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| Name | Class |
|---|---|
| PharmaEssentia | INDUSTRY |
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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.
secondary end-point: P1101 and anti-PD1 sequential therapy on hepatitis B (especially on HbsAg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| anti-PD1 | Active Comparator | Phase II Study Group I: anti-PD1 arm 3mg/kg 3 doses |
|
| P1101 monotherapy | Active Comparator | Phase II Study Group II: P1101 arm 450mcg 12 doses |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| P1101 (Ropeginterferon alfa-2b) | Drug | solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 48 weeks |
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Inclusion Criteria:
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;
Normal fundoscopic examination by ophthalmologist at screening;
ECOG 0 to 1 ;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pei-Jer Chen | Contact | 886-2-23123456 | 67072 | peijerchen@ntu.edu.tw |
| Shu-Fen Chang | Contact | 886-2-23819903 | booksun1013@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pei-Jer Chen | NTUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan university Hospital | Recruiting | Taipei | 100 | Taiwan |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Phase I : Dose escalation study with Anti-PD1 dossages 4 cohorts Phase II : 3 parallel arms
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| Nivolumab | 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 |
|
|
| 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 | 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 | 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 |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |