Overview

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

Status:
Recruiting
Trial end date:
2023-07-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Taiwan University Hospital
Collaborator:
PharmaEssentia
Treatments:
Nivolumab
Criteria
Inclusion Criteria:

- Subject with HCC who meet the following criteria

1. Subjects diagnosed as having typical HCC on dynamic CT, or dynamic MRI performed
within 8 weeks before surgery, or subjects who diagnosed HCC by pathology after
surgery resection;

2. Subjects with the primary occurrence HCC ;

3. Subjects with the HCC related to hepatitis B virus (HBV) ;

- Subject who have undergone surgical liver reaction within 8 weeks prior to study
entry.

- Subjects showing a complete cure shows no findings suggestive of recurrence or
remnant. ;

- Subject who are able to begin treatment with the study drug within 12 weeks after
liver surgery resection. ;

- Subjects confirmed of satisfying the following conditions based on the screening
performed at enrollment: Positive for HBsAg/ Undetectable HBV DNA, with or without
current anti HBV treatment/ Grade A on Child-Pugh classification;

- Normal fundoscopic examination by ophthalmologist at screening;

- ECOG 0 to 1 ;

Exclusion Criteria:

- Subjects positive for anti-HCV ;

- Subjects showing vascular invasion of HCC on imaging diagnosis ;

- Subjects who have uncontrolled hypertension;

- Subjects with a history of pneumonitis or interstitial lung disease . cardiac arrest .
an active infection requiring therapy .;

- Diabetes mellitus with HbA1c ≥ 7.4% with insulin treatment;