Low-Dose Radiation Therapy to the Whole Liver With Gemcitabine and Cisplatin in IHC

Recruiting in Palo Alto (17 mi)

Overseen bySrinevas K Reddy, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Allina Health System

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?The overall goal of this study is to determine the safety and efficacy of combination treatment of low-dose fractionated radiation therapy with gemcitabine-cisplatin chemotherapy for locally advanced mass forming intra-hepatic cholangiocarcinoma.

Eligibility Criteria

Inclusion Criteria

Histologic diagnosis of mass-forming IHC. OR Histologic diagnosis of adenocarcinoma of the liver in setting of negative colonoscopy, upper endoscopy, mammography (females), or cross-sectional imaging for primary disease.

Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm (≥1 cm) with spiral CT scan, MRI. See Section 8 for the evaluation of measurable disease.

Locally advanced disease (portal lymph node disease, multifocal intrahepatic lesions, or major vascular invasion) AND no evidence of omental, peritoneal, or pelvic metastases.

+7 more

Participant Groups

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment3 Interventions

Four three-week treatment cycles. Gemcitabine (1000 gm/m\^2) and cisplatin (25 mg/m\^2) administered on days one and eight of each cycle. Whole liver and portal lymph node basin low dose radiotherapy on days one, two, eight, and nine of each cycle.

Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Platinol for: