Clinical Trials List
Protocol NumberGW-020202
NCT Number(ClinicalTrials.gov Identfier)NCT03447951
Active
2017-01-01 - 2028-12-31
Phase II
Recruiting5
Terminated1
ICD-10C22.0
Liver cell carcinoma
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 (OASES)
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Trial Applicant
A2 HEALTHCARE TAIWAN CORPORATION
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Sponsor
Gongwin Biopharm Co., Ltd.
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Trial scale
Taiwan Multiple Center
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Update
2026/08/24
Investigators and Locations
Co-Principal Investigator
- Chien-Hung Chen Digestive System Department
- 吳志宏 Division of Radiology
- 廖思涵 Digestive System Department
- 張智凱 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Rheun-Chuan Lee Division of Radiology
- I-Cheng Lee Digestive System Department
- San-Chi Chen Division of Hematology & Oncology
- Yun-Cheng Hsieh Digestive System Department
- Pei-Chang Lee Digestive System Department
- Chien-An Liu Division of Radiology
The Actual Total Number of Participants Enrolled
0 Recruiting
Audit
None
Co-Principal Investigator
- Chun-Chao Chang Digestive System Department
- 林俊宇 Division of Radiology
- 夏和雄 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 吳峯旭 Division of General Surgery
- 呂宜達 Digestive System Department
- 李少武 Digestive System Department
- 張碧倚 Division of Radiology
- YI-JU CHEN Division of General Surgery
- Sheng-Shun Yang Digestive System Department
- 詹松儒 Division of Radiology
- 蔡炘儒 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Shi-Ming Lin
Co-Principal Investigator
- 呂嘉偉 Division of Radiology
- 陳威廷 Digestive System Department
- Yi-Chung Hsieh Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Hepatocellular Carcinoma
Objectives
To evaluate the efficacy, measured by objective response rate (ORR) of pooled treatment groups based on the modified RECIST (mRECIST) criteria at concluding visit.
Test Drug
Para-Toluenesulfonamide (PTS)
Active Ingredient
Para-Toluenesulfonamide (PTS)
Dosage Form
Injection
Dosage
5 mL per ampoule
Endpoints
Primary Outcome Measures:
Objective Response Rate (ORR):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 :
Local disease control rate (LDCR):Local disease control rate (LDCR) of pooled treatment groups based on the modified RECIST (mRECIST) criteria at concluding visit.
Time to treated tumor progression (TTTTP):Time to treated tumor progression (TTTTP) of pooled treatment groups
Three-year overall survival (OS):Three-year overall survival of pooled treatment groups
Time to tumor stage progression (TSP):Time to tumor stage progression of pooled treatment groups
Difference in ORR between group 1 and group 2:Difference in ORR between 20% group and 30% group at concluding visit
Difference in LDCR between group 1 and group 2:Difference in LDCR between 20% group and 30% group at concluding visit
Difference in TTTTP between group 1 and group 2:Difference in TTTTP between 20% group and 30% group at concluding visit
Incidence of Treatment-Emergent Adverse Events:Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0
FACT-Hep quality of life score: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.
EQ-5D-5L quality of life score: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.
Objective Response Rate (ORR):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 :
Local disease control rate (LDCR):Local disease control rate (LDCR) of pooled treatment groups based on the modified RECIST (mRECIST) criteria at concluding visit.
Time to treated tumor progression (TTTTP):Time to treated tumor progression (TTTTP) of pooled treatment groups
Three-year overall survival (OS):Three-year overall survival of pooled treatment groups
Time to tumor stage progression (TSP):Time to tumor stage progression of pooled treatment groups
Difference in ORR between group 1 and group 2:Difference in ORR between 20% group and 30% group at concluding visit
Difference in LDCR between group 1 and group 2:Difference in LDCR between 20% group and 30% group at concluding visit
Difference in TTTTP between group 1 and group 2:Difference in TTTTP between 20% group and 30% group at concluding visit
Incidence of Treatment-Emergent Adverse Events:Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0
FACT-Hep quality of life score: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.
EQ-5D-5L quality of life score: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.
Inclution 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:
Cyto-histological evidence, or
Coincident imaging evidence using computerized tomography (CT) or magnetic resonance imaging (MRI)
Based on investigator discretion, patients who are diagnosed at Barcelona Clinic Liver Cancer (BCLC) stage B and 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:
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
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:
Hemoglobin > 10.0 g/dl.
Absolute neutrophil count (ANC) > 1,500/mm3.
Platelet count > 80k/mm3 correctable by component therapy.
Albumin ≥ 3 g/dl.
Total bilirubin < 2 mg/dL.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x upper normal limit (UNL).
Blood urea nitrogen (BUN) and serum creatinine < 1.5 x UNL.
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.
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:
Cyto-histological evidence, or
Coincident imaging evidence using computerized tomography (CT) or magnetic resonance imaging (MRI)
Based on investigator discretion, patients who are diagnosed at Barcelona Clinic Liver Cancer (BCLC) stage B and 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:
Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
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:
Hemoglobin > 10.0 g/dl.
Absolute neutrophil count (ANC) > 1,500/mm3.
Platelet count > 80k/mm3 correctable by component therapy.
Albumin ≥ 3 g/dl.
Total bilirubin < 2 mg/dL.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5 x upper normal limit (UNL).
Blood urea nitrogen (BUN) and serum creatinine < 1.5 x UNL.
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
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.
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.
The Estimated Number of Participants
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Taiwan
33 participants
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Global
33 participants
