Advanced Biliary Tract Cancers
Conditions
Brief summary
To verify the role of nab-paclitaxel in second or later-line treatment in advanced biliary tract cancers, the investigators designed a prospective, exploratory, single arm,single center phase II trial, to investigate the efficacy and safety of nab-paclitaxel combined with cisplatin as second or later-line treatment in advanced biliary tract cancers.
Interventions
DRUGcisplatin and nab-paclitaxel
Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles.
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Henan Provincial People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age ranges from 18 to 75 years * Radiographically, histologically or/and cytologically diagnosed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer. * Received at least one first-line systemic treatment for advanced or metastatic diseases and failed, with imaging evidence of disease progression. * ECOG performance status 0-1 * According to the RECIST1.1 standard, at least one measurable objective lesion should be judged. * Expected survival more than 12 weeks * The laboratory test meet the following requirements: Bone marrow function: neutrophils ≥ 1.5×10(9)/L, platelets ≥ 100×10(9)/L, hemoglobin ≥ 90 g/L Liver function：Total bilirubin ≤ 1.5x ULN；AST and ALT) ≤ 2.5x ULN Renal function：Cr ≤ 1.5x ULN，Ccr ≥ 45 ml/min Coagulation function：INR≤1.5×ULN, PT≤1.5ULN, APTT within the normal range * Not concomitant with other uncontrollable benign disease before the recruitment(e.g. the infection in the kidney, lung and liver). * During the non-lactation period, contraceptive measures should be taken in patients of child-bearing age during this trial. The test ofβ- HCG was negative. * The patient has good compliance with the planned treatment, understands the research process of the study and signs a written informed consent form
Exclusion criteria
* With Chemotherapy contraindication, known to be allergic, highly sensitive or intolerable to research-related drugs or excipient. * Pregnant or lactating women. * Refuse or fail to sign informed consent to participate in the trial * Grade 2 or above peripheral neuropathy or hemorrhage according to NCI CTCAE 4.03 * Combined with severe cardiovascular disease, including hypertension that cannot be controlled by medical treatment(BP≥160/95mmHg), unstable angina, a history of myocardial infarction in the past 6 months,Congestive heart failure\>NYHA grade II, severe arrhythmia, pericardial effusion, etc. * Patients with severe systemic infections or other serious diseases. * Combined with other primary tumors * Patients not suitable for the group according to the judgement of the researcher, with mental disease. * Patients with symptomatic central nervous system (CNS) metastases who require radiotherapy, surgery or sustained corticosteroid use, and untreated brain metastases that cause any symptoms * Prior exposure to nab-paclitaxel * The investigator determined that unable to complete the study due to medical, social, or psychological reasons or were unable to sign valid informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate [ORR] | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival [PFS] | 2 years |
| Overall survival [OS] | 2 years |
| Disease Control Rate [DCR] | 2 years |
| adverse events | 2 years |
Countries
China
Contacts
Primary ContactJianwei Zhou, MD&PhD
Outcome results
None listed