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

Sponsor
National Taiwan University Hospital
Study ID
NCT04233840
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • P1101 (Ropeginterferon alfa-2b) — DRUG
    solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks
  • Nivolumab — DRUG
    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

Study Details

The main purpose of this trial is to evaluate the safety of the new adjuvant treatment of curative HCC, or the treatment of long-acting interferon P1101 alone, or the use of long-acting interferon P1101 and subsequent treatment of anti-PD1, and any efficacy in reducing the recurrence rate of patients after surgery.

Key Dates

Start date
Feb 12, 2019
Status verified
Feb 2021
Primary completion
Dec 31, 2022
Completion
Jul 31, 2023

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Sequential administration of P1101 and anti-PD1
    Phase I of Study : To determine the safety, tolerability, DLT, and potential phase 2 dose of sequential administration of P1101 and anti-PD1 :Sequential administration 6 doses (450mcg) of P1101 and 3 doses of anti-PD1 (Escalating from 0.3, 0.75, 1.5, 3 mg/kg) for Phase I Study
  • Active Comparator: anti-PD1
    Phase II Study Group I: anti-PD1 arm 3mg/kg 3 doses
  • Active Comparator: P1101 monotherapy
    Phase II Study Group II: P1101 arm 450mcg 12 doses
  • Experimental: sequential administration of P1101 and anti-PD1
    Phase II Study GroupIII:Sequential administration of 6 doses of 450mcg P1101 and followed by 3 doses of anti-PD1 dosage (base on Phase I study result)

Primary Outcome Measure

Phase I portion - Dose-limiting Toxicity [ Time Frame: 18 weeks ]

Central Contacts

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