A Phase II Single-center, Open-label, Single Arm Study of Induction Gemcitabine, Cisplatin and Durvalumab Followed by Gemcitabine, Cisplatin and Yttrium-90 (Y-90) Radioembolization for the Treatment of Locally Advanced Unresectable Intrahepatic Cholangiocarcinoma

Inova Health Care Services1 site in 1 country16 target enrollmentJune 12, 2024

ConditionsIntrahepatic Cholangiocarcinoma

InterventionsInduction Chemotherapy Triplet Therapy Concurrent Y-90 treatment

DrugsInduction Chemotherapy Triplet Therapy Consolidation Doublet Therapy:

Overview

Phase: Phase 2
Intervention: Induction Chemotherapy Triplet Therapy
Conditions: Intrahepatic Cholangiocarcinoma
Sponsor: Inova Health Care Services
Enrollment: 16
Locations: 1
Primary Endpoint: Assessing the objective response rate (ORR) at 6 months in patients with locally advanced, unresectable intrahepatic cholangiocarcinoma (iCCA)
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this research is to see if combining gemcitabine, cisplatin and Durvalumab chemotherapy treatments with a direct tumor therapy called Yittrium-90, will work better together to shrink the tumor and control cancer.

Registry

clinicaltrials.gov

Start Date

June 12, 2024

End Date

September 30, 2028

Last Updated

9 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Inova Health Care Services

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult males and females at least 18 years of age
•Histologically and/or cytologically confirmed iCCA that is previously untreated or, if systemic therapy has been rendered for prior disease, has been administered at least 6 months before the development of recurrent or de novo new sites of disease.
•Unresectable disease, as deemed by the Inova multidisciplinary tumor board (i.e. disease that cannot be safely resected with negative margins, leaving 2 adjacent segments of liver with intact portal venous and hepatic arterial inflow and intact biliary and hepatic venous outflow with the future liver remnant of sufficient volume to avoid postoperative liver insufficiency)
•Measurable disease per RECIST 1.1 at least 2 cm in size
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
•Noncirrhotic liver - patients should not have a preexisting diagnosis of cirrhosis either diagnosed via biopsy or with features consistent with cirrhosis on imaging (e.g. shrunken liver with nodularity consistent with cirrhosis). Child-Pugh score must be less than
•No evidence of extrahepatic disease, except for regional adenopathy that would be resected as part of a standard oncologic surgical procedure
•Adequate organ function as indicated by the following laboratory values (Table 1)
•Ability to complete testing in the protocol
•Able and willing to consent to protocol

Exclusion Criteria

•Female patients who are pregnant or breast-feeding
•History of allogeneic organ transplantation.
•Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with the following exceptions:
•Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.
•Patients with controlled type 1 diabetes on an insulin regimen are eligible for the study.
•Patients with vitiligo or alopecia.
•Any chronic skin condition that does not require systemic therapy.
•Patients without an active autoimmune disease in the last 5 years may be included but only after consultation with the study physician.
•Patients with diet controlled celiac disease.
•Current or recent use of immunosuppressive medication within 14 days before durvalumab initiation except if:

Arms & Interventions

gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90

single arm - Induction Gemcitabine, Cisplatin and Durvalumab Triplet Chemotherapy followed by Gemcitabine, Cisplatin in combination with yttrium-90 (Y-90) Radioembolization

Intervention: Induction Chemotherapy Triplet Therapy

gemcitabine, cisplatin and Durvalumab chemotherapy with Yittrium-90

single arm - Induction Gemcitabine, Cisplatin and Durvalumab Triplet Chemotherapy followed by Gemcitabine, Cisplatin in combination with yttrium-90 (Y-90) Radioembolization

Intervention: Concurrent Y-90 treatment