Hepatocellular Carcinoma Clinical Trial
— OASESOfficial title:
A Phase II Study to Assess the Safety and Efficacy of PTS100 in Primary Hepatocellular Carcinoma Patients Who Are Ineligible for Operation or Current Locoregional Therapy
This study is being performed to evaluate the efficacy and safety of 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.
Status | Recruiting |
Enrollment | 33 |
Est. completion date | December 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | 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, or 2. 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: 1. Eastern Cooperative Oncology Group (ECOG) performance status of = 1. 2. 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. |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | Taipei Medical University Hospital | Taipei City | |
Taiwan | Taipei Veterans General Hospital | Taipei City |
Lead Sponsor | Collaborator |
---|---|
Gongwin Biopharm Co., Ltd. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 4-week post treatment | |
Secondary | Local disease control rate (LDCR) | Local disease control rate (LDCR) of pooled treatment groups based on the modified RECIST (mRECIST) criteria at concluding visit. | 4-week post treatment | |
Secondary | Time to treated tumor progression (TTTTP) | Time to treated tumor progression (TTTTP) of pooled treatment groups | 4-week post treatment, then every 2 months follow up with imaging will be continued for 12 months | |
Secondary | Three-year overall survival (OS) | Three-year overall survival of pooled treatment groups | Time from first IP administration to patient death or to the date of 3 years after first IP administration | |
Secondary | Time to tumor stage progression (TSP) | Time to tumor stage progression of pooled treatment groups | Time from first IP administration to every 2 months follow up with imaging will be continued for 12 months | |
Secondary | Difference in ORR between group 1 and group 2 | Difference in ORR between 20% group and 30% group at concluding visit | 4-week post treatment | |
Secondary | Difference in LDCR between group 1 and group 2 | Difference in LDCR between 20% group and 30% group at concluding visit | 4-week post treatment | |
Secondary | Difference in TTTTP between group 1 and group 2 | Difference in TTTTP between 20% group and 30% group at concluding visit | 4-week post treatment to every 2 months follow up with imaging will be continued for 12 months | |
Secondary | Incidence of Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0 | Enrollment to 4-week post treatment | |
Secondary | 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. | 4-week post treatment and every 2 months follow up will be continued for 12 months | |
Secondary | 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. | 4-week post treatment and every 2 months follow up will be continued for 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04209491 -
Interest of the Intervention of a Nurse Coordinator in Complex Care Pathway
|
||
Completed |
NCT03963206 -
Cabozantinib toLERANCE Study in HepatoCellular Carcinoma (CLERANCE)
|
Phase 4 | |
Completed |
NCT03268499 -
TACE Emulsion Versus Suspension
|
Phase 2 | |
Recruiting |
NCT05044676 -
Immune Cells as a New Biomarker of Response in Patients Treated by Immunotherapy for Advanced Hepatocellular Carcinoma
|
||
Recruiting |
NCT05263830 -
Glypican-3 as a Prognostic Factor in Patients With Hepatocellular Carcinoma Treated by Immunotherapy
|
||
Recruiting |
NCT05095519 -
Hepatocellular Carcinoma Imaging Using PSMA PET/CT
|
Phase 2 | |
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Completed |
NCT05068193 -
A Clinical Trial to Compare the Pharmacokinetics and Bioequivalence of "BR2008" With "BR2008-1" in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT03781934 -
A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations
|
Phase 1/Phase 2 | |
Terminated |
NCT03655613 -
APL-501 or Nivolumab in Combination With APL-101 in Locally Advanced or Metastatic HCC and RCC
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04242199 -
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of INCB099280 in Participants With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT04401800 -
Preliminary Antitumor Activity, Safety and Tolerability of Tislelizumab in Combination With Lenvatinib for Hepatocellular Carcinoma
|
Phase 2 | |
Withdrawn |
NCT05418387 -
A Social Support Intervention to Improve Treatment Among Hispanic Kidney and Liver Cancer Patients in Arizona
|
N/A | |
Active, not recruiting |
NCT04039607 -
A Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Hepatocellular Carcinoma
|
Phase 3 | |
Terminated |
NCT03970616 -
A Study of Tivozanib in Combination With Durvalumab in Subjects With Advanced Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT03642561 -
Evaluation the Treatment Outcome for RFA in Patients With BCLC Stage B HCC in Comparison With TACE
|
Phase 2/Phase 3 | |
Recruiting |
NCT06239155 -
A Phase I/II Study of AST-3424 in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04118114 -
Phase II Study of PRL3-ZUMAB in Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT03222076 -
Nivolumab With or Without Ipilimumab in Treating Patients With Resectable Liver Cancer
|
Phase 2 |