NCT03447951招募中2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
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.
详细描述
BCLC stage B patients who are ineligible for operational or current locoregional therapy. Enrolled patients are assigned to 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •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/mm
- •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.
排除标准
- •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 PTS
- •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.
研究组 & 干预措施
PTS100 (Para-Toluenesulfonamide): 30%TTV
Experimental
Total dose = 30% total tumor volume
干预措施: Para-Toluenesulfonamide (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 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.
次要结局
- Three-year overall survival (OS)(Time from first IP administration to patient death or to the date of 3 years after first IP administration)
- Time to tumor stage progression (TSP)(Time from first IP administration to every 2 months follow up with imaging will be continued for 12 months)
- Difference in ORR between group 1 and group 2(4-week post treatment)
- Local disease control rate (LDCR)(4-week post treatment)
- Time to treated tumor progression (TTTTP)(4-week post treatment, then every 2 months follow up with imaging will be continued for 12 months)
- Difference in LDCR between group 1 and group 2(4-week post treatment)
- Difference in TTTTP between group 1 and group 2(4-week post treatment to every 2 months follow up with imaging will be continued for 12 months)
- Incidence of Treatment-Emergent Adverse Events(Enrollment to 4-week post treatment)
- FACT-Hep quality of life score(4-week post treatment and every 2 months follow up will be continued for 12 months)
- EQ-5D-5L quality of life score(4-week post treatment and every 2 months follow up will be continued for 12 months)
研究者
研究点 (3)
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