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

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;