About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Chinese#
Stable vital signs, ECOG:0-1;
Patients have a diagnosis of resectable gallbladder carcinoma by histopathology or cytopathology after radical surgery.
Adequate fresh tumor tissue for genome sequencing and immunohistochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components
Disqualifiers
Have received following treatment before this study: a. Anti-tumor molecular target therapy; anti-tumor chemotherapy in 6 months; b. lesions have been treated by irradiation; c. participate in other therapeutic or interventional clinical trials.
History of other malignancies except carcinoma in-situ of uterine cervix, cured basal cell carcinoma of skin and other malignancies for more than 5 years;
Have serious concurrent illness including, but not limited to uncontrolled congestive heart failure(NYHA classification grade III or IV), unstable angina pectoris, unstable cardiac arrhythmias, uncontrolled moderate or serious hypertension(systolic blood pressure >21.3 Kpa or diastolic blood pressure >13.3 Kpa);
Have ongoing or active serious infection;
Trial design
Parallel
Treatments tested in this trial
gemcitabine and oxaliplatin.
DrugGEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.
Afatinib
DrugTarget therapy Drug: afatinib
Treatment groups
Trial outcomes
Primary outcomes
3-year DFS
3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.
Secondary outcomes
3-year OS
3-year Overall survival rates
Other outcomes
sensitivity and specificity of ctDNA
sensitivity and specificity of ctDNA compared to clinical index(CA199,CEA)for monitoring tumour progression
Sponsors and contacts
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Shanghai Jiao Tong University School of Medicine
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Ruijin Hospital
Collaborator
RenJi Hospital
Collaborator
Qilu Hospital of Shandong University
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Shanghai East Hospital of Tongji University
Collaborator
Changshu Affiliated Hospital of Soochow University
Collaborator
Qinghai People's Hospital
Collaborator
The Second People's Hospital of Baoshan, Yunnan Province
Collaborator
Lanzhou University Second Hospital
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
The First People's Hospital of Nantong
Collaborator