NCT04923529已完成2 期
Phase II Trial of TAS-102 in Patients With Advanced, Refractory Pancreatic Adenocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- 16-week progression-free survival (PFS) rate
研究概览
简要总结
This is a prospective phase II, single arm clinical trial conducted in Queen Mary Hospital (Hong Kong) assessing the efficacy and safety of TAS-102 in advanced or metastatic pancreatic cancer patients.
详细描述
All the patients must be registered with the Investigator(s) prior to initiation of treatment. The registration desk will confirm all eligibility criteria and obtain essential information (including patient number).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological confirmed advanced or metastatic pancreatic cancer
- •Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of measurable disease
- •Documented progression after one or more lines of systemic chemotherapy
- •For the treatment of advanced or metastatic disease
- •Within 6 months after completion of neo-adjuvant therapy or adjuvant therapy
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance 0-1
- •Written informed consent obtained for clinical trial participation and providing archival tumor tissue, if available
- •Females of childbearing potential or non-sterilized male who are sexually active must use a highly effective method of contraception
- •Females of childbearing potential must have negative serum or urine pregnancy test
- •Have life expectancy ≥ 3 months
- •Adequate organ function as defined as:
- •Hemoglobin value of ≥9.0 g/dL.
- •Absolute neutrophil count of ≥1,500/mm3 (IU: ≥1.5 × 10^9/L).
- •Platelet count ≥100,000/mm3 (IU: ≥100 × 10^9/L).
- •Total serum bilirubin of ≤1.5 mg/dL (except for Grade 1 hyperbilirubinemia due solely to a medical diagnosis of Gilbert's syndrome).
- •Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤3.0 × upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastasis, AST and ALT ≤5 × ULN.
- •Serum creatinine of ≤1.5 mg/dL
排除标准
- •Has disease that is suitable for local therapy administrated with curative intent
- •Has a serious illness or medical condition(s) including, but not limited to the following:
- •Other concurrently active malignancies excluding malignancies that are disease free for more than 5 years or carcinoma-in-situ deemed cured by adequate treatment.
- •Known brain metastasis or leptomeningeal metastasis.
- •Active infection (i.e. body temperature ≥38°C due to infection).
- •Ascites, pleural effusion or pericardial fluid requiring drainage in last 4 weeks.
- •Intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or cerebrovascular disorder.
- •Uncontrolled diabetes.
- •Myocardial infarction within the last 12 months, severe/unstable angina, symptomatic congestive heart failure New York Heart Association (NYHA) class III or IV
- •Gastrointestinal hemorrhage.
- •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, or hepatitis B or C.
- •Patients with autoimmune disorders or history of organ transplantation who require immunosuppressive therapy.
- •Psychiatric disease that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results.
- •Has had treatment with any of the following within the specified time frame prior to study drug administration:
- •Major surgery within prior 4 weeks.
- •Any systemic therapy within prior 2 weeks.
- •Any radiation within prior 2 weeks.
- •Any investigational agent received within prior 4 weeks.
- •Untreated active hepatitis B or hepatitis C infections.
- •Has received TAS-
- •Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies (excluding anemia, alopecia, skin pigmentation and platinum-induced neurotoxicity).
- •Is a pregnant or lactating female.
- •Is inappropriate for entry into this study in the judgment of the Investigator.
研究组 & 干预措施
TAS-102
Experimental
Single group assignment of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma
干预措施: TAS 102 (Drug)
结局指标
主要结局
16-week progression-free survival (PFS) rate
时间窗: From the date of informed consent to radiographically documented progression according to RECIST 1.1, assessed up to 16 weeks
The percentage of study population alive and without progression (according to RECIST 1.1) at 16 weeks from the date of informed consent
次要结局
- Time to progression (TTP)(from the date of informed consent to radiographically documented progression according to RECIST 1.1, assessed up to 3 years)
- Disease control rate (DCR)(from the date of first study treatment to radiographically documented complete response, partial response, or stable disease according to RECIST 1.1, assessed up to 3 years)
- Time to deterioration of ECOG performance status(from the date of informed consent to the first date on which ECOG performance status scores 2 or higher, assessed up to 3 years)
- Progression-free Survival (PFS)(from the date of informed consent to radiographically documented progression according to RECIST 1.1 or death from any cause, whichever occurs first, assessed up to 3 years)
- Incidence of Study-Related Adverse Events [Safety and Tolerability](from the date of first study treatment to occurrence of study-related adverse events based on NCI-CTCAE 5, assessed up to 3 years)
- Overall survival (OS)(from the date of informed consent to the date of death from any cause, assessed up to 5 years)
- Objective response rate (ORR)(From the date of first study treatment to radiographically documented complete response or partial response according to RECIST 1.1, assessed up to 3 years)
- Duration of response (DoR)(from the date of documentation of tumor response to radiographically documented progression according to RECIST 1.1, assessed up to 3 years)
- Time to deterioration of quality of life(from the date of informed consent to recorded decrease of 10 points or more in EORTC QLQ-C30 assessment, assessed up to 3 years)
研究者
Dr. Chi-Leung Chiang
Clinical Assistant Professor
The University of Hong Kong
研究点 (1)
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