This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Clinical Trial to Assess the Efficacy and Safety of 'Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea (NCT00807027), a randomized phase 3 study. The primary outcome is Progression-free Survival(PFS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00807027 |
| Phase | Phase 3 |
| Condition | Glioblastoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 180 |
| Arms in the primary outcome | 2 |
| Lead sponsor | GC Cell Corporation |
| Results posted | Yes |
2. Clinical Question
Population
People with newly diagnosed glioblastoma. The registry record describes progression-free survival from randomization and describes treatment after surgery.
Intervention
Activated T lymphocyte therapy, identified as Immuncell-LC, in addition to temozolomide chemotherapy and radiation therapy.
Comparator
Temozolomide chemotherapy and radiation therapy, followed by temozolomide alone, without Immuncell-LC.
Primary question
How did median progression-free survival compare between the group assigned Immuncell-LC with temozolomide-based treatment and the group assigned temozolomide-based treatment alone?
The registry describes a randomized, open-label, parallel-group phase 3 trial. Its stated purpose was to assess efficacy and safety, with progression-free survival as the primary outcome and overall survival listed as a secondary outcome. The posted primary results are group-specific medians with 95% confidence intervals. They describe the observed time-to-event outcome in each group; they are not, by themselves, an adjusted comparison or a test of whether the groups differ statistically.
The registry reports 180 enrolled participants. The posted progression-free survival results include 89 participants in the control group and 91 in the CIK Immunotherapy Group. The registry record does not report a hazard ratio, a confidence interval for a between-group contrast, or a p-value for the primary outcome. Those omissions limit how directly the posted medians can answer a comparative question.
3. Trial Design
This was a multicenter, randomized, open-label phase 3 trial with a parallel-group design. The registry lists 180 enrolled participants and identifies glioblastoma as the condition. The title describes the study as involving newly diagnosed glioblastoma in Korea. The record lists no masking, so participants and study personnel were not masked to assigned treatment according to the registry description.
The control group received temozolomide chemotherapy and radiation therapy for 6 weeks, followed by temozolomide alone for 6 weeks. The test group received Immuncell-LC in addition to temozolomide chemotherapy and radiation therapy described as the same as the control group. Its description states that blood was drawn before manufacture of the test drug. Further details of Immuncell-LC administration, including a complete schedule, are not reported in the registry record.
The posted primary outcome is progression-free survival, measured in months from randomization until the first documented progression or death from any cause, whichever came first. The specified assessment period was up to 46 months. The registry says local investigators assessed progression using enhanced MRI, with assessments after chemoradiotherapy, at specified follow-up times, and during later follow-up. Overall survival is listed as a secondary outcome, but an overall-survival result is not reported in the registry record.
The trial is marked completed. Its listed start date is 2008-12-05, and primary completion is recorded as 2012-10. The registry record does not describe the randomization procedure, allocation ratio, eligibility criteria beyond the condition and diagnosis stated in the title, or the detailed treatment schedule for the test group. Those features should not be inferred from the reported group sizes or outcome results.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Control Group | CIK Immunotherapy Group |
|---|---|---|
| STARTED | 89 | 91 |
| COMPLETED | 73 | 74 |
| NOT COMPLETED | 16 | 17 |
Reasons for not completing this period:
| Reason | Control Group | CIK Immunotherapy Group |
|---|---|---|
| Withdrawal by Subject | 13 | 14 |
| Protocol Violation | 1 | 1 |
| Adverse Event | 2 | 2 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: From December 2008 to October 2012, a total of 188 patients were screened from 7 institutes in Korea, 8 patients failed in the screening process, and 180 patients were randomized.
| Characteristic | Unit | Control Group | CIK Immunotherapy Group | Total |
|---|---|---|---|---|
| Participants analysed | 89 | 91 | 180 | |
| Age, Continuous | years | 54.0 (23.0 to 68.0) | 55.0 (19.0 to 69.0) | 54.5 (19.0 to 69.0) |
| Sex: Female, Male: Female | Participants | 38 | 40 | 78 |
| Sex: Female, Male: Male | Participants | 51 | 51 | 102 |
| Region of Enrollment: South Korea | participants | 89 | 91 | 180 |
| Karnofsky performance scale | units on a scale | 90 (60.0 to 100.0) | 90.0 (60.0 to 100.0) | 90.0 (60.0 to 100.0) |
| Global health status/Quality of life | units on a scale | 50 (0.0 to 100) | 58 (8.0 to 100) | 54 (0.0 to 100) |
| Tumor size | centimeter | 1.4 (0.0 to 67.1) | 4.2 (0.0 to 28.2) | 2.8 (0.0 to 67.1) |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival(PFS), measured over From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 95% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival measures the time from randomization until the first documented disease progression or death from any cause, whichever occurs first. It therefore combines progression and death as events rather than measuring either outcome separately. The registry specifies a follow-up assessment period of up to 46 months.
For this trial, the primary outcome is reported as median progression-free survival in months. In general, a median time-to-event value is the time by which half of the observed population has experienced the defined event, subject to the analysis methods used. It describes the middle of the event-time distribution, not the average time and not the experience of every participant.
The registry says local investigators assessed progression using enhanced MRI. It lists an assessment approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3~12 months thereafter during follow-up. The timing and local assessment matter because the recorded date of progression depends on when it is assessed and documented. The specific rules for adjudicating progression or resolving differences in assessment are not reported in the registry record.
Progression-free survival is used in general as a time-to-event endpoint because it incorporates both whether an event occurs and when it occurs. For this trial, the posted medians and their confidence intervals summarize the primary endpoint by group. They do not provide a complete account of the event-time distributions or a direct estimate of the between-group treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted median progression-free survival is 5.4 months in the control group, with a 95% confidence interval from 3.3 to 7.9 months. In the CIK Immunotherapy Group, the posted median is 8.1 months, with a 95% confidence interval from 5.8 to 8.5 months. These are descriptive group-level results for the trial’s primary endpoint.
The median reported for the CIK Immunotherapy Group is larger than the median reported for the control group. That descriptive observation does not establish the size or statistical certainty of a between-group effect. The registry record does not report a hazard ratio, a confidence interval for a treatment contrast, or a p-value for progression-free survival. Without those comparative results, the posted medians alone do not show whether the observed difference is compatible with chance under a specified statistical model.
A 95% confidence interval communicates uncertainty around an estimated quantity. In general, it reflects the range of estimates compatible with the data under the method used to construct it; it is not a guarantee that the true value lies within the displayed limits. The intervals are attached separately to each group’s median. They should not be treated as a confidence interval for the difference between groups. A formal comparison requires the appropriate comparative estimate and its uncertainty, neither of which is reported in the registry record.
The registry reports 89 participants in the control group and 91 in the CIK Immunotherapy Group for these results. The record also reports 180 enrolled overall. The numbers contributing to each time point, the number of progression or death events, and the handling of participants without a recorded event are not reported in the registry record. Those details can affect interpretation of time-to-event estimates.
Overall survival is listed as a secondary outcome, but its result is not reported in the registry record. The listed count of analyses is zero, and no inferential analysis of the primary outcome is included in the record described. Thus, the available result supports a description of the group-specific medians and their intervals, but not a conclusion about statistical significance, adjustment, or the effect of treatment on survival.
9. Statistical Methods Explained
The registry reports a median time-to-event endpoint with a 95% confidence interval for each group. The reported values are 5.4 months (95% confidence interval 3.3 to 7.9) for the control group and 8.1 months (95% confidence interval 5.8 to 8.5) for the CIK Immunotherapy Group. The registry record does not identify the estimator or the procedure used to compare groups.
What does a median time-to-event value describe?
General explanation: a time-to-event outcome records both the occurrence of a defined event and the time until it occurs. For progression-free survival in this trial, the event is the first documented progression or death from any cause. A median time summarizes the center of the event-time distribution. It does not describe each participant’s individual course, and it is not an arithmetic average.
Time-to-event data can include participants whose event has not been observed by the end of their available follow-up. In general, these observations are censored: the analysis uses the time they were observed without the event, while their later event time remains unknown. The registry record does not report the censoring rules, the numbers censored, or the number of events in either group. It also does not state the estimator used to obtain the medians.
What does a confidence interval add?
General explanation: a confidence interval expresses uncertainty in an estimate under a statistical method and its assumptions. A narrower interval generally indicates greater precision than a wider interval for the same type of estimate. The intervals in this record describe uncertainty around the median for each group. They are not intervals for a direct contrast between the groups, and they do not replace a comparative analysis.
The interval for the control-group median is 3.3 to 7.9 months; the interval for the CIK Immunotherapy Group median is 5.8 to 8.5 months. Because the record supplies intervals for the separate group estimates, it does not directly quantify uncertainty in the difference between them. A treatment comparison in a time-to-event analysis is often expressed using a hazard ratio, a test statistic, or another prespecified contrast. No such primary-outcome result is reported in the registry record.
Why can time-to-event methods matter?
General explanation: time-to-event methods can account for participants who have different lengths of follow-up and for participants who have not experienced the event at their last observation. The methods depend on the event definition, follow-up, censoring, and analysis choices. If participants are lost to follow-up or have incomplete assessments, their data need to be handled under a stated approach. The registry record does not report the approach to missing outcome information or censoring for this trial.
The registry describes progression assessments by local investigators using enhanced MRI, at scheduled assessments and during later follow-up. Since progression is documented at assessments rather than continuously observed, the recorded event time is tied to the assessment and documentation process. The specific rules governing dates, review, and adjudication are not reported in the registry record. No independent central review is described in the available record.
What do the design and analysis details allow?
Randomization is intended in general to support a fair comparison by assigning participants to groups through a chance-based process. This record identifies the trial as randomized, but does not report the sequence-generation procedure, concealment process, or stratification factors. The study is open-label and lists no masking. That design feature is relevant when interpreting assessments made by local investigators, although the registry does not establish whether knowledge of assignment affected any assessment.
The trial is described as a parallel-group phase 3 study. The control and test-group descriptions make the intended treatment contrast clear at a broad level: Immuncell-LC was added to temozolomide-based treatment in the test group. They do not give a complete account of all treatment administration details. The registry record also does not report the planned statistical model, covariate adjustment, hypothesis test, significance threshold for the primary analysis, or analysis population.
Planning sample-size figures are illustrations based on the observed effect and the stated assumptions: two-sided significance level 0.05, equal allocation, and a normal approximation. They are planning illustrations, not observed power and not evidence that the trial was designed using those assumptions. The trial’s own sample-size justification is not reported in the registry record. The record does not list a hazard ratio for the primary outcome; any such sponsor-reported estimate is not included in the results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists progression-free survival as the primary outcome and overall survival as a secondary outcome. It reports no overall-survival result. Although it lists two outcome measures, the registry record does not describe a multiplicity strategy for testing more than one outcome or for handling multiple analyses, time points, or subgroups.
Multiplicity matters in general when several hypotheses are assessed: the chance of a false-positive finding can change depending on how many tests are conducted and how results are interpreted. The registry record does not report whether any adjustment was planned or applied. It also does not report a prespecified hierarchy of outcomes beyond identifying progression-free survival as primary and overall survival as secondary.
Details about missing data and analysis populations are not reported in the registry record. In particular, the record does not state whether the primary analysis used all randomized participants, an intention-to-treat population, a per-protocol population, or another defined group. It does not describe exclusions, losses to follow-up, missing MRI assessments, imputation, or censoring rules. These details are relevant to understanding which participants contributed to the estimates and how incomplete follow-up was handled.
The registry lists zero analyses and does not report a primary-outcome p-value, hazard ratio, or comparative confidence interval. It also does not report interim analyses, stopping rules, or the statistical analysis plan. Consequently, the posted medians should be read as descriptive results rather than as a complete inferential account of the trial’s planned comparisons.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Control Group | 31 | 89 | 34.8% |
| Test Group | 35 | 91 | 38.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Control Group | 52 of 89 |
| Test Group | 51 of 91 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Control Group | 83 of 89 |
| Test Group | 84 of 91 |
Most frequent serious adverse event terms
| Event term | Organ system | Control Group | Test Group |
|---|---|---|---|
| Convulsion | Nervous system disorders | 3 of 89 | 6 of 91 |
| Headache | Nervous system disorders | 5 of 89 | 4 of 91 |
| pneumonia | Infections and infestations | 4 of 89 | 3 of 91 |
| Brain edema | Nervous system disorders | 2 of 89 | 4 of 91 |
| Hemiparesis | Nervous system disorders | 4 of 89 | 2 of 91 |
| Hydrocephalus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 2 of 89 | 3 of 91 |
| pyrexia | General disorders | 2 of 89 | 2 of 91 |
| Mental impairment | Nervous system disorders | 3 of 89 | 0 of 91 |
| asthenia | General disorders | 1 of 89 | 2 of 91 |
| decreased appetite | Metabolism and nutrition disorders | 0 of 89 | 3 of 91 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Control Group | Test Group |
|---|---|---|---|
| Decreased appetite | Metabolism and nutrition disorders | 50 of 89 | 54 of 91 |
| Alopecia | Skin and subcutaneous tissue disorders | 51 of 89 | 51 of 91 |
| Nausea | Gastrointestinal disorders | 52 of 89 | 46 of 91 |
| Constipation | Gastrointestinal disorders | 31 of 89 | 32 of 91 |
| Vomiting | Gastrointestinal disorders | 28 of 89 | 34 of 91 |
| Headache | Nervous system disorders | 29 of 89 | 28 of 91 |
| Nasopharyngitis | Infections and infestations | 23 of 89 | 25 of 91 |
| Pyrexia | General disorders | 14 of 89 | 27 of 91 |
| Dyspepsia | Gastrointestinal disorders | 20 of 89 | 16 of 91 |
| Asthenia | General disorders | 16 of 89 | 14 of 91 |
Serious events with the highest arm-level rate: convulsion (6.6%), headache (5.6%), hemiparesis (4.5%), pneumonia (4.5%), brain edema (4.4%).
The registry reports serious adverse events for 31 of 89 participants in the control group and 35 of 91 participants in the test group. For other adverse events, it reports 83 of 89 participants in the control group and 84 of 91 participants in the test group. The recorded death counts are 52 and 51, respectively. The record does not provide a detailed explanation of the death measure or its observation period in the listed safety results.
These figures describe the counts recorded in each group; they do not by themselves establish that treatment caused an event or that risks differed between groups. The registry does not report a comparative safety estimate, confidence interval, or statistical test for these counts. It also does not give event-level timing, duration, severity grading, attribution to study treatment, or the rules used to classify events in the information described.
The registry lists serious adverse event terms with percentages: convulsion, 6.6%; headache, 5.6%; hemiparesis, 4.5%; pneumonia, 4.5%; brain edema, 4.4%; and mental impairment, 3.4%. These terms should be read as reported safety entries, not as a complete account of all adverse events. The record does not specify the denominator or the precise counting basis for these listed percentages.
12. What the Result Does, and Does Not, Mean
The posted primary outcome describes median progression-free survival in each randomized group. The median is 5.4 months in the control group and 8.1 months in the CIK Immunotherapy Group, with a 95% confidence interval reported for each. The descriptive comparison is that the group receiving Immuncell-LC has the larger reported median. The record does not provide the comparative analysis needed to quantify uncertainty around that contrast.
These results do not, on their own, establish that Immuncell-LC changed progression-free survival. No primary-outcome hazard ratio, comparative confidence interval, or p-value is reported in the registry record. The group-specific medians cannot substitute for those statistics, and the confidence intervals around each median do not directly answer whether the groups differ under a defined statistical test.
The results also do not establish an overall-survival effect. Overall survival appears as a secondary outcome, but no result is reported in the registry record. The safety counts and listed serious adverse event terms describe recorded events; without comparative analyses and fuller event information, they do not determine whether the treatment caused particular events or how the groups’ safety profiles compare.
Interpretation is further limited by missing information about analysis populations, censoring, missing assessments, the statistical plan, and multiplicity. The open-label design and local investigator assessment of progression are relevant features of the trial, but the record does not report whether treatment knowledge influenced assessment. The posted findings can therefore be used to describe the reported group medians and safety counts, not to make a definitive claim about treatment benefit, harm, or the certainty of a between-group effect.
13. Why This Trial Matters Statistically
This trial illustrates why a randomized design and a reported treatment contrast do not tell the entire statistical story. Randomization creates the basis for comparing groups, but interpretation also depends on the outcome definition, how follow-up is handled, which participants are analyzed, and whether the results include an estimate of the between-group effect with its uncertainty.
Progression-free survival is a time-to-event endpoint, and the registry reports group-specific medians with confidence intervals. Those summaries are useful for describing the center of the observed event-time distributions. They do not give the same information as a hazard ratio or another direct comparative estimate. The absence of a reported comparative result is particularly important when readers want to understand the magnitude and precision of the treatment contrast rather than just each group’s median.
The record also shows why outcome and safety summaries need context. Overall survival is listed as secondary, but no result appears in the registry record. Serious and other adverse-event counts are posted, but no comparative safety analysis is reported. Missing details about analysis populations, censoring, and handling of missing assessments leave uncertainty about how the outcome estimates were constructed.
For clinical researchers and biostatisticians, the distinction between a descriptive result and an inferential comparison is central. The available registry information supports reporting the observed medians, confidence intervals, and safety counts as recorded. It does not support filling gaps with assumed methods or treating an observed difference between medians as a formal statistical conclusion.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The registry record does not report a hazard ratio or other direct estimate for the primary comparison, nor a p-value or confidence interval for a between-group contrast. It therefore gives limited information about the statistical precision of the comparative result. The posted confidence intervals relate to the separate group medians, not to a treatment effect estimate.
Several methods details are also absent: the statistical model and estimator, the planned hypothesis test, any covariate adjustment, the analysis population, and the approach to censoring and missing assessments. The record does not state how many progression or death events contributed to the analysis, how many participants were censored, or how incomplete follow-up was handled. The trial’s sample-size justification and any interim-analysis plan are not reported in the registry record.
Progression was assessed locally by investigators using enhanced MRI. The registry does not report central review, adjudication procedures, or the rules for determining progression dates. Since the trial was open-label, assessment was not masked according to the registry description; the record does not establish whether that affected outcome assessment.
The test-group description does not give a complete Immuncell-LC administration schedule. The registry lists overall survival as secondary but does not report its result. Safety information includes group counts and selected serious adverse event terms, but lacks a comparative analysis and further details about timing, attribution, and counting. These limitations constrain conclusions about efficacy, safety, and the precision of any between-group difference.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Trial to Assess the Efficacy and Safety of 'Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea — NCT00807027.
- Registry record last updated 2025-10-10; status last verified 2025-09.
- Results first posted 2025-10-10.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed, multicenter, randomized, open-label, parallel-group phase 3 trial of Immuncell-LC with temozolomide-based treatment in newly diagnosed glioblastoma. It lists 180 enrolled participants. The control group received temozolomide and radiation therapy followed by temozolomide alone; the test group received Immuncell-LC in addition to treatment described as the same as control.
Progression-free survival was the primary outcome. The posted median is 5.4 months (95% confidence interval 3.3 to 7.9) in the control group and 8.1 months (95% confidence interval 5.8 to 8.5) in the CIK Immunotherapy Group. Overall survival is listed as secondary, but its result is not reported in the registry record. Safety counts are listed for serious and other adverse events and for deaths.
A direct comparative estimate for progression-free survival, analysis-population details, missing-data methods, and the trial’s statistical analysis plan are not reported in the registry record. The posted outcome values therefore describe group-specific results without establishing a formal statistical conclusion about the treatment contrast.