Clinical trial NCT04111380: Efficacy and Safety Study of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Advanced Biliary Tract Cancers
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: CSPC Ouyi Pharmaceutical Co., Ltd.
First posted: 2019-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective Response Rate [ORR]
timeFrame: 2 years
Secondary outcomes:
measure: Progression Free Survival [PFS]
timeFrame: 2 years
measure: Overall survival [OS]
timeFrame: 2 years
measure: Disease Control Rate [DCR]
timeFrame: 2 years
measure: adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Department of Oncology , Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University
state: Henan
Study officials:
References: