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.
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.
Locations (1)
Department of Oncology , Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University
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NCT04111380 - Efficacy and Safety Study of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers | Crick | Crick