Trans-arterial treatment of patients with intra-hepatic cholangiocarcinoma not amenable to resection (TOMCAT)

Conditions

Intra-hepatic cholangiocarcinoma

Brief summary

Median survival time

Detailed description

Proportion of patients surviving 1 year, 2 years, Tumour response rate (CT scans, RECIST 1.1) (best response registered at any time): Proportion of patients with Partial Response, proportion of patients with Stable Disease, duration of Stable Disease and proportion of patients converted to resectability following downstaging, Change in HR-QoL (EORTC QLQ-C30 and EQ-5D-5L) from baseline to end-of-treatment, Change in ctDNA from baseline to end-of-treatment, Assess circulating cell-free DNA (ctDNA) before and after treatment and correlate with treatment outcomes, Evaluate tumour heterogeneity, based on whole exome sequencing of multiple tumour biopsies obtained at surgery for pump placement or during laparoscopic staging. The genomic findings will be used to stratify patients with respect to response and survival, and will also be used to quantify the degree of tumour heterogeneity., ctDNA and tumour genomic heterogeneity results will be further correlated with texture variables extracted from pre-treatment, contrast-enhanced CT scans.

Related papers

No related papers found yet.

Interventions

DRUGHEPARIN

DRUGOXALIPLATIN

DRUGFloxuridine

DRUGDEXAMETHASONE SODIUM PHOSPHATE

DRUGGEMCITABINE HYDROCHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Median survival time	—

Secondary

Measure	Time frame
Proportion of patients surviving 1 year, 2 years, Tumour response rate (CT scans, RECIST 1.1) (best response registered at any time): Proportion of patients with Partial Response, proportion of patients with Stable Disease, duration of Stable Disease and proportion of patients converted to resectability following downstaging, Change in HR-QoL (EORTC QLQ-C30 and EQ-5D-5L) from baseline to end-of-treatment, Change in ctDNA from baseline to end-of-treatment, Assess circulating cell-free DNA (ctDNA) before and after treatment and correlate with treatment outcomes, Evaluate tumour heterogeneity, based on whole exome sequencing of multiple tumour biopsies obtained at surgery for pump placement or during laparoscopic staging. The genomic findings will be used to stratify patients with respect to response and survival, and will also be used to quantify the degree of tumour heterogeneity., ctDNA and tumour genomic heterogeneity results will be further correlated with texture variables extracted	—

Measure

Time frame

Proportion of patients surviving 1 year, 2 years, Tumour response rate (CT scans, RECIST 1.1) (best response registered at any time): Proportion of patients with Partial Response, proportion of patients with Stable Disease, duration of Stable Disease and proportion of patients converted to resectability following downstaging, Change in HR-QoL (EORTC QLQ-C30 and EQ-5D-5L) from baseline to end-of-treatment, Change in ctDNA from baseline to end-of-treatment, Assess circulating cell-free DNA (ctDNA) before and after treatment and correlate with treatment outcomes, Evaluate tumour heterogeneity, based on whole exome sequencing of multiple tumour biopsies obtained at surgery for pump placement or during laparoscopic staging. The genomic findings will be used to stratify patients with respect to response and survival, and will also be used to quantify the degree of tumour heterogeneity., ctDNA and tumour genomic heterogeneity results will be further correlated with texture variables extracted

—

Countries

Norway

Outcome results

None listed