NCT02836847

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (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 GEMOX 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
PROCEDURE	biological test	mutation and signal pathway activation status analysis
DRUG	GEMOX	Conventional chemotherapy:gemcitabine and oxaliplatin
DRUG	Cetuximab
DRUG	Trastuzumab
DRUG	Gefitinib
DRUG	Lapatinib
DRUG	Everolimus
DRUG	Sorafenib
DRUG	Crizotinib

Timeline

• Start date: 2016-07-01
• Primary completion: 2019-12-01
• Completion: 2020-12-01
• First posted: 2016-07-19
• Last updated: 2018-05-07

Locations

1 site across 1 country: China