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

  • End date
    Sep 23, 2023
  • participants needed
  • sponsor
    Henan Provincial People's Hospital
Updated on 23 January 2021


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.

Condition Advanced Biliary Tract Cancers
Treatment cisplatin and nab-paclitaxel
Clinical Study IdentifierNCT04111380
SponsorHenan Provincial People's Hospital
Last Modified on23 January 2021


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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 1.510(9)/L, platelets 10010(9)/L, hemoglobin
g/L Liver functionTotal bilirubin 1.5x ULNAST and ALT) 2.5x ULN Renal
functionCr 1.5x ULNCcr 45 ml/min Coagulation functionINR1.5ULN, PT1.5ULN, 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 of- 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(BP160/95mmHg), 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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