Trial Outcomes & Findings for A Trial of Systemic Chemotherapy in Combination With Conventional Transarterial Chemoembolization in Patients With Advanced Intra-Hepatic Cholangiocarcinoma (NCT NCT02994251)
NCT ID: NCT02994251
Last Updated: 2019-12-30
Results Overview
The primary objective of this study is to evaluate the 12-month progression-free survival (PFS) rate in adult patients with intrahepatic cholangiocarcinoma (ICC) after treatment with gemcitabine and cisplatin in combination with conventional TACE. This is the percentage of patients alive and free of progression at 12-months from enrollment on study. Radiographic assessment of disease burden will be evaluated by mRECIST and qEASL using an MRI scan obtained at the IR clinic visit.
TERMINATED
PHASE2
1 participants
12 months
2019-12-30
Participant Flow
Participant milestones
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All Subjects
Patients must have advanced, unresectable intrahepatic cholangiocarcinoma (ICC) defined as biopsy-confirmed adenocarcinoma in the liver, with an immunohistochemical profile consistent with a pancreatico-biliary primary, not involving the common bile duct or bifurcation, and not amenable to surgical resection.
gemcitabine: 1000 mg/m\^2 of gemcitabine on Day 1 and 8, Dosages may be modified or delayed due to toxicities
Cisplatin: 25 mg/m\^2 on Day 1 and 8, Dosages may be modified or delayed due to toxicities
Conventional TACE (transarterial chemoembolization) with Doxorubicin/Mitomycin-C: If conventional transarterial chemoembolization (TACE) is warranted based on MRI assessment and the patient meets all the eligibility criteria for TACE therapy, then cTACE will be scheduled to take place during Week 3 of that cycle. Patients will always receive the first cTACE for study; follow-up cTACE will occur on demand.
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Systemic Chemotherapy in Combination With Conventional Transarterial Chemoembolization in Patients With Advanced Intra-Hepatic Cholangiocarcinoma
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.
The primary objective of this study is to evaluate the 12-month progression-free survival (PFS) rate in adult patients with intrahepatic cholangiocarcinoma (ICC) after treatment with gemcitabine and cisplatin in combination with conventional TACE. This is the percentage of patients alive and free of progression at 12-months from enrollment on study. Radiographic assessment of disease burden will be evaluated by mRECIST and qEASL using an MRI scan obtained at the IR clinic visit.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.
Evaluation of overall survival (OS) of adult patients with advanced ICC treated with gemcitabine and cisplatin in combination with conventional TACE. Overall survival is the time from enrollment on study until death of the patient from any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.
Overall TTP is the time from enrollment on study until radiographic evidence of overall disease progression. Radiographic assessment will be evaluated by mRECIST using MRI every 2 cycles after intra-arterial therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 18 monthsPopulation: Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.
TTUP in liver lesions is measured from the time of initiation on cTACE therapy until radiographic evidence of disease progression in targeted lesions. Radiographic assessment will be evaluated by mRECIST using MRI every 2 cycles after intra-arterial therapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.
To evaluate the toxicities of the gemcitabine and cisplatin regimen in combination with cTACE therapy in adult patients with advanced ICC. Safety will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.
early changes in dynamic contrast-enhanced MRI (DCE-MRI) will correlate with long term PFS or OS, specifically as they relate to lesions targeted with cTACE therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 18 monthsPopulation: Confidentiality is a concern as the study was terminated after 1 patient was enrolled, thus any reported data would indicate PHI for this subject. To prevent this, it was advised to enter 0 as the number of participants analyzed.
early changes in dynamic contrast-enhanced MRI (DCE-MRI) will correlate with long term OS, specifically as they relate to lesions targeted with cTACE therapy
Outcome measures
Outcome data not reported
Adverse Events
All Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place