Treatment for Bile Duct Cancer in the Liver

Selective Internal Radiation Therapy With Yttrium-90 Resin Microspheres Followed by Gemcitabine Plus Cisplatin for Intra-hepatic Cholangiocarcinoma: A Phase II Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02167711

Enrollment

Registered

2014-06-19

Start date

2014-09-17

Completion date

2023-02-08

Last updated

2023-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangio Carcinoma

Brief summary

The current standard treatment of inoperable intrahepatic cholangiocarcinoma (bile duct cancer in the liver) is chemotherapy, which is of limited efficacy. The use of selective internal radiotherapy treatment (SIRT-Y90) is proven efficacious in patients with intra-heptic tumor. Previous experience with SIRT is safe in patients with intrahepatic cholangiocarcinoma. This study aims to study the benefits of sequential administration of SIRT followed by standard chemotherapy for treatment of inoperable intrahepatic cholangiocarcinoma.

Interventions

DRUGSIRT Yttrium-90

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age\>18 years * Histological or cytological diagnosis of cholangiocarcinoma * Disease not amenable to surgery * Predominant disease load in the liver (in case of extra-hepatic involvement, only patients with lymph nodes metastases are allowed) * Naïve to locoregional or systemic treatment (but patients who develop recurrent disease after surgery are suitable) * ECOG PS 0-1 * At least one measurable disease lesion according to RECIST v 1.1 * Life expectancy of 12 weeks or longer * Adequate hematological, renal and hepatic function * Platelet ≥100 x 109 * ANC ≥ 1.5 x 109 * Bilirubin ≤ 30µmol/L * Albumin ≥ 30g/L * ALT ≤ 3 ULN * INR ≤ 1.5 * Serum creatinine ≤ 1.5 x ULN

Exclusion criteria

* Prior malignancy except cervical carcinoma-in-situ or treated basal cell carcinoma. Any cancers treated curatively \> 5 years prior to study entry are permitted. * Patients with extra-hepatic disease other than regional lymph node metastases. * Evidence of ascites or cirrhosis, as determined by clinical or radiologic assessment * Biliary obstruction with no possibility of drainage * Non-malignant disease that would render the patient unsuitable for treatment according to the protocol * Prior treatment of chemotherapy for the cholangiocarcinoma * Prior radiation therapy to the upper abdomen * Complete thrombosis of the main portal vein * Tumor volume \> 50% of the normal liver volume * Allergy to non-ionic contrast agents

Design outcomes

Primary

Measure	Time frame
Overall survival	2 years

Secondary

Measure	Time frame
Radiological response	2 years
disease control rate	2 years
Progression-free survival	2 years
Rate and severity of toxicities	2 years
Serological response in CA 19.9	2 years
Duration between timing of chemotherapy and SIRT-Y90	2 years

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026