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A Phase II Study of PTS100 in Primary HCC Patients (OASES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03447951
Recruitment Status : Recruiting
First Posted : February 27, 2018
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Gongwin Biopharm Co., Ltd.

Brief Summary:
This study is being performed to evaluate the efficacy and safety of 20% and 30% PTS100 of total tumor volume as intra-tumoral injection therapy in primary Hepatocellular Carcinoma patients who are ineligible for operation or local regional therapy.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Para-Toluenesulfonamide Phase 2

Detailed Description:
BCLC stage B patients who are ineligible for operational or current locoregional therapy. Enrolled patients are randomly assigned to either of the two total doses, 20% or 30% of total tumor volume. PTS100 is administrated via intratumoral injection. The required total dose is given in separate injection days, with maximal daily dose up to 10 mL at first IP administration, and is adjusted based on each patient's tolerability along the treatment. The treatment course lasts up to completion of the total dose, and the efficacy is evaluated 28 days afterwards.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Dose-randomization, Open-label Study to Assess the Safety and Efficacy of PTS100 in Primary Hepatocellular Carcinoma Patients Who Are Ineligible for Operation or Current Locoregional Therapy
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2023

Arm Intervention/treatment
Experimental: PTS100 (Para-Toluenesulfonamide): 20%TTV
Group 1: total dose = 20% total tumor volume
Drug: Para-Toluenesulfonamide
A total dose of PTS100 in this study, the expected accumulated dose in the treatment duration, depends on the patient's tumour size. For each patient, up to 4 tumors, each not exceeding 8.8 cm in diameter, are selected for treatment by the joint decision of the investigator and the radiologist. The total dose is defined as the accumulated dose in treatment duration. The total dose is randomly assigned as either 20% or 30% of TTV for each patient and maximum TTV should be less than 366 cm3.
Other Name: PTS100

Experimental: PTS100 (Para-Toluenesulfonamide): 30%TTV
Group 2: total dose = 30% total tumor volume
Drug: Para-Toluenesulfonamide
A total dose of PTS100 in this study, the expected accumulated dose in the treatment duration, depends on the patient's tumour size. For each patient, up to 4 tumors, each not exceeding 8.8 cm in diameter, are selected for treatment by the joint decision of the investigator and the radiologist. The total dose is defined as the accumulated dose in treatment duration. The total dose is randomly assigned as either 20% or 30% of TTV for each patient and maximum TTV should be less than 366 cm3.
Other Name: PTS100




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 4-week post treatment ]
    To evaluate the efficacy, measured by objective response rate (ORR) of pooled treatment groups based on the modified RECIST (mRECIST) criteria at concluding visit.


Secondary Outcome Measures :
  1. Local disease control rate (LDCR) [ Time Frame: 4-week post treatment ]
    Local disease control rate (LDCR) of pooled treatment groups based on the modified RECIST (mRECIST) criteria at concluding visit.

  2. Time to treated tumor progression (TTTTP) [ Time Frame: 4-week post treatment, then every 2 months follow up with imaging will be continued for 12 months ]
    Time to treated tumor progression (TTTTP) of pooled treatment groups

  3. Three-year overall survival (OS) [ Time Frame: Time from first IP administration to patient death or to the date of 3 years after first IP administration ]
    Three-year overall survival of pooled treatment groups

  4. Time to tumor stage progression (TSP) [ Time Frame: Time from first IP administration to every 2 months follow up with imaging will be continued for 12 months ]
    Time to tumor stage progression of pooled treatment groups

  5. Difference in ORR between group 1 and group 2 [ Time Frame: 4-week post treatment ]
    Difference in ORR between 20% group and 30% group at concluding visit

  6. Difference in LDCR between group 1 and group 2 [ Time Frame: 4-week post treatment ]
    Difference in LDCR between 20% group and 30% group at concluding visit

  7. Difference in TTTTP between group 1 and group 2 [ Time Frame: 4-week post treatment to every 2 months follow up with imaging will be continued for 12 months ]
    Difference in TTTTP between 20% group and 30% group at concluding visit

  8. Incidence of Treatment-Emergent Adverse Events [ Time Frame: Enrollment to 4-week post treatment ]
    Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0

  9. FACT-Hep quality of life score [ Time Frame: 4-week post treatment and every 2 months follow up will be continued for 12 months ]
    To evaluate the health-related Quality of life, assessed by change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep, version 4, Traditional Chinese). The FACT-Hep, version 4, Traditional Chinese Scale is a patient completed questionnaire consisting 45 items that assesses health related quality of life (HRQL) in HCC patients. The FACT-Hep, version 4, Traditional Chinese consists of the 27-item FACT-G assessing generic HRQL concerns and 18-item Hepatobiliary Subscale assessing disease-specific issues. Instrument scoring yields a range from 0 to 180 with higher scores representing better patient status. This questionnaire should be completed by patient prior to any procedures being performed at the visit, if possible. The form should then be checked by site staff for completeness.

  10. EQ-5D-5L quality of life score [ Time Frame: 4-week post treatment and every 2 months follow up will be continued for 12 months ]
    To evaluate the health-related Quality of life, assessed by change in EuroQol 5 dimensions 5 level (EQ-5D-5L). It comprises the same 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels. However, this results have no arithmetic properties and should not be used as a cardinal score. This questionnaire should be completed by the patient prior to any procedure being performed at the visit, if possible. The form should then be checked by site staff for completeness.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, ≥ 20 years and ≤ 80 years of age.
  • Patients with clinically confirmed primary HCC following American Association for the Study of Liver Diseases (AASLD, Appendix 1) guidance:

    1. Cyto-histological evidence
    2. Coincident imaging evidence using computerized tomography (CT) or magnetic resonance imaging (MRI)
  • Based on investigator discretion, patients who are ineffective or unsuitable for resection, immediate liver transplantation, Trans Arterial Chemoembolization (TACE), or current local ablative treatment and meet all of the following conditions at study entry:

    1. Barcelona Clinic Liver Cancer (BCLC) stage B.
    2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
    3. Child Pugh score class A or B.
  • Patients with at least one measurable lesion with size ≥ 1 cm.
  • Patients with cumulative total treated tumor volume ≤ 366 cm3 and ≤ 4 target tumors.
  • Patients with adequate bone marrow, liver and renal function within 28 days prior to study entry, as defined by the following:

    1. Hemoglobin > 10.0 g/dl.
    2. Absolute neutrophil count (ANC) > 1,500/mm3.
    3. Platelet count > 80k/mm3 correctable by component therapy.
    4. Albumin ≥ 3 g/dl.
    5. Total bilirubin < 2 mg/dL.
    6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x upper normal limit (UNL).
    7. Blood urea nitrogen (BUN) and serum creatinine < 1.5 x UNL.
    8. International normalized ratio (INR) < 1.5 or prothrombin time (PT) < 15 seconds.
  • Patients with life expectancy > 3 months as judged by investigator.
  • Patients who understand and comply to the study procedure and be willing to provide a written informed consent form.

Exclusion Criteria:

  • Infiltrative HCC or tumor burden ≥ 50% of liver parenchyma.
  • Patients with cumulative total treated tumor volume > 366 cm3 or more than 4 target tumors.
  • Any target tumor exceeds 8.8 cm in diameter.
  • The treated tumor is located in close proximity to another organ (e.g. gall bladder, liver capsule, diaphragm ) or major blood vessel and less than 0.5 cm in distance .
  • Presence of metastasis or vascular invasion.
  • Systemic chemotherapy treatment for HCC within 12 weeks prior to study entry.
  • Major surgery within 4 weeks prior to study entry (e.g. thoracolaparotomy is not allowed, but noninvasive surgery, e.g. biopsy, is allowed).
  • Use of any investigational drugs, biologics, or devices within 4 weeks prior to study entry or planned use during the course of study.
  • Any other severe disease (e.g. active infection, uncontrolled diabetes mellitus, severe heart dysfunction or angina, gastric ulcer, active auto-immune disease) judged by the investigator to limit subject participation in the study.
  • Female subjects who are pregnant or lactating. Women of childbearing potential must have a negative urine pregnancy test performed within seven days prior to the start of study drug and agree to practice medically acceptable contraceptive regimen from screening until at least 28 days after the study treatment. Patients who are postmenopausal for at least 1 year (> 12 months since the last menstrual cycle) or were surgically sterilized do not require the pregnancy test.
  • Known or suspected allergy and/or hypersensitivity to any of the ingredients of PTS100.
  • Any target lesion blocked by bile ducts or important blood vessels, judged by investigator, that is difficult to conduct intratumoral injection.
  • Any condition, judged by investigator, that shows subjects are not suitable for participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03447951


Contacts
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Contact: Chi Chiang Tu +886-2-2503-5282 ext 303 erictu@gongwinbiopharm.com

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Ja Der Liang         
Sponsors and Collaborators
Gongwin Biopharm Co., Ltd.
Investigators
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Principal Investigator: Ja Der Liang National Taiwan University Hospital

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Responsible Party: Gongwin Biopharm Co., Ltd.
ClinicalTrials.gov Identifier: NCT03447951    
Other Study ID Numbers: GW-020202
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases