Intrahepatic Cholangiocarcinoma, Perihilar Cholangiocarcinoma
Conditions
Brief summary
Prospective observational cohort study including patients with a diagnosis of intrahepatic/perihilar cholangiocarcinoma at the central regional multidisciplinary conference, to assess therapy response, patient-reported quality of life, patient-reported symptoms/experiences and biomarkers. For patients diagnosed with localized unresectable disease, the study will document the multidisciplinary re-assessment of therapy response.
Interventions
None listed
Sponsors
Karolinska University Hospital
Karolinska Institutet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Clinical diagnosis of intrahepatic- or perihilar cholangiocarcinoma at the regional multidisciplinary team conference * For inclusion in the re-assessment arm, a diagnosis of localized, unresectable cholangiocarcinoma at the regional multidisciplinary team conference and clinically evaluated as candidate for tumor-directed medical therapy
Exclusion criteria
* Age \<18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of conversion to resectability, in patients with localized, unresectable cholangiocarcinoma | At first multidisciplinary re-assessment of therapy response after first-line oncological treatment (typically after 8 cycles, i.e. at an average of approximately 6 months) | Change of initial treatment intention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival time | From date of surgery until the date of clinical-radiological recurrence or date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years | For patients undergoing curative intent surgery |
| Progression-free survival time | From therapy starting date until date of first documented progression (recurrence, progressive disease acc. to Response Evaluation Criteria in Solid Tumor) or date of death of any cause, assessed at study completion with est. average follow-up 2 years | For patients with tumor-directed therapy. Assessment of progressive disease using Response Evaluation Criteria in Solid Tumor (RECIST criteria): Complete Response - disappearance of all target lesions. Partial Response - ≥30% decrease in sum of diameters. Progressive Disease - ≥20% increase in sum of diameters (minimum 5 mm absolute increase) or appearance of new lesions. Stable Disease: neither partial response nor progressive disease |
| Overall survival time | From date of diagnosis until the date of death of any cause, assessed at study completion at an estimated average follow-up of 2 years | — |
| Patient-reported quality of life according to the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion | 30 item questionnaire with 3 domains: symptoms, functional- and global health status. Items for symptoms and functioning are scored from 1-4 (symptoms - higher score represents higher level of symptomatology; function - higher score represents higher level of functioning). Items for global health status are scored from 1-7 (higher score represents a higher quality of life). Aggregated domain scores are calculated separately, and standardized to a range from 0 to 100, where a high score for symptoms represents a high level of symptomatology; while a high score for function and global health status represents a high level of functioning and a high quality of life. |
| Patient-reported symptoms/experiences according to the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire in Biliary Tract Cancer (EORTC QLQ-BIL21) | Sequentially: at inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment; before second treatment; 1 month after second treatment; at 6, 12, 18 and 24 months after inclusion | The EORTC QLQ-BIL21 questionnaire consists of 21 items: 3 single-question assessments (side effects, difficulties with biliary drainage, concerns regarding weight loss); and 18 questions aggregated into 5 symptom domains (eating, jaundice, tiredness, pain, anxiety). Each item is scored from 1-4 (higher score represents higher level of symptomatology). Symptom scores are transformed to a standardized range from 0 to 100, where a high score represents a high level of symptomatology. |
| Longitudinal assessment of circulating tumor DNA plasma concentration | At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion | tumor molecules / mL of plasma |
| Longitudinal assessment of plasma cytokine profile | At inclusion; 1 month after inclusion; before first treatment; 1 month after first treatment, and then every 2 months; before second treatment; 1 month after second treatment and then every 2 months up to 24 months after inclusion | Plasma cytokine concentrations (pg/mL) |
| Recurrence-free survival rate | At 6, 12, 18 and 24 months from the date of surgery | The proportion of patients with curative-intent surgery surviving without a clinical-radiological diagnosis of recurrence |
| Progression-free survival rate | At 6, 12, 18 and 24 months from the starting date of therapy | The proportion of patients with tumor-directed therapy surviving without documented progression (recurrence, progressive disease according to Response Evaluation Criteria in Solid Tumor \[RECIST criteria\]). RECIST criteria: Complete Response - disappearance of all target lesions. Partial Response - ≥30% decrease in sum of diameters. Progressive Disease - ≥20% increase in sum of diameters (minimum 5 mm absolute increase) or appearance of new lesions. Stable Disease: neither partial response nor progressive disease |
Contacts
CONTACTHannes Jansson, MD PhD
Outcome results
None listed