- Analysis of Change from Baseline in Physical Functioning at Cycle 4
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 1.44
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.43
- estimate Comment
- Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
- group Description
- Analysis of Change from Baseline in Physical Functioning at Cycle 6
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 2.46
Complete source fields
- analyses
- ci Lower Limit
- -0.33
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.94
- estimate Comment
- Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
- group Description
- Analysis of Change from Baseline in Global Health Status/QoL at Cycle 4
- non Inferiority Type
- OTHER
- param Type
- Least Squares (LS) Mean Difference
- param Value
- 1.80
- ci Lower Limit
- 0.29
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.74
- estimate Comment
- Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
- group Description
- Analysis of Change from Baseline in Global Health Status/QoL at Cycle 6
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 2.52
- ci Lower Limit
- -0.27
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.16
- group Description
- Analysis of Change from Baseline in Physical Functioning at Cycle 4
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 1.44
- ci Lower Limit
- 0.49
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 4.43
- estimate Comment
- Mixed effect model analysis with QLQ-C30 scores from cycle 1 to 6 as the response variable, and treatment by study visit interaction, baseline mean score and randomization stratification factors as covariates.
- group Description
- Analysis of Change from Baseline in Physical Functioning at Cycle 6
- non Inferiority Type
- OTHER
- param Type
- LS Mean Difference
- param Value
- 2.46
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.24
- upper Limit
- 2.94
- value
- 1.35
- group Id
- OG001
- lower Limit
- -2.04
- upper Limit
- 1.13
- value
- -0.45
- denoms
- counts
- group Id
- OG000
- value
- 388
- group Id
- OG001
- value
- 380
- units
- Participants
- title
- Global Health Status/QOL: Cycle 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- -0.71
- upper Limit
- 2.57
- value
- 0.93
- group Id
- OG001
- lower Limit
- -3.24
- upper Limit
- 0.07
- value
- -1.58
- denoms
- counts
- group Id
- OG000
- value
- 359
- group Id
- OG001
- value
- 339
- units
- Participants
- title
- Global Health Status/QOL: Cycle 6
- categories
- measurements
- group Id
- OG000
- lower Limit
- -3.77
- upper Limit
- -1.18
- value
- -2.47
- group Id
- OG001
- lower Limit
- -5.21
- upper Limit
- -2.62
- value
- -3.92
- denoms
- counts
- group Id
- OG000
- value
- 388
- group Id
- OG001
- value
- 380
- units
- Participants
- title
- Physical Functioning: Cycle 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- -4.22
- upper Limit
- -1.30
- value
- -2.76
- group Id
- OG001
- lower Limit
- -6.69
- upper Limit
- -3.75
- value
- -5.22
- denoms
- counts
- group Id
- OG000
- value
- 359
- group Id
- OG001
- value
- 339
- units
- Participants
- title
- Physical Functioning: Cycle 6
- denoms
- counts
- group Id
- OG000
- value
- 465
- group Id
- OG001
- value
- 467
- units
- Participants
- description
- 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.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 200 mg of tislelizumab intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with 200 mg tislelizumab, with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
- id
- OG000
- title
- Tislelizumab + Chemotherapy
- description
- Participants received placebo intravenously with investigator's choice of chemotherapy once every 3 weeks for up to six treatment cycles. Thereafter, participants continued treatment with placebo with optional maintenance capecitabine (only permitted for participants who initially received capecitabine and oxaliplatin) once every 3 weeks until disease progression or unacceptable toxicity.
- id
- OG001
- title
- Placebo + Chemotherapy
- param Type
- LEAST_SQUARES_MEAN
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- Baseline and Cycles 4 and 6
- title
- 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
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle