Trial · NCT06893380
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | Up to 24 months after treatment initiation. | The proportion of patients who achieve a complete response (CR) or partial response (PR) according to RECIST v1.1. |
| Secondary | Overall Survival (OS) | Up to 36 months after treatment initiation. | Time from the date of first dose to the date of death from any cause. |
| Secondary | Progression-Free Survival (PFS) | Up to 24 months after treatment initiation. | Time from the date of first dose to disease progression per RECIST v1.1 or death from any cause. |
| Secondary | Disease Control Rate (DCR) | Up to 24 months after treatment initiation. | The proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1. |
| Secondary | Duration of Response (DOR) | Up to 24 months after treatment initiation. | Time from first documented response (CR or PR) to progression or death. |
| Secondary | Quality of Life (QoL)- EORTC QLQ-C30 | Up to 24 months after treatment initiation. | Patient-reported quality of life assessed using the EORTC QLQ-C30 questionnaire. |
| Secondary | Quality of Life (QoL)- EORTC QLQ-BIL21 | Up to 24 months after treatment initiation. | Patient-reported quality of life assessed using the EORTC QLQ-BIL21 questionnaire. |
| Secondary | Safety and Tolerability | Up to 30 days after last dose. | Incidence, severity, and type of adverse events (AEs), graded per NCI CTCAE v5.0. |
| Other | Immune System Response and Immunomodulation Markers | Baseline, during treatment (every 3 cycles; each cycle = 21 days), and at progression (up to 24 months) | Changes in immune system markers in peripheral blood and tumor tissue samples, including: CD8+ T-cell count (%) PD-L1 expression levels in tumor tissues Cytokine levels (e.g., IFN-γ, IL-6, TNF-α) T-cell receptor (TCR) clonality |
| Other | Metabolic Biomarker Changes in Peripheral Blood and Tumor Tissues | Baseline, during treatment, and at progression (up to 24 months) | Changes in metabolic biomarkers in peripheral blood and tumor tissue samples, including: Serum glucose levels (mg/dL) and insulin resistance markers (e.g., HOMA-IR) Lipid metabolism markers (e.g., triglycerides, total cholesterol, LDL, HDL) Lactate and pyruvate levels as indicators of altered tumor metabolism Amino acid profiling (e.g., glutamine, alanine) for metabolic reprogramming |
| Other | Collection and Storage of DNA and RNA for Future Exploratory Study | Baseline and during treatment (up to 24 months) | To collect and store DNA and RNA (following ethical guidelines) for future exploratory research investigating genetic variations that may affect responses to study treatment (distribution, safety, tolerability, and efficacy) and/or susceptibility to diseases. Participation in this exploratory study is optional. |
| Other | Quality of Life (QoL) - EORTC QLQ-C30 | Baseline, every 3 cycles during treatment (each cycle = 21 days), and at the end of treatment (up to 24 months) | Patient-reported quality of life assessed using the EORTC QLQ-C30 questionnaire, which evaluates physical, emotional, cognitive, and social functioning. |
| Other | Quality of Life (QoL) - EORTC QLQ-BIL21 | Baseline, every 3 cycles during treatment (each cycle = 21 days), and at the end of treatment (up to 24 months) | Patient-reported quality of life specific to biliary tract cancer, assessed using the EORTC QLQ-BIL21 questionnaire, which measures biliary cancer-related symptoms such as jaundice, pain, and fatigue |
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.
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