Trial · NCT07889232
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety of adding Tocilizumab to Standard of Care Immunotherapy | From Day 1 of treatment through completion of Cycle 4 (approximately 12 weeks) | Safety: Incidence of grade ≥3 non-hematological treatment-related adverse events (TRAEs) or autoimmune toxicities. Unacceptable toxicity is defined as more than 30% incidence of grade ≥3 serious adverse events (AEs), assessed by clinical and laboratory evaluation per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
| Primary | Progression-Free Survival Rate | 6 months after after initiation of study treatment | Progression-Free Survival Rate at 6 months: Time from Day 1 of treatment to documented disease progression or death, assessed at 6 months per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and calculated using Kaplan Meier statistics. |
| Primary | Feasibility of Treatment Completion | From Day 1 of treatment through completion of Cycle 4 (approximately 12 weeks) | Proportion of patients completing four cycles of treatment. Feasibility is defined as ≥80% of patients completing all four cycles. |
| Secondary | Weight Change | Baseline to EOT (approximately 3 months) | Measured from baseline to end of treatment (EOT) using objective weight data. |
| Secondary | Muscle Mass | at baseline and EOT (30 +/- 7 days post last dose) | Assessed via Computed Tomography (CT) -based analysis at baseline and end of treatment. |
| Secondary | Overall Response Rate (ORR) | at EOT (approximately 3 months) | Defined as complete response (CR) + partial response (PR) per RECIST 1.1 at end of treatment. |
| Secondary | Median Overall Survivial Rate | From Day 1 of treatment until death or last follow-up (up to 12 months post-EOT) | Time from Day 1 of treatment to the point at which 50% of participants have died and 50% remain alive. |
| Secondary | Inflammatory Biomarkers | From baseline to EOT (30 +/- 7 days post last dose) | Changes in C-Reactive Protein (CRP) levels from baseline to end of treatment. |
| Secondary | Sarcopenia | at baseline and EOT (30 +/- 7 days post last dose) | Assessed via CT-based analysis at baseline and end of treatment. |
| Other | Correlation between Baseline IL-6 and Overall Response Rate (ORR) | Baseline | Evaluation of the association between baseline Interleukin-6 (IL-6) concentration and Objective Response Rate (ORR). |
| Other | Correlation between Baseline CRP and Overall Response Rate (ORR) | Baseline | Assessment of the relationship between baseline C-reactive protein (CRP) levels and ORR. |
| Other | Correlation between Baseline PTPRT Methylation and Overall Response Rate (ORR) | Baseline | Assessment of the association between baseline PTPRT methylation status and ORR. |
| Other | Correlation between Baseline KRAS Mutation Status and Overall Response Rate (ORR) | Baseline | Evaluation of the correlation between KRAS tumor mutational status at baseline and ORR. |
| Other | Correlation between Baseline STK11 Mutation Status and Overall Response Rate (ORR) | Baseline | Evaluation of the correlation between baseline STK11 tumor mutational status and ORR. |
| Other | Correlation between Baseline IL-6 and PFS | Baseline | Evaluation of the association between baseline IL-6 concentration and Progression-Free Survival (PFS). |
| Other | Correlation between Baseline CRP and PFS | Baseline | Assessment of the relationship between baseline CRP concentration and PFS. |
| Other | Correlation between Baseline PTPRT Methylation and PFS | Baseline | Assessment of the association between baseline PTPRT methylation status and PFS. |
| Other | Correlation between Baseline KRAS Mutation Status and PFS | Baseline | Evaluation of the correlation between KRAS mutation status at baseline and PFS. |
| Other | Correlation between Baseline STK11 Mutation Status and PFS | Baseline | Evaluation of the association between baseline STK11 mutation status and PFS. |
| Other | Correlation between Longitudinal IL-6 Changes and Overall Response Rate (ORR) | Baseline through End of Treatment (30 +/- 7 days post last dose) | Analysis of whether changes in IL-6 levels measured at Baseline, C1D1, C2D1, C3D1, C4D1, and End of Treatment correlate with ORR. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT07889232/registered