Combined Biological Treatment and Chemotherapy for Patients With Inoperable 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

Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Official Title

Combined Biological Treatment and Chemotherapy for Patients With Inoperable Cholangiocarcinoma

Brief Summary

      The purpose of this study is partly to continue the good experience the investigators have
      with chemotherapy and partly to optimize treatment of inoperable cholangiocarcinoma by adding
      a biological antibody to the treatment of patients with wild-type Kirsten rat sarcoma viral
      oncogene homolog (KRAS).
    

Detailed Description

      Cholangiocarcinoma is a relatively rare disease. In Denmark approximately 150 patients are
      diagnosed each year. A small part of the patients can be offered surgery, but the operation
      will rarely be radical, and most patients with cholangiocarcinoma are therefore candidates
      for chemotherapy.

      In Denmark the combination therapy of Gemcitabine, Oxaliplatin and Capecitabine has been used
      in recent years. Based on experience with gastrointestinal tumors, however, there seems to be
      an effect of new biological substances, including EGFR antibodies. There are casuistic
      reports on the specific effect of a monoclonal antibody against EGFR in cholangiocarcinoma.

      The effect of EGF is mediated through an intracellular pathway involving the KRAS protein. It
      has been shown that a mutation of KRAS causes the EGF system to be constantly activated.
      Effect in patients with a KRAS mutation is therefore not to be expected. Approximately 50% of
      the patients present this mutation.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Progression free survival

Secondary Outcome

 Response rate

Condition

Cholangiocarcinoma

Intervention

Gemcitabine, Oxaliplatin, Capecitabine,

Study Arms / Comparison Groups

 KRAS wildtype
Description:  

Publications

* 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

Drug

Estimated Enrollment

72

Start Date

September 2008

Completion Date

March 2016

Primary Completion Date

March 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically verified adenocarcinoma arisen from gallbladder, extra or intrahepatic
             bile ducts or malignant cells consistent with the above and concomitant radiologic
             findings consistent with cholangiocarcinoma.

          -  Curative treatment presently discounted (surgery, stereotactic radiotherapy, etc.)

          -  KRAS analyzed and found wild-type (wt) or mutated

          -  PS 0-2

          -  Evaluable disease according to RECIST criteria, i.e., the disease does not need to be
             measurable

          -  Haematology:

               -  ANC ≥ 1.5 x 10^9/l

               -  Thrombocytes ≥ 100x10^9/l

          -  Biochemistry:

               -  Bilirubinaemia ≤ 3 x upper normal value

               -  ALAT ≤ 5 x upper normal value

          -  Creatinin ≤ upper normal value. If raised creatinin, the measured or calculated GFR
             must be at least 50% of the lower normal value.

          -  Fertile women must present a negative pregnancy test and use birth control during and
             3 months after treatment. The following methods are considered safe birth control:
             Birth control pills, coil, gestagen deposit injection, subdermal implantation,
             hormonal vagina ring, and transdermal deposit band-aid)

          -  Oral and written informed consent

        Exclusion Criteria:

          -  Chemotherapy within 4 weeks

          -  Radiotherapy within 4 weeks

          -  Immunotherapy within 4 weeks

          -  Other concomitant experimental treatment

          -  Known neuropathy ≥ grade 2

          -  Serious congruous medical disease

          -  Other previous malignant disease within 5 years, excl. non-melanoma skin cancer and
             carcinoma in situ cervicis uteri

          -  Previous serious and unexpected reactions to fluoropyrimidine treatment

          -  Hypersensitivity to one or more of the active substances, auxiliary substances or
             fluoruracil

          -  Patients with interstitial pneumonitis or pulmonary fibrosis
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Anders Jakobsen, DMSc, , 

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations


NCT ID

NCT00779454

Organization ID

GOX-P

Secondary IDs

S-20080081

Responsible Party

Sponsor

Study Sponsor

Vejle Hospital


Study Sponsor

Anders Jakobsen, DMSc, Study Chair, Vejle Hospital, Vejle, Denmark


Verification Date

June 2016