NCT04217096Unknown4 期
A Single-arm, Prospective Study to Evaluate the Efficacy and Safety of the Combination of Paclitaxel Liposome and S-1 as First-line Therapy in Treating Patients With Advanced Metastatic Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The present study is intended to investigate the efficacy and safety of the patients with confirmed advanced pancreatic cancer after treating with the combination of paclitaxel liposome plus S-1.
详细描述
Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Masking: Open Lable Primary Purpose: Treatment
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years and ≤75 years;
- •the patients were confirmed as locally advanced or metastatic pancreatic cancer by histopathology;
- •At least one measurable objective lesion was identified based on the RECIST1.1 criteria;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •The expected survival after surgery ≥3 months;
- •Adequate liver/kidney/bone marrow function： Absolute neutrophil count (ANC) ≥1.5×10^9/L; Hemoglobin (Hgb) ≥9g/dL; Platelets (PLT) ≥100×10^9/L; Total bilirubin (TBIL) ≤1.5×ULN; Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/ alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤2.5×institutional upper limit of normal (ULN), or ≤5×ULN(hepatic metastases); Serum creatinine level is normal or creatinine clearance rate≥60 mL/min/1.73 m^
- •Subjects of child-bearing age must agree to take effective contraceptive measures during the study period; Serum or urine pregnancy tests must be negative for women of childbearing age 7 days before the start of chemotherapy、during the monthly treatment interval and after the last treatment;
- •Signed informed content obtained prior to treatment.
排除标准
- •Symptomatic ascites;
- •The target disease has cerebral metastasis;
- •Previously received palliative chemotherapy or other palliative systemic therapy for advanced/metastatic pancreatic cancer;
- •Previously received treatments based on paclitaxel liposomes or S-1, except for neoadjuvant therapy or adjuvant therapy (before and after R0/R1 excision), which was based on paclitaxel liposomes or S-1(the time of discontinuation of neoadjuvant/adjuvant chemotherapy before admission ≥6 months);
- •Received surgical treatment ≤4 weeks before admission;
- •Severe cancer-related cachexia and/or known weight loss >15% occurred within one month before admission;
- •The medical history and complications, which may affect patients' ability to participate in the study and their safety during the study, or interfere with explanation of the study results, for example: uncontrolled hypertension, cardiovascular and cerebrovascular diseases such as cerebrovascular accident (≤6 months from the start of the study), myocardial infarction (≤less than 6 months from the start of the study), unstable angina pectoris, heart failure (≥2 grades) (NYHA functional score), severe arrhythmia requiring medication, metabolic dysfunction, severe renal insufficiency;
- •Human immunodeficiency virus (HIV) or Hepatitis B Virus（HBV）、hepatitis C virus (HCV) positive with Liver dysfunction;
- •Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of admission, excepted cured carcinoma in situ of cervix、basal cell carcinoma of the skin;
- •History of allergy or hypersensitivity to any therapeutic ingredient;
- •Patients with known active alcohol or drug abuse or dependence;
- •Pregnancy, or women who are currently trying to conceive, or who are likely to have children and do not use contraceptives, or breastfeeding women;
- •Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
研究组 & 干预措施
paclitaxel liposome + S-1
Experimental
paclitaxel liposome at 175 mg/m^2 on day 1; S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid，d1-14，q3w）
干预措施: Paclitaxel liposome (Drug)
paclitaxel liposome + S-1
Experimental
paclitaxel liposome at 175 mg/m^2 on day 1; S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid，d1-14，q3w）
干预措施: S-1 (Drug)
结局指标
主要结局
Progression free survival
时间窗: from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months
To evaluate the Progression Free Survival of patients with advanced pancreatic cancer after treated with paclitaxel liposome plus S-1.
次要结局
- Overall Response Rate(from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months)
- overall survival(from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months)
- Disease control rate(from the date of enrollment to the day of progression or death of any cause, whichever come first, assessed up to 10 months)
- Quality of life (Qol)(from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months)
- Adverse events(from the date of enrollmen to death of any cause or the end of this trial, whichever come first, assessed up to 10 months)
研究者
Xian-Jun Yu
Principal Investigator
Fudan University
研究点 (1)
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