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

A Phase I/II Open Label Study to Evaluate Safety and the Prophylactic Effect on Recurrence of Anti-PD1 Monotherapy, P1101 Monotherapy, and Sequential Administration of P1101 and Anti-PD1 After Curative Surgery of HBV-related HCC

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.

secondary end-point: P1101 and anti-PD1 sequential therapy on hepatitis B (especially on HbsAg).

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;