RecruitingPhase 2NCT04183712

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.


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

102 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding targeted chemotherapy (GEMOX — gemcitabine + oxaliplatin) after surgery for gallbladder cancer, guided by genetic profiling of the tumor, improves survival in patients whose tumors show specific molecular changes. **You may be eligible if...** - You are Chinese and have been diagnosed with gallbladder carcinoma that was surgically removed - Your tumor has specific genetic mutations in the ERBB2 signaling pathway (identified by tumor sequencing) - You are in good physical condition (ECOG 0–1) - You have enough fresh tumor tissue available for genetic testing **You may NOT be eligible if...** - Your cancer is not resectable (surgically removable) - You do not have the required gene mutations - You have severe organ dysfunction or poor overall health - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGgemcitabine and oxaliplatin.

GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.

DRUGAfatinib

Target therapy Drug: afatinib


Locations(2)

Renji hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT04183712


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