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

Phase 2

• Conditions: Advanced Biliary Tract Cancers
• Interventions: Drug: cisplatin and nab-paclitaxel

• Registration Number: NCT04111380
• Lead Sponsor: Henan Provincial People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-09
• Study Start: 2019-09-24
• Study First Submitted: 2019-09-29
• Study First Submitted QC: 2019-09-30
• Last Update Submitted: 2019-09-30
• Study First Posted: 2019-10-01
• Last Update Posted: 2019-10-01
• Primary Completion: 2023-03
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective Response Rate [ORR]	2 years

Secondary Outcome Measures

Name	Time	Method
adverse events	2 years
Progression Free Survival [PFS]	2 years
Disease Control Rate [DCR]	2 years
Overall survival [OS]	2 years

Trial Locations

Locations (1)

Department of Oncology , Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, People's Hospital of Henan University; 🇨🇳 Zhengzhou, Henan, China