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

NCT ID: NCT04233840

Last Updated: 2022-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-12
• Study Completion Date: 2023-07-31

Brief 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.

Detailed Description

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

Conditions

Hepatocellular Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

P1101 (Ropeginterferon alfa-2b)

Intervention Type: DRUG

solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks

Nivolumab

Intervention Type: 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

anti-PD1

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

Group Type: ACTIVE_COMPARATOR

Nivolumab

Intervention Type: 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

P1101 monotherapy

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

Group Type: ACTIVE_COMPARATOR

P1101 (Ropeginterferon alfa-2b)

Intervention Type: DRUG

solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks

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)

Group Type: EXPERIMENTAL

P1101 (Ropeginterferon alfa-2b)

Intervention Type: DRUG

solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks

Nivolumab

Intervention Type: 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

Interventions

P1101 (Ropeginterferon alfa-2b)

solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks

Intervention Type: DRUG

Nivolumab

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

Intervention Type: DRUG

Other Intervention Names

Opdivo

Eligibility 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;

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PharmaEssentia

INDUSTRY

Sponsor Role: collaborator

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pei-Jer Chen

Role: PRINCIPAL_INVESTIGATOR

NTUH

Locations

National Taiwan university Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Pei-Jer Chen

Role: CONTACT

peijerchen@ntu.edu.tw

886-2-23123456 ext. 67072

Shu-Fen Chang

Role: CONTACT

booksun1013@gmail.com

886-2-23819903

Facility Contacts

Pei-Jer Chen

Role: primary

peijerchen@ntu.edu.tw

886-2-23123456 ext. 67072

Shu-Fen Chang

Role: backup

booksun1013@gmail.com

886-2-23819903

Other Identifiers

201710061MIPB

Identifier Type: -

Identifier Source: org_study_id