Immunotherapy Combined with Radiation for Unresectable Hepatocellular Carcinoma

JRCT ID: jRCT1061240087

Registered date:10/12/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatocellular carcinoma
• Date of first enrollment: 10/12/2024
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Radiation therapy will be added for patients who have been induction treated with atezolizumab bevacizumab for hepatocellular carcinoma and who have reached SD/PD status by RECICT v1.1 criteria.

Outcome(s)

• Primary Outcome: Adverse event

Secondary Outcome

(1) Response rate
(2) Progression-free survival
(3) Duration of response

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Persons who are 18 years of age or older at the time of obtaining consent
(2) Male or female
(3) PS 0 or 1
(4) Patients diagnosed with SD or PD based on RECIST ver.1.1 after starting treatment with atezolizumab or bevacizumab
(5) Patients with at least one intrahepatic target lesion based on RECIST ver. 1.1
(6) Patients with no history of systemic drug therapy or radiation therapy for hepatocellular carcinoma
(7) Patients must be confirmed disease-free for at least 6 months after the last administration of postoperative adjuvant drug therapy
(7) Patients with Child Pugh class A
(8) Subjects who have received a thorough explanation of the study and who have given their consent to participate in the study in writing of their own free will after full understanding of the study

Exclude criteria

(1) Patients with hepatocellular carcinoma occupying more than 50% of the liver volume
(2) Patients with allergy to CT/MRI contrast media
(3) Patients with estimated glomerular filtration rate (eGFR) < 30
(4) Patients with active multiple cancers
(5) Other subjects who are judged by the principal investigator and the subinvestigators to be inappropriate as research subjects due to the disease status of the tumor, difficulty in induction of chemotherapy, or other reasons.

Related Information

• Primary Sponsor: Takeuchi Yasuto