Hepatocellular CarcinomaPhase 1/2NCT04233840
P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma
A Phase 1/2 study testing P1101 (Ropeginterferon alfa-2b) and Nivolumab in people with Hepatocellular Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- P1101 (Ropeginterferon alfa-2b) and Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Feb 2019to 31 Jul 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject with HCC who meet the following criteria
- 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;
- Subjects with the primary occurrence HCC ;
- 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. ;
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- 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 ;
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan university Hospital
Taipei, 100
Pei-Jer Chen, 886-2-23123456 ext. 67072, peijerchen@ntu.edu.tw
Shu-Fen Chang, 886-2-23819903, booksun1013@gmail.com
About this study
Official title: 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.
Read the detailed description
secondary end-point: P1101 and anti-PD1 sequential therapy on hepatitis B (especially on HbsAg).
- Conditions
- Hepatocellular Carcinoma
- Being tested
- P1101 (Ropeginterferon alfa-2b), Nivolumab
- Keywords
- P1101, Anti-PD1, HCC, Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1101 (Ropeginterferon alfa-2b)Drug
solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks
NivolumabDrug
Also called Opdivo
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
| Study group | Role | What they receive |
|---|---|---|
| Sequential administration of P1101 and anti-PD1 | Experimental | 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 Receives: Drug: P1101 (Ropeginterferon alfa-2b); Drug: Nivolumab |
| anti-PD1 | Active comparator | Phase II Study Group I: anti-PD1 arm 3mg/kg 3 doses Receives: Drug: Nivolumab |
| P1101 monotherapy | Active comparator | Phase II Study Group II: P1101 arm 450mcg 12 doses Receives: Drug: P1101 (Ropeginterferon alfa-2b) |
| sequential administration of P1101 and anti-PD1 | Experimental | 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) Receives: Drug: P1101 (Ropeginterferon alfa-2b); Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I portion - Dose-limiting Toxicity
To determine the potential phase 2 dose of sequestial administration of P1101 and anti-PD1. The MTD is determine by the prior dose level below the dose level at which ≥2/3 or ≥2/6 subjects suffer dose-limiting toxicity (DLT).
Measured: 18 weeks
Phase II portion - Recurrence-free survival (defined as the time from randomization to HCC recurrence or death from any cause, whichever occured first)
To evaluate safety(assessment of AE, SAE and unanticipated problem) and the recurrence-free survival (defined as the time from randomization to HCC recurrence or death from any cause, whichever occured first) at 48 weeks after randomization of anti-PD 1 monotherapy, P1101 monotherapy, and sequential administration of P1101 and anti-PD 1 therapy arms
Measured: 48 weeks
Secondary outcomes (3)
Disease-free survival
To assess the effect of anti-PD1 monotherapy, P1101 monotherapy, and sequential administration of P1101 and anti-PD1 in inhibiting the recurrence, using 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 as the endpoint
Measured: 48 weeks
Recurrence-free survival
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
Measured: 96 weeks
HBsAg level
To assess the change in mean HBsAg level from baseline at the end of treatment (EOT), 24 weeks and 48 weeks after randomization
Measured: End of treatment of Anti-PD1 arm is up to 6 weeks; End of treatment of P1101 arm is up to 24 weeks; End of treatment of sequential administration of P1101 and anti-PD1 is up to 18 weeks, 24 weeks and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start12 Feb 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase I : Dose escalation study with Anti-PD1 dossages 4 cohorts Phase II : 3 parallel arms
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaEssentia
- Responsible party
- Sponsor
- Investigators
- Pei-Jer Chen, Principal investigator, NTUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233840
- Sponsor's protocol ID
- 201710061MIPB
- Status last verified
- Feb 2021
- First submitted
- 26 Dec 2019
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04233840
- Acronym / sponsor ID
- 201710061MIPB
- Conditions
- Hepatocellular Carcinoma
- Keywords
- P1101, Anti-PD1, HCC, Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- PharmaEssentia
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase I : Dose escalation study with Anti-PD1 dossages 4 cohorts Phase II : 3 parallel arms
| Arm | Type | Receives |
|---|---|---|
| Sequential administration of P1101 and anti-PD1 | Experimental | Drug: P1101 (Ropeginterferon alfa-2b), Drug: NivolumabPhase 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 |
| anti-PD1 | Active comparator | Drug: NivolumabPhase II Study Group I: anti-PD1 arm 3mg/kg 3 doses |
| P1101 monotherapy | Active comparator | Drug: P1101 (Ropeginterferon alfa-2b)Phase II Study Group II: P1101 arm 450mcg 12 doses |
| sequential administration of P1101 and anti-PD1 | Experimental | Drug: P1101 (Ropeginterferon alfa-2b), Drug: NivolumabPhase 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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject with HCC who meet the following criteria
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P1101 (Ropeginterferon alfa-2b)solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks | Drug | P1101 monotherapy, Sequential administration of P1101 and anti-PD1, sequential administration of P1101 and anti-PD1 |
| NivolumabAlso: OpdivoPhase 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 | Drug | Sequential administration of P1101 and anti-PD1, anti-PD1, sequential administration of P1101 and anti-PD1 |
Primary outcome
Phase I portion - Dose-limiting Toxicity
Time frame: 18 weeks
To determine the potential phase 2 dose of sequestial administration of P1101 and anti-PD1. The MTD is determine by the prior dose level below the dose level at which ≥2/3 or ≥2/6 subjects suffer dose-limiting toxicity (DLT).
Phase II portion - Recurrence-free survival (defined as the time from randomization to HCC recurrence or death from any cause, whichever occured first)
Time frame: 48 weeks
To evaluate safety(assessment of AE, SAE and unanticipated problem) and the recurrence-free survival (defined as the time from randomization to HCC recurrence or death from any cause, whichever occured first) at 48 weeks after randomization of anti-PD 1 monotherapy, P1101 monotherapy, and sequential administration of P1101 and anti-PD 1 therapy arms
3 secondary outcomes
Disease-free survival
Time frame: 48 weeks
Recurrence-free survival
Time frame: 96 weeks
HBsAg level
Time frame: End of treatment of Anti-PD1 arm is up to 6 weeks; End of treatment of P1101 arm is up to 24 weeks; End of treatment of sequential administration of P1101 and anti-PD1 is up to 18 weeks, 24 weeks and 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Jer Chen principal investigator
NTUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing P1101 (Ropeginterferon alfa-2b) and Nivolumab in people with Hepatocellular Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Jer Chen (886-2-23123456 ext. 67072, peijerchen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I portion - Dose-limiting Toxicity (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.