NCT03768375

Molecularly Target Therapy With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

A Multicentre, Open-label, Randomised, Controlled Study of Molecularly Precision Target Therapy Based on Tumor Molecular Profiling With FORFIRINOX in Advanced or Recurrent Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility, efficacy and safety of target therapy according to genomic and proteomic profiling combined with FORFIRINOX in advanced or recurrent extrahepatic cholangiocarcinoma and gallbladder carcinoma.

Detailed description

Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status of signal pathways involved in study.These information will be used to recommend target therapy which may be more likely to result in a beneficial response.Patients will receive target anti-tumor agents according to the result of genomic and proteomic profiling.

Conditions

• Cholangiocarcinoma of the Extrahepatic Bile Duct
• Gallbladder Cancer

Interventions

Type	Name	Description
BIOLOGICAL	conventional chemotherapy(FORFIRINOX) combined with target agents	Drug: FORFIRINOX Conventional chemotherapy:gemcitabine and oxaliplatin Drug: Cetuximab Drug: Trastuzumab Drug: Gefitinib Drug: Lapatinib Drug: Everolimus Drug: Sorafenib Drug: Crizotinib
BIOLOGICAL	conventional chemotherapy(FORFIRINOX)	conventional chemotherapy(FORFIRINOX)

Timeline

• Start date: 2016-11-01
• Primary completion: 2020-12-30
• Completion: 2021-12-30
• First posted: 2018-12-07
• Last updated: 2018-12-07

Locations

1 site across 1 country: China