NCT04183712

Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA

A Multicentre, Open-label, Randomised, Controlled Study of Target Therapy Based on Tumor Molecular Profiling With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (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 recectable gallbladder carcinoma patients monitored by ctDNA.

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 antitumor agents according to the result of genomic and proteomic profiling and be monitored by circulating tumor DNA(ctDNA).

Conditions

• Gallbladder Carcinoma

Interventions

Type	Name	Description
DRUG	gemcitabine and oxaliplatin.	GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.
DRUG	Afatinib	Target therapy Drug: afatinib

Timeline

• Start date: 2020-06-01
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2019-12-03
• Last updated: 2024-10-16

Locations

2 sites across 1 country: China