P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

February 12, 2019

Primary Completion Date

December 31, 2022

Study Completion Date

July 31, 2023

Conditions
Hepatocellular Carcinoma
Interventions
DRUG

P1101 (Ropeginterferon alfa-2b)

solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks

DRUG

Nivolumab

"Phase I study will use 0.3, 0.75, 1.5, 3mg/kg, Q2W for 3 doses after 6 doses of P1101.~Phase II study : Group I will use 3mg/kg, Q2W for 3 doses; Group III will use the dosage that determine from Phase I study 3 doses after 6 doses of P1101"

Trial Locations (1)

100

RECRUITING

National Taiwan university Hospital, Taipei

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PharmaEssentia

INDUSTRY

lead

National Taiwan University Hospital

OTHER

NCT04233840 - P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma | Biotech Hunter | Biotech Hunter