Trastuzumab in HER2-positive Biliary Tract Cancer

Learn more about:
Related Clinical Trial
Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies Phase II Trial of Lenvatinib Plus Paclitaxel for Patients With Advanced Biliary Tract Cancer Who Failed to Gemcitabine-based Treatment Tislelizumab(Anti PD-1), Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer Phase Ib/II Single-arm Study of mFOLFOX6, Bevacizumab and Atezolizumab in Advanced Biliary Tract Cancer A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer Metabolic Stress-induced Exercise to Prevent Loss of Muscle Mass in Patients With Pancreatic and Biliary Tract Cancer The Registry of Genetic Alterations of Taiwan Biliary Tract Cancer A Study of ABL001 in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors Prognostic and Predictive Markers of Response to Treatment in Patients With Bile Duct Cancer: ACABi PRONOBIL Study Quality of Life of Patients Over 75 Yars Undergoing Palliative Chemotherapy Predicting Disease Progression and/or Recurrence in Cancer Basket Trial Exploring the Efficacy and Safety of the Combination of Niraparib and Dostarlimab Endoluminal Radiofrequency Ablation for the Treatment of Malignant Biliary Stenosis A Phase 1/2 Study of SC-43 in Combination With Cisplatin The Purpose of This Trial is to Determine if Regorafenib Plus Durvalumab (MEDI4736) is Safe and Effective in Treatment of Chemo Refractory Advanced Biliary Tract Cancers Phase II Study of Sitravatinib in Combination With Tislelizumab in Patients With Advanced Biliary Tract Cancer Camrelizumab Combined With Apatinib and Capecitabine in Patients With Advanced Unresectable Biliary Tract Cancer. A Study of Atezolizumab With or Without Bevacizumab in Combination With Cisplatin Plus Gemcitabine in Patients With Untreated, Advanced Biliary Tract Cancer A Phase II Study for Nab-paclitaxel Plus Cisplatin vs Gemcitabine Plus Cispatin as First Line Chemotherapy in Advanced Biliary Tract Cancer A Study of HA121-28 Tablets in Advanced Biliary Tract Cancer A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract Cancer A Trial of SHR1258 in Patients With Biliary Tract Cancer Perception Prognosis, Goals of Treatment, and Communication IL-2 Expressing, Attenuated Salmonella Typhimurium in Unresectable Hepatic Spread A Study to Assess the Safety, Tolerability and Anti-tumour Activity of Ascending Doses of Selumetinib in Combination With MEDI4736 and Selumetinib in Combination With MEDI4736 and Tremelimumab in Patients With Advanced Solid Tumours Adjuvant Capecitabine vs Gemcitabine Plus Cisplatin in Resected Extrahepatic Cholangiocarcinoma My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Tremelimumab With Chemoembolization or Ablation for Liver Cancer Preoperative Nutritional Support in Malnutritional Cancer Patients Multibending vs Conventional Endoscope for Direct Peroral Cholangioscopy Surgical Outcomes Database For Faculty of Hepatopancreatic Biliary Surgery SOX Sequential S-1 in Advanced Biliary Tract Carcinoma(BTC)and Pancreatic Cancer Effect of Early Management on PAin and DEpression in Patients With PancreatoBiliary Cancer, EPADE-PB Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) in Previously Treated Participants With Select Solid Tumors (MK-7902-005/E7080-G000-224/LEAP-005) Surgery Plus Celiac Nerve Block for Long-term Pancreatic Cancer Pain Control Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures. Parenteral Nutrition in Patients With Biliopancreatic Mass Lesions Early Palliative Care on Quality of Life of Advanced Cancer Patients Patient Activation Through Counseling, Exercise and Mobilization Extracellular RNA Markers of Liver Disease and Cancer X-MAS Biliary Study With Covered Biliary Stent A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 Anti-HER2 Therapy in Patients of HER2 Positive Metastatic Carcinoma of Digestive System The Efficacy and Safety of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma XELOX in Advanced Biliary Tract Carcinoma After Failure of Gemcitabine-based Chemotherapy Phase II Study of Refametinib, a MEK Inhibitor, as Second-line Treatment in Advanced Biliary Tract Adenocarcinoma Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma A Trial Evaluating Surufatinib Efficacy and Safety in Biliary Tract Carcinoma Patients Study of Surufatinib as Second-line Treatment in Patients With Biliary Tract Carcinoma A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma Combination of Targeted and Immunotherapy for Advanced Biliary Tract and Esophagogastric Gastric Cancer A Study of AbGn-107 in Patients With Gastric, Colorectal, Pancreatic or Biliary Cancer Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers A Prospective Cohort Study of Patients With Hepatobiliary Cancer Treated With Immune Checkpoint Inhibitors GTX Regimen for Biliary Cancers Phase II Study of Gemcitabine and TS-1 in Biliary Trat Cancer A Study Evaluating Safety, Pharmacokinetics, Pharmacodynamics, And Clinical Activity Of RO7119929 (TLR7 Agonist) In Participants With Unresectable Advanced Or Metastatic Hepatocellular Carcinoma, Biliary Tract Cancer, Or Solid Tumors With Hepatic Metastases A Phase I/II Study of the Pan-immunotherapy in Patients With Local Advanced/Metastatic BTC Varlitinib in Combination With Gemcitabine and Cisplatin for Treatment naïve Advanced or Metastatic BTC Phase II Study of SPI-1620 in Combination With Docetaxel as a Second-Line to Treat Biliary Cancer FOLFIRINOX for 2nd-line Treatment of BTC Study of PD-1 Inhibitor in Combination With Gemcitabine/Cisplatin for Advancer BTCs FOLFIRI as Salvage Treatment in Metastatic Biliary Tract Cancer (BTC) Patients Who Were Failed After Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study Pemetrexed in Combination With Erlotinib as a Salvage Treatment in Patients With Metastatic Biliary Tract Cancer (BTC) Who Failed Gemcitabine Containing Chemotherapy: A Phase II Single Arm Prospective Study Irinotecan, Gemcitabine, Chemotherapy for Biliary Tract Cancer Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy Study of Pembrolizumab in Metastatic Biliary Tract Cancer as Second-line Treatment After Failing to at Least One Cytotoxic Chemotherapy Regimen: Integration of Genomic Analysis to Identify Predictive Molecular Subtypes A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers Phase I Study of Gemcitabine or S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer Gemcitabine/Cisplatin/S-1(GCS) Combination Therapy for Patients With Advanced Biliary Tract Cancer Phase II Study of Gemcitabine Versus S-1 Adjuvant Therapy After Hemihepatectomy for Biliary Tract Cancer Docetaxel and Oxaliplatin Combination With Locally Advanced or Metastatic Biliary Tract Cancer A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma) Trastuzumab in HER2-positive Biliary Tract Cancer Study of Lenvatinib (E7080) in Unresectable Biliary Tract Cancer Who Failed Gemcitabine-based Combination Chemotherapy Study of D07001-Softgel Capsules in Subjects With Gastrointestinal Cancer in Dose-Escalation Phase and in Subjects With Biliary Tract Cancer in Dose-Expansion Phase Second Line Therapy in Advanced Biliary Tract Cancer Phase II Study of FOLFOXIRI in Patients With Locally Advanced or Metastatic Biliary Tract Cancer GAMBIT Trial: Cisplatin Plus Irinotecan in the Treatment of Gallbladder or Biliary Tract Cancer Study of TH-302 Monotherapy as Second-line Treatment in Advanced Biliary Tract Cancer Trial of Infusional FOLFIRINOX in First Line Treatment of Advanced Biliary Tract Cancers Phase Ib/II Trial of Nal-Irinotecan and Nivolumab as Second-Line Treatment in Patients With Advanced Biliary Tract Cancer Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer Gemcitabine+ Capecitabine Vs Capecitabine in Curatively Resected Biliary Tract Cancer Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer A Study of Selective HDAC6 Inhibition With KA2507 in Advanced Biliary Tract Cancer Varlitinib Plus Capecitabine in Chinese Patients With Advanced or Metastatic Biliary Tract Cancer Varlitinib in Combination With Capecitabine for Advanced or Metastatic Biliary Tract Cancer Oral Rehydration Therapy for Short Hydration in Chemotherapy With CDDP Plus GEM for Biliary Tract Cancer A Study of RC48 in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer. Case Series Study of Biliary Tract Cancer Patients in Japan GEM/Cisplatin/S-1 vs GEM/Cisplatin for Biliary Tract Cancer Molecular Profiling of Advanced Biliary Tract Cancers MEK162 in Combination With Capecitabine in Advanced Biliary Tract Cancer Allogeneic NK Cell (“SMT-NK”) in Combination With Pembrolizumab in Advanced Biliary Tract Cancer Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer Durvalumab (MEDI4736) and Tremelimumab and Radiation Therapy in Hepatocellular Carcinoma and Biliary Tract Cancer Toripalimab Combined With S1 and Albumin Paclitaxel in Patients With Advanced Biliary Tract Cancer Vessel Resection and Reconstruction of Biliary Tract Cancers Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancers A Phase I Study of Adjuvant Chemotherapy With GS in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy A Phase II Trial of Preoperative Chemotherapy for Biliary Tract Cancer (BTC) With Node Metastasis A Phase I Study of Adjuvant Chemotherapy With GC in Biliary Tract Cancer Undergoing Resection Without Major Hepatectomy Study of Nivolumab in Patients With Advanced Refractory Biliary Tract Cancers Study of the Combination of DKN-01 and Nivolumab in Previously Treated Patients With Advanced Biliary Tract Cancer (BTC) NGS as the First-line Treatment in Advanced Biliary Tract Cancer Identification of Prognostic Gene Mutations in Biliary Tract Cancer Using Whole Genome Sequencing NAPOLI-2: Fluorouracil, Leucovorin, and Nanoliposomal Irinotecan in Biliary Cancer Molecular Profiling of Advanced Biliary Tract Cancers

Brief Title

Trastuzumab in HER2-positive Biliary Tract Cancer

Official Title

The Pilot Study of Trastuzumab in Combination With Gemcitabine Plus Cisplatin for HER2-positive Biliary Tract Cancer

Brief Summary

      Trastuzumab is approved for the treatment of HER2-positive breast cancer and gastric cancer.
      The recent study showed that HER2 overexpression or amplification is noted about 5-15% of
      total biliary tract cancer patients. The aim of this study is to evaluate the efficacy and
      safety of trastuzumab in the combination of current standard gemcitabine plus cisplatin.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Response rate

Secondary Outcome

 Progression-free survival

Condition

Cholangiocarcinoma

Intervention

Trastuzumab

Study Arms / Comparison Groups

 Trastuzumab plus Gem/Cis
Description:  Gemcitabine 1,000 mg/m2 Day 1 and Day 8, every 3 weeks Cisplatin 25 mg/m2 Day 1 and Day 8, every 3 weeks Trastuzumab, every 3 weeks, 8 mg/kg at first cycle then, 6 mg/kg

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

4

Start Date

June 1, 2019

Completion Date

January 4, 2021

Primary Completion Date

November 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. The subject with disease that is not amendable to a curative treatment approach or
             locally advanced or metastatic or unresectable CCC with histological diagnosis

          2. At least one measurable(per RECIST 1.1) lesion

          3. Primary or metastatic tumor with HER2 positive defined on IHC2+, FISH+ or IHC3+

          4. ECOG Performance status 0 or 1

          5. At least 3 months for life expectancy Common inclusion criteria

          6. Men or women over 19 years at time of signing ICF

          7. Signed Informed Consent Form

             Exclusion Criteria:

          8. Received prior chemotherapy for advanced/metastatic disease (the adjuvant/neoadjuvant
             chemotherapy completed at least 6 months before enrolled will be accepted)

          9. Not recovery from toxicities related to any prior treatments excluding alopecia (eg,
             neurological toxicity to ≥ Grade 2)

         10. History of malignancy other than CCC within 5 years prior to screening, with the
             exception of malignancies with a negligible risk of metastasis or death, such as
             carcinoma in situ or thyroid papillary carcinoma Hematology, chemistry or organ
             function

         11. ANC < 1.5 × 109/L, or Platelet < 100 × 109/L

         12. Total bilirubin > 1.5 × ULN; or AST/ ALT > 2.5 × ULN (or if the tumor has expanded
             into the liver, > 5 × ULN); or, alkaline phosphatase > 2.5 × ULN (or > 5 × if the
             tumor has expanded into the liver, or > 10 × ULN if the tumor has expanded into the
             brain without liver,); or albumin < 2.5 g/dL

         13. Creatinine clearance < 60 mL/min(calculated using the Cockcroft-Gault formula) Other
             exclusion criteria related to IP

         14. History of proved congestive heart failure; angina with medication; evidence of
             transmural myocardial infarction on ECG; uncontrolled hypertension(systolic> 180 mmHg
             or diastolic> 100 mmHg); clinically significant heart valve disease; uncontrolled
             arrhythmia

         15. LVEF < 50% (calculated by cardiac sonography or MUGA)

         16. Subject with rest dyspnea due to metastatic tumor or other disease or who needs oxygen
             therapy

         17. Chronic or high-dose corticosteroid treatment

         18. Clinically significant Hearing impairment Common exclusion criteria

         19. History or evidence of CNS metastases

         20. Interstitial pneumonia or pulmonary fibrosis with symptom and exact lesion on chest
             X-ray

         21. Hearing loss

         22. Uncontrolled significant systemic disease (eg, infection or uncontrolled DM)

         23. Pregnant or lactating females

         24. Sexually active fertile subjects without contraception

         25. Treatment with other investigational therapy within 4 weeks prior to initiation of
             study treatment

         26. Radiotherapy within 4 weeks prior to initiation of study treatment (the rest at least
             2 weeks after palliative radiotherapy for bone metastasis and recovery from the
             effects of radiation will be accepted.)

         27. Major surgery within 4 weeks prior to initiation of study treatment

         28. History of HIV and active HBV or HCV

         29. Previously identified allergy or hypersensitivity to components of the study treatment
             formulations
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Changhoon Yoo, MD, , 

Location Countries

Korea, Republic of

Location Countries

Korea, Republic of

Administrative Informations


NCT ID

NCT03613168

Organization ID

BTC-HER2


Responsible Party

Sponsor-Investigator

Study Sponsor

Changhoon Yoo


Study Sponsor

Changhoon Yoo, MD, Principal Investigator, Asan Medical Center


Verification Date

January 2021