A Single-arm, Prospective Study to Evaluate the Safety and Efficacy and of the Combination of Raltitrexed for Injection and Nab-Paclitaxel as Second-line Therapy in Treating Patients With Advanced Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- objective response rate
研究概览
简要总结
The present study is intended to investigate the safety and efficacy of the patients with confirmed advanced pancreatic cancer after treating with the combination of raltitrexed for injection and nab-paclitaxel.
详细描述
Conditions: Advanced pancreatic cancer subjects which were prospectively to receive first-line chemotherapy.
Keywords: Advanced pancreatic cancer; paclitaxel liposome; S-1 Interventions: Drug: paclitaxel liposome; Drug:S-1 Phase: Phase IV Study Type: Interventional
Study Design:
Allocation: Non-randomized Endpoint Classification: Efficacy/ Safety Study Intervention Model: single arm Primary Purpose: Treatment MedlinePlus related topics: Cancer, Pancreatic Cancer Drug Information available for: paclitaxel liposome：paclitaxel liposome for injection S-1：Tegafur, Gimeracil and Oteracil Potassium Capsules
Primary Outcome Measures:
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
- •Signed informed content obtained prior to treatment;
- •The patients were confirmed as advanced pancreatic cancer by histopathology or cytology;
- •At least one measurable objective lesion was identified based on the RECIST 1.1 criteria;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •The expected survival after surgery ≥3 months;
- •Subjects had good compliance, were able to undergo treatment and follow-up, and voluntarily followed the relevant regulations of this study;
- •No contraindications to the use of raltitrexed for injection and nab-paclitaxel;
- •Age ≥18 years and ≤75 years;
- •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;
- •Women must be non-lactating.
排除标准
- •The target disease has cerebral metastasis;
- •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: severe cardiovascular and cerebrovascular diseases, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.;
- •Dementia, altered mental state, or any mental illness that prevents understanding or informed consent or questionnaires;
- •History of allergy or hypersensitivity to any therapeutic ingredient;
- •Combined with other malignant tumors excepted pancreatic cancer within the first 5 years of admission, excepted cured basal cell or squamous cell carcinoma of the skin, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery;
- •Subjects with peripheral neuropathy ≥2 according to CTCAE version 5.0;
- •Physical examination or laboratory examination results are abnormal;
- •Hematological dysfunction is defined as: i) absolute neutrophil (ANC) count <1.5 × 109 / L; ii) platelet (PLT) count: <100 × 109 / L; iii) hemoglobin (Hb) level<90g / L;
- •Hepatic abnormalities are defined as: i) total bilirubin (TBil) levels: >1.5 times the upper limit of normal (ULN); ii) aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels >2.5 times the ULN >5 times ULN if liver metastases are present;
- •Definition of renal dysfunction: serum creatinine >1.5 times ULN, or calculated creatinine clearance <50ml / min;
- •Definition of abnormal blood coagulation function: International Normalized Ratio (INR) >1.5 times of ULN, and prothrombin time (PT) or activated partial thromboplastin time (aPTT) >1.5 times of ULN, unless the subject is receiving anti-antibodies Coagulation treatment.
- •Hepatitis B surface antigen positive (HBsAg), and subjects with peripheral blood hepatitis B virus DNA (HBV-DNA) titer ≥1×103 copies / L; if HBsAg is positive, and peripheral blood HBV-DNA <1×103 copy number / L, if the researcher believes that the subject's chronic hepatitis B is in a stable phase and does not increase the risk of the subject, the subject is eligible for selection;
- •Hepatitis C virus (HCV) or human immunodeficiency virus (HIV) positive;
- •Patients who need to combine other anti-tumor drugs;
- •Participation in any trial drug treatment or another interventional clinical trial 30 days before screening period.
- •Other conditions that researchers not think to be suitable for enrollment.
研究组 & 干预措施
raltitrexed for injection + nab-paclitaxel
Patients receive raltitrexed 2mg/m2 (iv, 15min) and nab-paclitaxel at 125 mg/m2 on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.
干预措施: raltitrexed for injection (Drug)
raltitrexed for injection + nab-paclitaxel
Patients receive raltitrexed 2mg/m2 (iv, 15min) and nab-paclitaxel at 125 mg/m2 on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.
干预措施: nab-paclitaxel (Drug)
结局指标
主要结局
objective response rate
时间窗: up to 36 months
To evaluate the objective response rate of patients with advanced pancreatic cancer after treated with raltitrexed for injection plus nab-paclitaxel as second-line therapy.
progression free survival
时间窗: up to 36 months
To evaluate progression free survival of patients with advanced pancreatic cancer after treated with raltitrexed for injection plus nab-paclitaxel as second-line therapy.
次要结局
- overall survival(up to 36 months)
- adverse events(up to 36 months)
研究者
Xian-Jun Yu
Vice President
Fudan University