Clinical Trials List
Protocol NumberP1101.HCC
NCT Number(ClinicalTrials.gov Identfier)NCT04233840
Active
2018-03-31 - 2026-04-20
Phase I/II
Recruiting1
ICD-10C22.0
Liver cell 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
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Trial Applicant
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Sponsor
National Taiwan University Hospital
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Ming-Chih Ho Division of General Surgery
- 曾岱宗 Division of General Internal Medicine
- Chun-Jen Liu Division of General Internal Medicine
- REY-HENG HU Division of General Surgery
- JA-DER LIANG Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Condition/Disease
Hepatocellular Carcinoma
Objectives
Primary Objectives
Phase I portion:
To evaluate and characterize the safety and tolerability profile, and potential phase 2 dose of
sequential administration of P1101 and anti-PD1 in subjects receiving curative surgery of hepatitis B-related HCC.
Phase II portion:
To evaluate safety and the prophylactic effect of anti-PD1 monotherapy, P1101 monotherapy, or
sequential administration of P1101 and anti-PD1 in subjects receiving curative surgery of hepatitis
B-related HCC, with the recurrence-free survival (defined as the time from randomization to HCC
recurrence or death from any cause, whichever occurred first) at 48 weeks after randomization as the
endpoint
Test Drug
P1101
Active Ingredient
Ropeginterferon alfa-2b
Dosage Form
injection
Dosage
500
Endpoints
Primary Endpoint
Phase I portion
To determine the safety, tolerability, DLT, and potential phase 2 dose of sequential administration of
P1101 and anti-PD1
Phase II portion
To evaluate safety and the recurrence-free survival (defined as the time from randomization to HCC
recurrence or death from any cause, whichever occurred first) at 48 weeks after randomization of
anti-PD1 monotherapy, P1101 monotherapy, or sequential administration of P1101 and anti-PD1
therapy arms.
Secondary Endpoints
• To assess the disease-free survival (defined as the time from randomization to HCC recurrence,
death from any cause, or onset of secondary tumor, whichever occurred first) at 48 weeks after
randomization of anti-PD1 monotherapy, P1101 monotherapy, and sequential administration of
P1101 and anti-PD1 treatment arms
• To assess the treatment effect of anti-PD1 monotherapy, P1101 monotherapy, or sequential
administration of P1101 and anti-PD1 in inhibiting the recurrence, using recurrence-free
survival (defined as the time from randomization to HCC recurrence or death from any cause,
whichever occurred first) at 96 weeks after randomization as the endpoint
• To assess the change in mean HBsAg level from baseline at the end of treatment (EOT), 24
weeks and at 48 weeks after randomization
• Pharmacokinetic assessment
Phase I portion
To determine the safety, tolerability, DLT, and potential phase 2 dose of sequential administration of
P1101 and anti-PD1
Phase II portion
To evaluate safety and the recurrence-free survival (defined as the time from randomization to HCC
recurrence or death from any cause, whichever occurred first) at 48 weeks after randomization of
anti-PD1 monotherapy, P1101 monotherapy, or sequential administration of P1101 and anti-PD1
therapy arms.
Secondary Endpoints
• To assess the disease-free survival (defined as the time from randomization to HCC recurrence,
death from any cause, or onset of secondary tumor, whichever occurred first) at 48 weeks after
randomization of anti-PD1 monotherapy, P1101 monotherapy, and sequential administration of
P1101 and anti-PD1 treatment arms
• To assess the treatment effect of anti-PD1 monotherapy, P1101 monotherapy, or sequential
administration of P1101 and anti-PD1 in inhibiting the recurrence, using recurrence-free
survival (defined as the time from randomization to HCC recurrence or death from any cause,
whichever occurred first) at 96 weeks after randomization as the endpoint
• To assess the change in mean HBsAg level from baseline at the end of treatment (EOT), 24
weeks and at 48 weeks after randomization
• Pharmacokinetic assessment
Inclution Criteria
Participant Inclusion Criteria
(1) Subjects with HCC who meet the following criteria:
1) Subjects diagnosed as having typical HCC on dynamic CT, or dynamic MRI (nodule visualized
as a high signal intensity area in the arterial phase and as a relatively low signal intensity area
in the portal or equilibrium phases) performed within 8 weeks (56 days) before surgery, or
subjects who diagnosed HCC by pathology after surgery resection, either one can be enrolled
in the study.
2) Subjects with the primary occurrence HCC
3) Subjects with the HCC related to hepatitis B virus (HBV)
(2) Subjects who have undergone surgical liver resection within 8 weeks prior to study entry
(3) Subjects showing a complete cure, confirmed by the dynamic CT/MRI image taken in the
screening period, or pathological findings, which shows no findings suggestive of recurrence or
remnant.
(4) Subjects who are able to begin treatment with the study drug within 12 weeks after liver surgery
resection.
(5) Subjects confirmed of satisfying the following conditions based on the screening performed at
enrollment:
1) Positive for HBsAg
2) Undetectable HBV DNA, with or without current anti HBV treatment
3) Grade A on Child-Pugh classification
(6) Normal fundoscopic examination by ophthalmologist at screening; major fundoscopic findings
including but not limited to retinal exudates, hemorrhage, detachment, neovascularization,
papilloedema, optic atrophy, microaneurysms and macular changes
(7) Subjects with ECOG Performance Status score of 0 to 1
(8) Subjects of the age of 20 years and older at the time of informed consent
(9) Subjects who can understand and consent for the content before enrolling in the study
(1) Subjects with HCC who meet the following criteria:
1) Subjects diagnosed as having typical HCC on dynamic CT, or dynamic MRI (nodule visualized
as a high signal intensity area in the arterial phase and as a relatively low signal intensity area
in the portal or equilibrium phases) performed within 8 weeks (56 days) before surgery, or
subjects who diagnosed HCC by pathology after surgery resection, either one can be enrolled
in the study.
2) Subjects with the primary occurrence HCC
3) Subjects with the HCC related to hepatitis B virus (HBV)
(2) Subjects who have undergone surgical liver resection within 8 weeks prior to study entry
(3) Subjects showing a complete cure, confirmed by the dynamic CT/MRI image taken in the
screening period, or pathological findings, which shows no findings suggestive of recurrence or
remnant.
(4) Subjects who are able to begin treatment with the study drug within 12 weeks after liver surgery
resection.
(5) Subjects confirmed of satisfying the following conditions based on the screening performed at
enrollment:
1) Positive for HBsAg
2) Undetectable HBV DNA, with or without current anti HBV treatment
3) Grade A on Child-Pugh classification
(6) Normal fundoscopic examination by ophthalmologist at screening; major fundoscopic findings
including but not limited to retinal exudates, hemorrhage, detachment, neovascularization,
papilloedema, optic atrophy, microaneurysms and macular changes
(7) Subjects with ECOG Performance Status score of 0 to 1
(8) Subjects of the age of 20 years and older at the time of informed consent
(9) Subjects who can understand and consent for the content before enrolling in the study
Exclusion Criteria
Participant Exclusion Criteria
(1) Subjects positive for anti-HCV
(2) Subjects with the HCC related to viral hepatitis other than hepatitis B, non-viral hepatitis,
alcoholic liver disease, nonalcoholic steatohepatitis (NASH) and others
(3) Subjects showing vascular invasion of HCC on imaging diagnosis
(4) Subjects who have also undergone transcatheter arterial embolization or chemoembolization
(TAE/TACE), transcatheter arterial infusion (TAI), or chemolipiodolization in combination with
surgery
(5) Subjects who have received any other investigational drugs, anticancer drugs, or other interferons
after surgery
(6) Subjects who have uncontrolled hypertension with adequate medication, defined as systolic blood
pressure higher or equal to 160 mmHg or diastolic blood pressure higher or equal to 100 mmHg
at screening
(7) Subjects who have a history of allergy to CT contrast media, and whose participation in this study
is judged to be inappropriate by the investigator
(8) Subjects previously had a severe hypersensitivity reaction to treatment with another monoclonal
antibody
(9) Subjects with a history of pneumonitis or interstitial lung disease
(10) Subjects with an active autoimmune disease, a documented history of autoimmune disease or
syndrome, or asthma that requires systemic steroids or immunosuppressive agents
(11) Subjects with CTCAE grade 3 cardiac disease
(12) Subjects with a history of cardiac arrest
(13) Subjects with an active infection requiring therapy
(14) Subjects with poorly controlled major psychiatric disorders, including, but not limited to, severe
depression, severe bipolar disorder, schizophrenia, suicidal ideation, or history of suicidal
attempt
(15) Subjects with any of the following laboratory test or complications
1) Creatinine > l.5 X Upper Limit of Normal (ULN)
2) Absolute neutrophil count (ANC) < 1,500/µL
3) Platelet count < 100,000/µL
4) Hemoglobin < 10 g/dL
5) AST or ALT > 3 X ULN, or total bilirubin > 1.5 X ULN
6) INR or aPTT > 1.5 X ULN
7) Diabetes mellitus with HbA1c ≥ 7.4% with insulin treatment
8) Positive for human immunodeficiency virus (HIV)
(16) Subject has a concurrent active malignancy other than HCC. A subject with previous history of
malignancy is eligible, provided that has been disease free for > 5 years (except for subjects who
were adequately treated with resection for carcinoma in situ or subjects with endoscopically
resection for carcinoma in situ)
(17) Subjects who are pregnant, who have a possibility of being pregnant or who desire to become
pregnant during the study period
(18) Lactating women
(19) Subjects who participated in other clinical trials within the past 6 months
(20) Subjects who are deemed inappropriate to participate in the study by the investigator’s judgment
(1) Subjects positive for anti-HCV
(2) Subjects with the HCC related to viral hepatitis other than hepatitis B, non-viral hepatitis,
alcoholic liver disease, nonalcoholic steatohepatitis (NASH) and others
(3) Subjects showing vascular invasion of HCC on imaging diagnosis
(4) Subjects who have also undergone transcatheter arterial embolization or chemoembolization
(TAE/TACE), transcatheter arterial infusion (TAI), or chemolipiodolization in combination with
surgery
(5) Subjects who have received any other investigational drugs, anticancer drugs, or other interferons
after surgery
(6) Subjects who have uncontrolled hypertension with adequate medication, defined as systolic blood
pressure higher or equal to 160 mmHg or diastolic blood pressure higher or equal to 100 mmHg
at screening
(7) Subjects who have a history of allergy to CT contrast media, and whose participation in this study
is judged to be inappropriate by the investigator
(8) Subjects previously had a severe hypersensitivity reaction to treatment with another monoclonal
antibody
(9) Subjects with a history of pneumonitis or interstitial lung disease
(10) Subjects with an active autoimmune disease, a documented history of autoimmune disease or
syndrome, or asthma that requires systemic steroids or immunosuppressive agents
(11) Subjects with CTCAE grade 3 cardiac disease
(12) Subjects with a history of cardiac arrest
(13) Subjects with an active infection requiring therapy
(14) Subjects with poorly controlled major psychiatric disorders, including, but not limited to, severe
depression, severe bipolar disorder, schizophrenia, suicidal ideation, or history of suicidal
attempt
(15) Subjects with any of the following laboratory test or complications
1) Creatinine > l.5 X Upper Limit of Normal (ULN)
2) Absolute neutrophil count (ANC) < 1,500/µL
3) Platelet count < 100,000/µL
4) Hemoglobin < 10 g/dL
5) AST or ALT > 3 X ULN, or total bilirubin > 1.5 X ULN
6) INR or aPTT > 1.5 X ULN
7) Diabetes mellitus with HbA1c ≥ 7.4% with insulin treatment
8) Positive for human immunodeficiency virus (HIV)
(16) Subject has a concurrent active malignancy other than HCC. A subject with previous history of
malignancy is eligible, provided that has been disease free for > 5 years (except for subjects who
were adequately treated with resection for carcinoma in situ or subjects with endoscopically
resection for carcinoma in situ)
(17) Subjects who are pregnant, who have a possibility of being pregnant or who desire to become
pregnant during the study period
(18) Lactating women
(19) Subjects who participated in other clinical trials within the past 6 months
(20) Subjects who are deemed inappropriate to participate in the study by the investigator’s judgment
The Estimated Number of Participants
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Taiwan
84 participants
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Global
84 participants
