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

Who is this study for? Adults with Hepatocellular Carcinoma
What treatments are being studied? Para-Toluenesulfonamide
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Medical University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Ben Liu
ben.liu@gongwinbiopharm.com
+886-2-2503-5282
Backup
Eric Tu
erictu@gongwinbiopharm.com
+886-2-2503-5282
Time Frame
Start Date: 2018-06-19
Estimated Completion Date: 2025-12
Participants
Target number of participants: 33
Treatments
Experimental: PTS100 (Para-Toluenesulfonamide): 30%TTV
Total dose = 30% total tumor volume
Related Therapeutic Areas
Sponsors
Leads: Gongwin Biopharm Co., Ltd.

This content was sourced from clinicaltrials.gov