← Back to Search

Alkylating agents

Cisplatin-gemcitabine for Intrahepatic Cholangiocarcinoma (SIRCCA Trial)

Phase 2 & 3
Waitlist Available
Led By Jordi Bruix, MD
Research Sponsored by Sirtex Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first treatment until progression at any site, assessed up to 36 months.
Awards & highlights

SIRCCA Trial Summary

This trial will study whether adding SIRT to chemotherapy helps treat patients with unresectable intrahepatic cholangiocarcinoma.

Eligible Conditions
  • Intrahepatic Cholangiocarcinoma

SIRCCA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first treatment until progression at any site, assessed up to 36 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first treatment until progression at any site, assessed up to 36 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Survival at 18 months
Secondary outcome measures
Incidence of Adverse Events (Safety and tolerability)
Liver surgical resection and ablation rate
Liver-specific progression free survival (PFS)
+4 more

SIRCCA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Radiation: SIRT + chemotherapy (Cisplatin-Gemcitabine)Experimental Treatment2 Interventions
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.
Group II: Chemotherapy (Cisplatin-Gemcitabine)Active Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)
2017
Completed Phase 3
~90
Cisplatin-gemcitabine
2017
Completed Phase 3
~90

Find a Location

Who is running the clinical trial?

Sirtex MedicalLead Sponsor
28 Previous Clinical Trials
4,181 Total Patients Enrolled
Jordi Bruix, MDPrincipal InvestigatorHead of the Hepatic Oncology Unit, Hospital Clinic
3 Previous Clinical Trials
71 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
30 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Harpreet Wasan, MDPrincipal InvestigatorImperial College Healthcare Hammersmith Hospital
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma
2017. "SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02807181.
~11 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top