NCT07831330尚未招募2 期
Albumin-bound Paclitaxel (II) in Combination With Gemcitabine as First Line Therapy for Metastatic Pancreatic Cancer: A Multicenter, Single-Arm Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 59
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
This is a prospective, multicenter, open-label, single-arm study in participants with metastatic pancreatic adenocarcinoma who have not received any prior systemic anti-tumor therapy for advanced disease. To evaluate the efficacy and safety of albumin-bound paclitaxel (II) combined with gemcitabine for first-line treatment of metastatic pancreatic cancer.
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
- •1.Age 18-75 years; 2.Histopathologically or cytologically confirmed metastatic pancreatic adenocarcinoma ; 3.No prior systemic anti-tumor therapy (neoadjuvant/adjuvant chemotherapy is permitted, provided that the interval between completion of treatment and initiation of study treatment is >6 months); 4.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 5.ECOG performance status 0-2; 6.Expected survival time ≥ 3 months; 7.Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L, platelet count (PLT) ≥ 100×10⁹/L, hemoglobin (Hb) ≥ 90 g/L; 8.Hepatic function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN (if liver metastases are present, ≤ 5×ULN is permitted); total bilirubin ≤ 1.5×ULN; 9.Renal function: Serum creatinine (Cr) ≤ 1.5×ULN or creatinine clearance ≥ 60 mL/min (calculated by the Cockcroft-Gault formula); 10.Coagulation function: Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN; 11.Ability to understand the study, and voluntary participation with signed informed consent.
排除标准
- •1.Participants with a history of other malignancies within the past 5 years (with the exception of cured basal cell carcinoma or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or other cancers that have been adequately treated and considered cured); 2.Known allergy or intolerance to the study drug or its excipients; 3.Participation in any investigational drug or device therapy within 30 days prior to the first dose of study drug.
- •4.Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy, defined as persistent signs/symptoms related to infection that have not improved despite appropriate antibiotics, antiviral therapy, and/or other treatments.
- •5.Known active HIV infection (i.e., HIV1/2 antibody positive); untreated active HBV infection (defined as HBsAg/HBcAg positive with HBV-DNA copy number above the upper limit of normal at the local laboratory) and HCV infection (HCV antibody positive with HCV-RNA level above the upper limit of normal); 6.There was uncontrolled systemic disease within 6 months before the first administration, including cardiovascular diseases such as unstable angina, myocardial infarction, chronic congestive heart failure of Class II or above (NYHA criteria), severe unstable ventricular arrhythmia, and history of severe pericardial disease; uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite standard antihypertensive therapy), or history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L); gastrointestinal diseases of significant clinical importance, including gastrointestinal obstruction, gastrointestinal perforation, intra-abdominal abscess/infection, etc.; 7.Severe venous thromboembolic events, including deep vein thrombosis and pulmonary embolism, within 3 months prior to enrollment.
- •8.Uncontrolled pleural effusion, ascites, or pericardial effusion. 9.Peripheral sensory neuropathy or peripheral motor neuropathy of grade ≥2 (according to CTCAE V6.0).
- •10.Symptomatic brain metastases, leptomeningeal metastases, spinal cord tumor involvement, or spinal cord compression.
- •11.Pregnant or lactating women, and patients of childbearing potential who refuse to take appropriate contraceptive measures during the trial.
- •12.Patients judged by the investigator to be unsuitable for participation in this study.
研究组 & 干预措施
investigational arm
Experimental
干预措施: Albumin-bound Paclitaxel (Ⅱ) + Gemcitabine (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: Every 8 weeks from time of first dose of study drug until completion of treatment for approximately 6 months.
次要结局
- Disease Control Rate (DCR)(Every 8 weeks from time of first dose of study drug until completion of treatment for approximately 6 months.)
- Progression-Free Survival (PFS)(The median time from first dose administration to tumor progression (per RECIST v1.1) or death in trial participants is expected to be 6 months.)
- Overall Survival (OS)(Overall survival (OS), defined as the time from first dose administration to death from any cause, is estimated to be 13 months in trial participants.)
研究者
Kuirong Jiang
Professor
The First Affiliated Hospital with Nanjing Medical University
相似试验
招募中
2 期
Phase II Trial of Albumin-Bound Paclitaxel Combined With Nedaplatin (TP) Via Hepatic Arterial Infusion for Advanced Breast Cancer Patients With Liver Metastases After Failure of Standard TherapyNCT07284836Zhejiang Cancer Hospital30
招募中
2 期
A Phase II/III Study of F520 Combined With Paclitaxel Plus Carboplatin in the Treatment of Cancer of Unknown Primary (CUP)Cancer of Unknown Primary SiteNCT07761429Shandong New Time Pharmaceutical Co., LTD402
招募中
2 期
Phase II Study of Weekly Paclitaxel/Nab-Paclitaxel, Pembrolizumab, and Mirabegron for Recurrent Ovarian CancerOvarian CancerNCT07261683Obstetrics & Gynecology Hospital of Fudan University20
招募中
3 期
Assessment of prolongation of life with 2 different chemotherapy regimens - Gemcitabine – Cisplatin – Nab-Paclitaxel (GAP) and gemcitabine-platinum (GP) combination in advanced gallbladder cancers.CTRI/2024/01/061479Tata Memorial Centre255
尚未招募
2 期
Lurbinectedin Plus Paclitaxel Versus Paclitaxel in Patients With Previously Treated Small Cell Lung CancerNCT07640932Yonsei University69