Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma

Learn more about:
Related Clinical Trial
Liver Embolization Approaches for Tumor Management Study on the Accuracy of Proteomics in Evaluating Lymph Node Metastasis Status in Cholangiocarcinoma Patients Evaluation of the Patient’s Experience in Medical Studies for Cholangiocarcinoma Looking At Bile Duct Cancer Patient Experience Patterns in Medical Trials Advanced or Metastatic Cholangiocarcinoma Study of [18F]FAPI-74 PET in Patients With Gastrointestinal Cancers Study on Consistency Evaluation for Drug Sensitivity of Patient-Derived Organoid Model From Cholangiocarcinoma Patients Screening Single-operator Cholangioscopy for Neoplastic Bile Duct Lesions EUS-guided Choledochoduodenostomy for Primary Drainage of Malignant Distal Biliary Obstruction An Exploratory Clinical Study of Photodynamic Therapy Combined With Sonodynamic Therapy in Cholangiocarcinoma Bile Duct Drainage After ERCP Failure: EUS-BD vs PTBD Safety and Efficacy of PDT vs RFA vs PDT+RFA for the Treatment of Extrahepatic Cholangiocarcinoma FLUOPANC-trial – Fluorescence-guided Surgery of Pancreatic and Bileduct Tumors Using cRGD-ZW800-1 Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma QoL After Liver Surgery CH-EUS in Diagnosis of Inoperable Bile Duct Tumors Treatment of ARB202 Advanced Gastrointestinal Cancer Patients Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines. GEMOX Combined With Targeted Therapy and Immunotherapy for Patients With Advanced Cholangiocarcinoma PD-1 Inhibitor Sintilimab Combined With Capecitabine for Adjuvant Treatment After Radical Resection of Cholangiocarcinoma. Phase I/II Study of Autologous T Cells to Express T-Cell Receptors (TCRs) in Subjects With Solid Tumors Molecular Epidemiology of Biliary Tree Cancers Prognostic Factors in Periampullary Tumors and Cysts RALOX as Second Line Treatment for Advanced Malignant Biliary System Tumor HLA Typing and Tumor Neoantigen Identification for a Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor Deep Liver Phenotyping and Immunology Study A Study of MGD013 in Patients With Unresectable or Metastatic Neoplasms Radio Frequency Ablation in the Management of Pancreatico-biliary Disorders: A Multicenter Registry. Maintenance Niraparib and Dostarlimab in Advanced Cholangiocarcinoma A Phase I Study of WM-S1-030 in Patients With Advanced Solid Tumors Niraparib Combined With Anlotinib in Homologous Recombination Repair (HRR) Gene-mutated Advanced Solid Tumors The Comparison of Miniinvasive and Open Pancreaticoduodenectomy for Cancer Pancreaticobiliary Zone Crossover Relative Bioavailability and Dose Escalation Study of TT-00420 Tablet in Patients With Advanced Solid Tumors Neoadjuvant Bintrafusp Alfa in Patients With Resectable Biliary Tract Cancer Open-Label Study for Safety, Tolerability, PK and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced/Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma LYT-200 Alone and in Combination With Chemotherapy or Anti-PD-1 in Patients With Metastatic Solid Tumors Lenvatinib in Patients With Previously Treated Advanced Biliary Tract Cancer A Study of BMS-936558 With SBRT After Induction Chemotherapy in Cholangiocarcinoma Apatinib Plus Camrelizumab in Patients With Previously Treated Advanced Biliary Tract Cancer Phase I/II Study Evaluating Safety and Efficacy of Tivozanib (AV-951) in Cholangiocarcinoma ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY Recurrence After Whipple’s (RAW): Retrospective Cohort Study Investigating Patterns of Cancer Recurrence Following Pancreaticoduodenectomy for Pancreatic Head Malignancy Implementing Acupuncture and Chinese Herbal Medicine Into Palliative Care Prospective Evaluation of Biliary Tissue Sampling With ERCP Combination of Trametinib (MEK Inhibitor) and Hydroxychloroquine (HCQ) (Autophagy Inhibitor) in Patients With KRAS Mutation Refractory Bile Tract Carcinoma (BTC). DNA Methylation Biomarker for Diagnosis of Cholangiocarcinoma in Patients With Bile Duct Stricture Liver Cancer Registry Platform Target Rare Cancer Knowledge Neoadjuvant Therapy in Biliary Adenocarcinoma BOLD-100 in Combination With FOLFOX for the Treatment of Advanced, Solid Tumours the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients Nutritional Preferences and Product Accessibility in Oral Nutritional Supplements in Participants With Breast, Colorectal, Upper Gastrointestinal, or Prostate Cancer High Volume Washing of the Abdomen in Increasing Survival After Surgery in Patients With Pancreatic Cancer That Can Be Removed by Surgery Short-term Starvation vs. Normal Diet Before Chemotherapy of Solid Tumors Evaluation of MRI Sequences for Ultra-rapid Acquisition of Bile Ducts Images Study of Oral Ceritinib in Patients With ALK and ROS1 Activated Gastrointestinal Malignancies Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer Improving Outcomes in Cancer Patients With a Nutritional and Physical Conditioning Prehabilitation Program 18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant A Clinical Trial to Evaluate Safety and Efficacy of Endovascualr Denervation in Treatment of Cancer Pain Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors Anesthetic Agents and Acute Kidney Injury After Liver Resection Surgery Efficacy of Fistulotomy for Biliary Cannulation A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors Etomidate vs. Midazolam for Sedation During ERCP Loop-tipped Guidewire in Selective Biliary Cannulation Pancreatic Head and Peri-ampullary Cancer Laparoscopic vs Open Surgical Treatment Trial (PLOT) Effects of OXY111A in Primary and Secondary Hepato-Pancreato-Biliary Neoplasm BKM120 in Cancers With PIK3CA Activating Mutations A First-in-human Phase Ia/b, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Patients With Advanced Gastrointestinal Cancers Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT PTFE Stents for Treatment of Malignant Biliary Strictures Irreversible Electroporation of Unresectable Liver Tumors Personal Resilience Empowerment Program Study Radiofrequency Ablation for Biliopancreatic Malignancy Early Enteral Feeding After Pylorus Preserving Pancreatoduodenectomy Influence of an Oral Nutritional Supplement Rich in Omega-3 Fatty Acids on Functional State and Quality of Life in Malnourished Patients With Gastroenterological Tumors National Translational Science Network of Precision-based Immunotherapy for Primary Liver Cancer In Vitro Models of Liver and Pancreatic Cancer Biliary Tissue Sampling Using a Cytology Brush or the GIUM Catheter Evaluation of Stereotactic Radiosurgery For Liver Malignancies Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy Radiofrequency Ablation Using Octopus Electrodes for Treatment of Focal Liver Malignancies Accuracy of Endoscopic Ultrasound for Detection of Tumors of the Liver Prospective Study of the Risk of Bacteremia in Directed Cholangioscopic Examination of the CBD Margin Status After Pancreaticoduodenectomy for Cancer A Pilot Study of Combined Immune Checkpoint Inhibition in Combination With Ablative Therapies in Subjects With Hepatocellular Carcinoma (HCC) or Biliary Tract Carcinomas (BTC) Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors Comparison Bile Duct Brushings, Cholangioscopy-Directed Biopsies and Pediatric Forceps Biopsies in Biliary Strictures Effects of Preoperative Immunonutrition in Patients Undergoing Pancreaticoduodenectomy A Study of BBI503 in Adult Patients With Advanced Hepatobiliary Cancer A Study of TRK-950 in Patients With Advanced Solid Tumors Combined HCC-MFCCC Proton Therapy and Bevacizumab for Primary Liver Tumors Effects of Preoperative Immunonutrition in Patients Undergoing Hepatectomy Proton Beam Irradiation for the Treatment of Unresectable Hepatocellular Cancer or Hepatic Metastases Fluorescence QRH-882260 Peptide Imaging in the Bile Duct A Phase 1 Study of ZSP1241 in Participants With Advanced Solid Tumors pCLE For the Diagnosis Of Cancer in Unknown Bile Duct Stricture Unilateral Versus Bilateral Stents for Bismuth Type II and III Malignant Hilar Strictures Yttrium-90 Radioembolization Using Glass Microspheres (TheraSphere) for Patients With Liver Metastases Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations Study of Sildenafil as a Therapy for Fatigue in Pancreatic Cancer Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer MRCP Diagnoses EHCC Better When Combined DWI Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours Comparison of Biliary Forceps Biopsy and Brush Cytology Perioperative MVT-5873, a Fully Human Monoclonal Antibody Against a CA 19-9 Epitope, for Operable CA 19-9 Producing Pancreatic Cancers, Cholangiocarcinomas, and Metastatic Colorectal Cancers Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma Endoscopic Bipolar Radiofrequency Probe (ENDOHPB) in the Management of Unresectable Bile Duct and Pancreatic Cancer A Registry of Patients Undergoing Cellvizio Endomicroscopy and Endoscopic Retrograde Cholangiopancreatography(ERCP) Imaging Procedures for Diagnosing Pancreatic and Bile Duct Cancers Cyclooxygenase-2 Inhibitor for Adjuvant Anticancer Effect in Patients With Biliary-pancreas Cancer Endobiliary RFA for Unresectable Malignant Biliary Strictures A Clinical Trial of Entinostat in Combination With Nivolumab for Patients With Previously Treated Unresectable or Metastatic Cholangiocarcinoma and Pancreatic Adenocarcinoma Clinical Effect and Safety of PDT and RFA for Unresectable EHCC Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma Gemcitabine With Peptide Vaccine Therapy in Treating Patients With Bile Duct Cancer A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma Trial of IRE in Cholangiocarcinoma Intra-hepatic Chemotherapy in Patient With Non-resectable Liver Metastases From Cholangiocarcinoma Chemo Alone or in Combination With Radiation in Unresectable Cholangiocarcinoma ASLAN001 in Patients With Advanced or Metastatic Cholangiocarcinoma Who Progressed on at Least 1 Line of Systemic Therapy A Study of Gemcitabine as an Adjuvant Treatment for Cholangiocarcinoma After Surgical Resection Efficiency Evaluation of Photodynamic Therapy With Photofrin® on Unresectable Type III or IV Cholangiocarcinomas PCI Treatment/Gemcitabine & Chemotherapy vs Chemotherapy Alone in Patients With Inoperable Extrahepatic Bile Duct Cancer S-1 in Combination With Abraxane in Treating Cholangiocarcinoma Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma Combination Chemotherapy Plus Panitumumab or Bevacizumab for Inoperable Cholangiocarcinoma Without KRAS Mutations A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma Diagnosis, Treatment Status and Prognosis of Cholangiocarcinoma in China: a Multicenter, Two-way, Non-intervention Study Gemcitabine/Oxaliplatin and Photodynamic Therapy in Cholangiocarcinoma Efficacy and Safety of Pemigatinib in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Who Failed Previous Therapy – (FIGHT-202) Pemigatinib in Treating Patients With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including FGFR2 Rearrangement Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Cholangiocarcinoma Chart Review: Unresectable/Metastatic Cholangiocarcinoma Treated With Irinotecan, Capecitabine and Celecoxib Study of TRIFLURIDINE/TIPIRACIL in Previously Treated Cholangiocarcinoma Study Of Intrahepatic Arterial Injection of 90-Y Glass Microspheres for Cholangiocarcinoma Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma Neoadjuvant mFOLFOXIRI for Potentially Resectable Cholangiocarcinoma Gemcitabine, Oxaliplatin and Capecitabine in Patients With Advanced Cholangiocarcinoma Registry Study of Neoadjuvant Chemoradiation & Transplant for Cholangiocarcinoma Patients Study of RAD001 in Advanced Cholangiocarcinoma: RADiChol Study of Pembrolizumab and Olaparib in Bile Duct Cancer Cohort of Patients With Hepatocellular Carcinoma or Cholangiocarcinoma Second Line Chemotherapy FOLFIRINOX in Irresectable Cholangiocarcinoma ncRNAs in Exosomes of Cholangiocarcinoma Single Arm Study of RAD001 as Monotherapy in Treatment in Advanced Cholangiocarcinoma Trial of Therapeutic Vaccine in Patients With Cholangiocarcinoma

Brief Title

Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Cholangiocarcinoma

Official Title

A Multi-Institutional, Single Arm, Two-Stage Phase II Trial of Nab-Paclitaxel and Gemcitabine for First-Line Treatment of Patients With Advanced or Metastatic Cholangiocarcinoma

Brief Summary

      Patients with advanced or metastatic cholangiocarcinoma (CCA) who are not eligible for
      curative surgery, transplantation, or ablative therapies will receive nab-paclitaxel and
      gemcitabine chemotherapy.

      The purpose of this study is to evaluate the effectiveness and safety of the combination of
      nab-paclitaxel and gemcitabine. The effectiveness will be determined by improvement in the
      length of time during and after treatment, that the CCA does not get worse.

Detailed Description

      Advanced cholangiocarcinomas (CCAs) are aggressive tumors with median survival time after
      diagnosis of less than 12 months, and five-year overall survival (OS) of ~5% with systemic
      chemotherapy. Currently available systemic therapies for CCA are largely ineffective, thus
      the rationale for the proposed research is to investigate targeted delivery of chemotherapy.

      The goal of this study is to evaluate the efficacy of gemcitabine plus nab-paclitaxel in
      patients with advanced CCA. This is based on the premise that nab-paclitaxel binds to SPARC
      (secreted protein acidic and rich in cysteine) through its interaction with albumin, leading
      to an increase in intra-tumoral concentration of gemcitabine through decreased deoxycytidine
      deaminase (CDA) enzyme. We hope to improve on the OS of patients with advanced CCA through
      the use of the synergistic combination of nab-paclitaxel and gemcitabine to specifically
      target the SPARC protein in the peri-tumoral stroma. We aim to provide critical data to
      further develop pharmacologic strategies to target the desmoplastic stroma in order to
      increase chemotherapy responsiveness of CCAs.

      We will also examine whether circulating tumor cell (CTC) levels with targeted gene
      expression analysis and stromal SPARC levels correlate with patient outcome and thus serve as
      prognostic biomarkers. We will evaluate the role of Human Equilibrative Nucleoside
      Transporter 1 (hENT1), CDA and tumor fibrosis as additional prognostic and predictive
      biomarkers in CCA. This clinical trial hopes to improve on the poor prognosis of patients
      with advanced CCA by establishing the activity of a platinum-free doublet, nab-paclitaxel
      plus gemcitabine that has shown clear clinical benefit in pancreatic cancer which has close
      biological parallels to CCA.

      A maximum of 70 patients will be enrolled to attain 67 eligible/evaluable patients. Stage I
      will enroll 37 patients. If 21 or more patients are alive and progression-free at 6 months,
      the study will proceed to Stage II and an additional 33 patients will be enrolled.

      Procurement of archived tissue, if available, from a previous diagnostic biopsy is mandatory
      for enrollment. If not available, this will not preclude participation in the trial, nor will
      additional biopsies be performed for research purposes only.

      Optional blood samples will be requested.

Study Phase

Phase 2

Study Type


Primary Outcome

Progression-Free Survival (PFS) Rate at 6 Months (Proportion of Participants Alive and Progression-Free at 6 Months)

Secondary Outcome

 Overall Survival (OS)




Nab-Paclitaxel and Gemcitabine

Study Arms / Comparison Groups

 Nab-Paclitaxel and Gemcitabine
Description:  Nab-Paclitaxel 125 mg/m² IV and Gemcitabine 1000 mg/m² on days 1, 8 and 15 every 28 days until progression or unacceptable toxicity.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

December 9, 2014

Completion Date

October 1, 2017

Primary Completion Date

September 24, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Must have histologically-confirmed diagnosis of cholangiocarcinoma Stage II, III, or
             IV CCA (intra-hepatic, extra-hepatic and perihilar) that is not eligible for curative
             resection, transplantation, or ablative therapies. Tumors of mixed histology are not

          -  Must have radiographically measurable disease in at least one site not previously
             treated with radiation, chemoembolization, radioembolization, or other local ablative
             procedures; a new area of tumor progression within or adjacent to a previously-treated
             lesion, if clearly measurable by a Radiologist, is acceptable.

          -  May have received prior radiation, chemoembolization, radioembolization, or other
             local ablative therapies, or hepatic resection if completed ≥ 4 weeks prior to
             registration AND if patient has recovered to ≤ grade 1 toxicity. NOTE: Measurable
             disease (as required above) must still be present.

          -  May have received prior radiation for bone or brain metastases if patient is now
             asymptomatic and has completed all radiation and steroid therapy (if applicable) ≥ 2
             weeks prior to registration.

          -  Age ≥ 18 years.

          -  Child-Pugh score of A or B with ≤ 7 points.

          -  Eastern Cooperative Oncology Group performance status of 0-1.

          -  Willing to provide archived tissue, if available, from a previous diagnostic biopsy.

          -  Must be able to tolerate CT and/or MRI with contrast.

          -  Adequate organ function obtained ≤ 2 weeks prior to registration:

               -  Absolute Neutrophil Count ≥ 1500/mm³

               -  Hemoglobin ˃9.0 g/dL

               -  Platelets ˃100,000/mm³

               -  Serum Creatinine ≤ 1.5x Upper Limit Normal (ULN)

               -  Creatinine Clearance ≥ 50 mL/min

               -  Albumin ≥ 2.8 g/dL

               -  Total Bilirubin ≤ 1.5 mg/dL or ≤ 1.5x ULN

               -  Aspartate Aminotransaminase (AST)/Alanine Aminotransaminase (ALT) ≤ 2.5x ULN (≤
                  5x ULN in patients with liver metastases)

               -  International Normalized Ratio (INR) <1.5x the ULN [INR ≥ 1.5 is allowed if
                  anticoagulation is used.]

          -  Women must not be pregnant or breastfeeding since nab-paclitaxel and/or gemcitabine
             may harm the fetus or child.

          -  Must not have received prior systemic cytotoxic chemotherapy or targeted therapy for
             this cancer.

          -  Must not be receiving treatment with other investigational agents.

          -  Must not have a pre-existing >grade 2 peripheral neuropathy.

          -  Must not be receiving immunosuppressive medications, including systemic
             corticosteroids, aside from the following exceptions: used for adrenal replacement,
             appetite stimulation, therapy for asthma, bronchitis exacerbation (≤ 2 weeks),
             anti-emesis, or pre-medication for procedures (i.e. CT scan).

          -  No known Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV)

          -  Must not have undergone liver transplantation.

          -  Must not have serious non-healing wound, ulcer, bone fracture, or abscess.

          -  Must not have undergone a major surgical procedure <4 weeks prior to registration.

          -  Must not have possible histories of pneumonitis or pneumonitis risk factors.

          -  Must not have an active second malignancy other than non-melanoma skin cancer or
             cervical carcinoma in situ.

          -  Must have no ongoing or active, uncontrolled infections.

          -  Must have no evidence of significant, uncontrolled concomitant diseases including, but
             not limited to: symptomatic congestive heart failure, unstable angina pectoris,
             uncontrolled cardiac arrhythmia, myocardial infarction within preceding 12 months,
             uncontrolled peripheral vascular disease, cerebrovascular accident within preceding 12
             months, pulmonary disease impairing functional status or requiring oxygen, connective
             tissue disease including lupus.

          -  Must not have any history of allergic reaction(s) attributed to compounds of similar
             composition to nab-paclitaxel or gemcitabine.




18 Years - N/A

Accepts Healthy Volunteers



Vaibhav Sahai, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor



 Celgene Corporation

Study Sponsor

Vaibhav Sahai, MD, Study Chair, University of Michigan Health System in Ann Arbor, MI

Verification Date

September 2018