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Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cholestasis, Progressive Familial Intrahepatic 3

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Trial Information

Efficacy and Tolerance of RADIOEMBOLIZATION for Patients With Unresectable Intrahepatic Cholangiocarcinoma With Tumor Progression After First-line Therapy


Extended description of the protocol, including information not already contained in other
fields, such as comparison studied.

It is a pilot study including 20 patients with unresectable intra-hepatic CCK in tumor
progression after first-line therapy.

Description of the protocol :

1. Information and signed CONSENTMENT

2. Preparatory phase : pre-treatment mesenteric angiography and technetium-99m
macroaggregated albumin scans are performed to assess gastrointestinal flow and lung
shunting.

3. Therapeutic phase : intra-arterial administration of resin-based microspheres (
SIRSPHERES, SIRTEX). The RE can be performed in 2 sessions, especially if liver disease
is bi-lobar.

4. Follow up to J15,M1,M2,M4 and M6 : clinical examination and imaging evaluation ( scans
and /or MRI)


Inclusion Criteria:



- Unresectable intra-hepatic CCK histologically proven

- Tumor progression documented on imaging evaluation ( CT or MRI) according to RECIST
criteria version 1.1 after first-line therapy

- Performance status < 2 ; 4) Bilirubin < 36 micromol/l

- age > 18 years

Exclusion Criteria:

- Extra-hepatic metastases

- Uncontrolled biliary obstruction

- Contra-indications to RE.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression -free survival at 6 months (from date of inclusion)

Outcome Description:

Progression -free survival defined by the number of patients alive at 6 months without tumor progression documented on imaging evaluation ( MRI or CT) using RECIST criteria version 1.1.

Outcome Time Frame:

6 months

Safety Issue:

Yes

Principal Investigator

Laetitia FARTOUX, MD,

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

P100701

NCT ID:

NCT01383746

Start Date:

October 2011

Completion Date:

June 2014

Related Keywords:

  • Cholestasis, Progressive Familial Intrahepatic 3
  • Cholangiocarcinoma
  • RADIOEMBOLIZATION
  • tumor response
  • progression-free survival
  • safety
  • second-line therapy
  • Cholestasis
  • Cholangiocarcinoma
  • Cholestasis, Intrahepatic

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