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

National Taiwan University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: Nivolumab; Drug: P1101 (Ropeginterferon alfa-2b)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04233840

201710061MIPB

Details and patient eligibility

About

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.

Full description

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

Enrollment: 72 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 4 patient groups

Sequential administration of P1101 and anti-PD1

Experimental group

Description:

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

Treatment:

Drug: Nivolumab

Drug: P1101 (Ropeginterferon alfa-2b)

anti-PD1

Active Comparator group

Description:

Phase II Study Group I: anti-PD1 arm 3mg/kg 3 doses

Treatment:

Drug: Nivolumab

P1101 monotherapy

Active Comparator group

Description:

Phase II Study Group II: P1101 arm 450mcg 12 doses

Treatment:

Drug: P1101 (Ropeginterferon alfa-2b)

sequential administration of P1101 and anti-PD1

Experimental group

Description:

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)

Treatment:

Drug: Nivolumab

Drug: P1101 (Ropeginterferon alfa-2b)