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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Biliary Tract Cancers
• Intervention / Treatment: Drug: cisplatin and nab-paclitaxel

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jianwei Zhou, MD&PhD; Phone Number: 13298360725; Email: drzhoujw@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Recruiting
      • Department of Oncology , Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University
      • Contact: Jianwei Zhou, MD&PhD; Phone Number: 13298360725; Email: drzhoujw@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henan Provincial People's Hospital
• Collaborators: CSPC Ouyi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: September 29, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (Actual): October 1, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Cisplatin
• Other Study ID Numbers: Jianwei Zhou

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No