NL-OMON47572
Completed
Phase 2
A prospective, multicentre, randomised, controlled study evaluating SIR-Spheres® Y-90 resin microspheres preceding standard cisplatin-gemcitabine (CIS-GEM) chemotherapy versus CIS-GEM chemotherapy alone as first-line treatment of patients with unresectable intrahepatic CholangioCArcinoma. - SIRCCA
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- billiary tract cancer
- Sponsor
- Sirtex Technology Pty Ltd
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •a) Willing, able and mentally competent to provide written informed consent
- •b) Aged 18 years or older
- •c) Histologically or cytologically confirmed unresectable and/or non ablatable
- •intrahepatic cholangiocarcinoma
- •d) Liver\-only or liver predominant intrahepatic cholangiocarcinoma. Patients
- •are permitted to have loco\-regional lymph node involvement defined as: portal
- •LN \* 2 cm and/or para aortic LN \* 1\.5 cm in longest diameter, and/or up to 2
- •indeterminate lung lesions \< 1 cm if these lung lesions are PET negative.
- •e) Chemotherapy naïve. Adjuvant chemotherapy is not permitted
- •f) ECOG performance status 0 or 1,
Exclusion Criteria
- •a) Patients with only non\-measurable lesions in the liver according to RECIST
- •b) Incomplete recovery from previous liver surgery, e.g. unresolved biliary
- •tree obstruction or biliary sepsis or inadequate liver function
- •c) Biliary stenting in situ
- •d) Main trunk Portal Vein Thrombosis (PVT)
- •e) Ascites, even if controlled with diuretics. (A minor peri\-hepatic rim of
- •ascites detected at imaging is acceptable.)
- •f) Mixed HCC\-ICC disease.
- •g) History of prior malignancy. Exceptions include in\-situ carcinoma of the
- •cervix treated by cone\-biopsy/resection, non\-metastatic basal and/or squamous
Outcomes
Primary Outcomes
Not specified
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