NCT04692051Unknown2 期
A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
It is a trial to compare the efficacy and safety of Nab-paclitaxel plus Cisplatin vs Gemcitabine plus Cispatin as first line chemotherapy in advanced biliary tract cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Aged 18 to 70 years;
- •Diagnosis of unresectable or recurrent or metastatic biliary tract cancer (Ampulla of Vater, gallbladder, intra or extra-hepatic biliary ducts);
- •Adequate bone marrow, liver and kidney function: absdute neutrophil count (ANC) ≥ 1.5 x 10^9/L, platelet count (PLT) ≥75 x 10^9/L, hemoglobin (HB) ≥ 75 g/L, White blood cell(WBC) ≥ 3.0 x 10^9/L, no bleeding symptoms or bleeding tendency; Total bilirubin (TBIL) ≤ 3 x upper limit of normal range (ULN), alanine glutamate transaminase (ALT) and glutamate transaminase (AST) ≤ 5 x upper limit of normal range (ULN); creatinine(Cr) ≤ 1.5 x upper limit of normal range(ULN) or creatinine clearance rate（CCR）≥ 45ml/min;
- •At least one measurable lesion;
- •Karnofsky Performance Status(KPS) ≥ 70;
- •Estimated life expectancy of at least 3 months;
- •Resolution of all acute clinical toxic effects of any prior treatment to grade ≤ 1, with the exception of alopecia;
- •Be able to understand and willingness to sign IRB-approved informed consent; (If the patient cannot sign the informed consent due to consciousness disorder, upper limbs paralysis or inability to write, the legal representative shall sign the informed consent on behalf of the patient).
排除标准
- •Ongoing uncontrolled infections, or have received systemic antibiotic therapy within 72 hours prior to registration;
- •Myeloproliferative disorder or any other hematopoietic function disorder;
- •Have an untreated second malignancy or brain metastasis;
- •Allergic to the chemotherapy drugs of this protocol;
- •Unable to cooperate due to neurologic diseases or psychiatric illness;
- •Pregnant or lactating female patients; Women of child-bearing age who refuse to accept contraceptive measures;
- •Have other significant medical illness, for example,active tuberculosis, active pneumonia, uncorrected electrolyte disturbance, uncontrolled tumor associated pain, uncontrolled hydrothorax or seroperitoneum and so on;
- •Patients need to receive other antitumor therapy at the same time;
- •Have received any other experimental treatment or participated in another interventional clinical trial within 30 days prior to registration;
- •Any other situation that the researcher considered patients are unsuitable for the trial.
研究组 & 干预措施
Nab-paclitaxel + Cisplatin
Experimental
Patients in this arm receive chemotherapy with Nab-paclitaxel plus Cisplatin
干预措施: Nab-paclitaxel + Cisplatin (Drug)
Gemcitabine + Cisplatin
Active Comparator
Patients in this arm receive chemotherapy with Gemcitabine plus Cisplatin
干预措施: Gemcitabine + Cisplatin (Drug)
结局指标
主要结局
PFS
时间窗: up to 3 years
PFS is defined as time from the start of treatment to progression of disease or death.
次要结局
- OS(up to 3 years)
- AEs(up to 3 years)
- TTP(up to 3 years)
- ORR(up to 3 years)
研究者
Xianglin Yuan
Professor, Head of the cancer center
Huazhong University of Science and Technology
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Gemcitabine Hydrochloride, Cisplatin, and Nab-Paclitaxel in Treating Patients With Advanced or Metastatic Biliary CancersStage III Intrahepatic Cholangiocarcinoma AJCC v7Stage IIIA Gallbladder Cancer AJCC v7Stage IIIB Gallbladder Cancer AJCC v7Stage IVA Gallbladder Cancer AJCC v7Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7Stage IVB Gallbladder Cancer AJCC v7Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7Unresectable Extrahepatic Bile Duct CarcinomaUnresectable Gallbladder CarcinomaNCT02392637M.D. Anderson Cancer Center62
进行中（未招募）
2 期
Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic AdenocarcinomaPancreatic Ductal AdenocarcinomaNCT03915444HonorHealth Research Institute42
Unknown
2 期
Study of Gemcitabine Plus Nab-paclitaxel Versus S1 Plus Nab-paclitaxel in Metastatic Adenocarcinoma of the PancreasNab-paclitaxelGemcitabineS1Pancreatic CancerNCT03779464Wuhan Union Hospital, China132
招募中
2 期
Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder CancerGallbladder Cancer UnresectableNCT06591650Fudan University33
已完成
2 期
Nab-Paclitaxel Plus Gemcitabine Versus Gemcitabine For The First Line Treatment of Pancreas CancerPancreatic NeoplasmNCT03807999Hacettepe University125