SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma (SIRCCA)
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|ClinicalTrials.gov Identifier: NCT02807181|
Recruitment Status : Recruiting
First Posted : June 21, 2016
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Intrahepatic Cholangiocarcinoma||Drug: Cisplatin-gemcitabine Device: Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)||Phase 2 Phase 3|
This clinical study is a prospective, multicenter, randomized, controlled study evaluating SIR-Spheres Y-90 resin microspheres followed by cisplatin-gemcitabine (CIS-GEM) chemotherapy vs. CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic cholangiocarcinoma.
Randomized patients will be followed until death, withdrawal of consent, or until end of study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Active Comparator: Chemotherapy (Cisplatin-Gemcitabine)
Cisplatin 25mg/m2 in 1000ml 0.9% saline given over 1 hour followed by 500 ml 0.9% saline over 30 minutes, followed by Gemcitabine 1000 mg/m2 in 250-500 ml 0.9% saline over 30 minutes by intravenous infusions on days 1, and 8 of a 21-day cycle.
Other Name: CIS-GEM
Experimental: Radiation: SIRT + chemotherapy (Cisplatin-Gemcitabine)
A single treatment of hepatic arterial injection of SIR-Spheres Y-90 resin microspheres (SIRT) followed 14-16 days later by systemic chemotherapy (ABC-02 CIS-GEM protocol) with an intention to treat with 8 cycles of cisplatin + gemcitabine, or until progression, toxicity or patient choice. Treatment may be continued beyond 8 cycles in the absence of significant disease progression, at the treating clinicians' discretion.
Other Name: CIS-GEM
Device: Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
SIR-Spheres microspheres followed by systemic chemotherapy
- Survival at 18 months [ Time Frame: 18 months following the date of randomization. ]Survival at 18 months is defined as the proportion of patients still alive 18 months from the date of randomization.
- Liver-specific progression free survival (PFS) [ Time Frame: From date of randomization to the first documented date of progression in the liver or date of death from any cause, assessed up to 36 months.. ]
- Progression free survival (PFS) at any site [ Time Frame: From date of randomization to the date of progression at any site until the first date of documented tumor progression at any site or date of death from any cause, assessed up to 36 months. ]
- Objective response rate by RECIST 1.1 and refined RECIST - liver [ Time Frame: From the date of first treatment until the date of date of first documented progression in the liver, assessed up to 36 months. ]
- Objective response rate by RECIST 1.1 and refined RECIST - at any site [ Time Frame: From the date of first treatment until progression at any site, assessed up to 36 months. ]
- Overall Survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 36 months. ]
- Liver surgical resection and ablation rate [ Time Frame: 18 months following the date of randomization. ]To assess the number of patients in each arm who are downstaged by protocol therapy and can proceed to liver resection or ablation. The specific assessments will be the classification of resection as R0, R1 or R2, the presence of viable tumor or fibrosis, and the nearest resection margin.
- Incidence of Adverse Events (Safety and tolerability) [ Time Frame: Informed consent until 28 days post last dose of protocol chemotherapy. ]Adverse events as assessed by CTCAE v. 4.0.
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): NCT02807181
|Contact: Fabio Niccolini||39 345 903 firstname.lastname@example.org|
Show 43 Study Locations
|Principal Investigator:||Jordi Bruix, MD||Head of the Hepatic Oncology Unit, Hospital Clinic|
|Principal Investigator:||Harpreet Wasan, MD||Imperial College Healthcare Hammersmith Hospital|