Status:
UNKNOWN
Efficacy and Safety Study of Nab-Paclitaxel Combined With Cisplatin in Second or Later-Line Treatment in Advanced Biliary Tract Cancers
Lead Sponsor:
Henan Provincial People's Hospital
Collaborating Sponsors:
CSPC Ouyi Pharmaceutical Co., Ltd.
Conditions:
Advanced Biliary Tract Cancers
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04111380
Start Date
September 24 2019
End Date
September 1 2023
Last Update
October 1 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Oncology , Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University
Zhengzhou, Henan, China, 450003