Efficacy and Safety Study of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers: a Prospective, Open Label, Single-arm Phase II Trial

Conditions
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Advanced Biliary Tract Cancers

Intervention / Treatment
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* Drug: cisplatin and nab-paclitaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nab-paclitaxel and Cisplatin<br>cisplatin and nab-paclitaxel: Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles. | Drug: cisplatin and nab-paclitaxel<br>* Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate [ORR] |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival [PFS] |  | 2 years | 
| Overall survival [OS] |  | 2 years | 
| Disease Control Rate [DCR] |  | 2 years | 
| adverse events |  | 2 years |