A Trial of Systemic Chemotherapy in Combination With Conventional Transarterial Chemoembolization in Patients With Advanced Intra-Hepatic Cholangiocarcinoma
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|ClinicalTrials.gov Identifier: NCT02994251|
Recruitment Status : Recruiting
First Posted : December 15, 2016
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Unresectable Intrahepatic Cholangiocarcinoma||Drug: gemcitabine Drug: Cisplatin Drug: Conventional TACE (transarterial chemoembolization) with Doxorubicin/Mitomycin-C||Phase 2|
Eligible patients enrolled on study will receive a chemotherapy regimen of gemcitabine and cisplatin administered intravenously on Days 1 and 8 of a 21-day cycle. After every 2 cycles of systemic chemotherapy, patients will receive contrast-enhanced MRI to assess liver disease; conventional trans-arterial chemoembolization (TACE) will be performed as indicated based on this assessment. Patients will receive a maximum of 8 cycles of the gemcitabine/cisplatin combination. Up to 3 TACE treatments may be delivered in this same time frame, with the first TACE taking place after 2 cycles of systemic chemotherapy. Following the treatment period, patients will continue clinical follow-up at 3 month intervals until study exit at 18 months post the start of treatment.
It is hypothesized that the addition of conventional transarterial chemoembolization to standard chemotherapy will result in an improvement in PFS in patients with advanced, unresectable ICC, including patients with extra-hepatic disease.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Systemic Chemotherapy (Gemcitabine and Cisplatin) in Combination With Conventional Transarterial Chemoembolization (cTACE) in Patients With Advanced Intra-Hepatic Cholangiocarcinoma (ICC)|
|Actual Study Start Date :||December 2016|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: 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.
1000 mg/m^2 of gemcitabine on Day 1 and 8, Dosages may be modified or delayed due to toxicities
25 mg/m^2 on Day 1 and 8, Dosages may be modified or delayed due to toxicities
Drug: 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.
- progression-free survival [ Time Frame: 12 months ]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.
- overall survival [ Time Frame: 18 months ]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.
- overall time to progression (TTP) [ Time Frame: up to 18 months ]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.
- time to untreatable progression (TTUP) [ Time Frame: up to 18 months ]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.
- toxicities of the gemcitabine and cisplatin regimen in combination with cTACE therapy using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. [ Time Frame: 18 months ]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.
- correlation between changes in dynamic contrast-enhanced MRI of liver lesions and progression free survival [ Time Frame: 18 months ]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
- correlation between changes in dynamic contrast-enhanced MRI of liver lesions and overall survival [ Time Frame: 18 months ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994251
|Contact: Todd Schlachter, MD||+1 (203) email@example.com|
|Contact: Eliot Funai||(203) firstname.lastname@example.org|
|United States, Connecticut|
|Smilow Cancer Center||Recruiting|
|New Haven, Connecticut, United States, 06510|
|Contact: Todd Schlachter, MD 203-785-4747 email@example.com|
|Sub-Investigator: Hyun Kim, MD|
|Sub-Investigator: Stacey Stein, MD|
|Sub-Investigator: Howard S Hochster, MD|
|Sub-Investigator: Jill Lacy, MD|
|Sub-Investigator: Jeffrey Pollak, MD|
|Principal Investigator:||Todd Schlachter||Yale University|