Proton Radiotherapy Plus Tremelimumab/Durvalumab for BCLC Stage B and C HCC

PHASE2RecruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 22, 2025

Primary Completion Date

May 31, 2030

Study Completion Date

May 31, 2033

Conditions
HCC - Hepatocellular CarcinomaDurvalumabTremelimumabProton Radiotherapy
Interventions
RADIATION

Proton radiotherapy

"* 72.6 CGE in 22 fractions for tumors ≤1 cm from the hepatic hilum, bowel, and heart.~* 66 CGE in 10 fractions for tumors \>1 cm from the hepatic hilum, bowel, and heart."

DRUG

Tremelimumab

Tremelimumab 300 mg will be administered as an IV infusion for one dose

DRUG

Durvalumab

"Durvalumab 1500 mg will be administered as an IV infusion every 4 weeks.~Treatment Duration Guidelines:~* Complete Response (CR): Patients who achieve a CR within one year of treatment will continue durvalumab for a total duration of two years.~* Partial Response (PR): Patients who achieve a PR should continue durvalumab until achieving CR, disease progression (PD), or for a total duration of two years.~* Stable Disease (SD): Patients with SD will receive duvalumab for a total of 6 doses."

Trial Locations (1)

333

RECRUITING

Chang Gung Memorial Hospital at Linkou, Taoyuan

All Listed Sponsors
lead

Chang Gung Memorial Hospital

OTHER