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

NCT ID: NCT04111380

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-24
• Study Completion Date: 2023-09-30

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.

Conditions

Advanced Biliary Tract Cancers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nab-paclitaxel and Cisplatin

cisplatin and nab-paclitaxel: Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles.

Group Type: EXPERIMENTAL

cisplatin and nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles.

Interventions

cisplatin and nab-paclitaxel

Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSPC Ouyi Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Oncology , Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University

Zhengzhou, Henan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianwei Zhou, MD&PhD

Role: CONTACT

drzhoujw@163.com

13298360725

Facility Contacts

Jianwei Zhou, MD&PhD

Role: primary

drzhoujw@163.com

13298360725

Other Identifiers

Jianwei Zhou

Identifier Type: -

Identifier Source: org_study_id