NCT03850769Unknown2 期
Prospective Phase II Single-arm Study of Neoadjuvant Nab-Paclitaxel and S-1 in Patients With Borderline Resectable Pancreatic Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- R0 resection rate
研究概览
简要总结
This study was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. A total of 60 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1, for a maximum of 4 cycles prior to pancreatectomy. The primary endpoint is R0 resection rate, the secondary endpoints include overall survival and response rate.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients have good compliance, can understand the research process of this study, and sign a written informed consent
- •Patients with pathologically confirmed pancreatic adenocarcinoma.
- •Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
- •Patients with borderline resectable pancreatic cancer ( NCCN Version 1，2019 criteria).
- •ECOG PS 0-1;
- •Tumor size is measurable according to RECIST1.1 criteria
- •Expected survival over 3 months;
- •Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
- •Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
- •No contraindications to the use of S-1 and nab-paclitaxel.
排除标准
- •≥ Grade 2 existing peripheral neuropathy;
- •Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
- •Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
- •Severe, active co-morbidity, defined as follows:
- •Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
- •Not able to take medicine orally.
- •Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
- •Participation in other clinical trial within 30 days before the first dose of the drug;
研究组 & 干预措施
nab-paclitaxel and S-1
Experimental
neoadjuvant chemotherapy with Nab-paclitaxel and S-1, repeat every 21 days for 4 cycles.
干预措施: nab-paclitaxel and S-1 (Drug)
结局指标
主要结局
R0 resection rate
时间窗: 3 years
proportion of patients who achieved R0 resection
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Multicentre, two-stage, phase 2 study of neoadjuvant FOLFIRINOX followed by chemo-IMRT in patients with locally advanced unresectable pancreatic cancerocally advanced unresectable pancreatic cancerMedDRA version: 16.0Level: LLTClassification code 10033606Term: Pancreatic cancer non-resectableSystem Organ Class: 100000004864EUCTR2013-002074-46-ITIstituto Nazionale per lo Studio e la Cura dei Tumori di Napoli – Fondazione G.Pascale”47
尚未招募
2 期
Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel in Triple-negative Breast CancerTriple Negative Breast CancerNCT06407310Tel Aviv Medical Center25
撤回
2 期
Neoadjuvant Doxorubicin/Cyclophosphamide Followed by Eribulin Chemotherapy (ACE) in Operable HER2-negative Breast CancerBreast CancerNCT02215876Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
进行中（未招募）
不适用
A multicenter Phase II clinical trial of neoadjuvant trabectedin (Yondelis) in patients with localized myxoid / round cell liposarcoma. - NDocalized myxoid / round cell liposarcoma (MRCL).MedDRA version: 6.1Level: PTClassification code 10024630EUCTR2007-000035-25-ITPHARMA MAR22
进行中（未招募）
2 期
Neoadjuvant/Adjuvant Pembrolizumab Plus ChemotherapyNon Small Cell Lung CancerNeoadjuvant TherapyImmune Checkpoint InhibitorNCT05383716Peking Union Medical College Hospital80