Clinical trial NCT04233840: P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: P1101
Anti-PD1
HCC
Hepatocellular Carcinoma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: PharmaEssentia
First posted: 2020-01-18
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase I : Dose escalation study with Anti-PD1 dossages 4 cohorts Phase II : 3 parallel arms
Primary purpose: TREATMENT

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).

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;

Primary outcomes:
measure: Phase I portion - Dose-limiting Toxicity
timeFrame: 18 weeks
measure: Phase II portion - Recurrence-free survival (defined as the time from randomization to HCC recurrence or death from any cause, whichever occured first)
timeFrame: 48 weeks
Secondary outcomes:
measure: Disease-free survival
timeFrame: 48 weeks
measure: Recurrence-free survival
timeFrame: 96 weeks
measure: HBsAg level
timeFrame: 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
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: National Taiwan university Hospital
Study officials:
affiliation: NTUH
name: Pei-Jer Chen
role: PRINCIPAL_INVESTIGATOR
References: