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

RecruitingPhase 2Ages 18 Years - 80 YearsAllShanghai Jiao Tong University School of Medicine
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 * Life expectancy of more than 18 weeks; * T stage≥ T2 or histopathological lymph node positive according to AJCC (8th edition) staging. * Adequate hepatic, hematologic and renal functions(ALT≤5×upper limit of normal (ULN), AST≤5×ULN, the Child-Pugh classification for class A or B, white blood cells≥3×10\^9/L, neutrophils≥1.5×10\^9/L, platelets≥75×10\^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min; * Volunteer for this study, have written informed consent and have good Patient compliance; * Female patients of childbearing potential and their mates agree to avoid pregnancy. Exclusion Criteria: * 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; * Have uncontrolled diabetes mellitus; * Psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol; * Active autoimmune diseases require long-term use of steroids or received allotransplantation * Other serious illness considered not suitable for this study by investigators.
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What it tests

  • gemcitabine and oxaliplatin.
  • Afatinib
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Where

2 sites
Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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