Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT07110233
Brief Summary:
This is a prospective, single-blinded, single-arm, open-label Phase II trial of trans-arterial radiation segmentectomy using Yttrium-90 glass microspheres (TheraSphere®) for Hepatocellular Carcinoma (HCC) participants with unresectable Barcelona clinic liver cancer (BCLC) stage A disease.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the objective response rate (ORR) after radiation segmentectomy in participants with BCLC Stage A HCC and 1) a single solitary tumor measuring 2-5 centimeters (cm) and 2) 2 or 3 lesions each ≤ 3 cm.
II. To assess the safety of radiation segmentectomy.
SECONDARY OBJECTIVES:
I. To evaluate transplant-free survival.
II. To evaluate progression-free survival.
III. To evaluate the quality of life of participants.
IV. To evaluate the best imaging response. V. To determine the proportion of participants who remain active on the wait list for liver transplant and eventually are transplanted.
VI. The evaluate the number of participants that need additional treatment after TheraSphere® administration.
VII. Complete pathologic response (CPN) on liver explants among participants who underwent liver transplant.
Participants will undergo a single TheraSphere® administration and followed for quality-of-life outcomes and survival for up to 3 years after treatment. Participants will be censored at time of future transplant or if death occurs at any time after treatment.
Study:
NCT07110233
Study Brief:
Protocol Section:
NCT07110233