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Clinical Trials in China / NCT04183712
Recruiting Phase 2

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

NCT04183712 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Jiao Tong University School of Medicine
Phase
Phase 2
Started
2020-06-01
Last updated
2024-10-16

Condition(s) studied

Gallbladder Carcinoma

Investigational drug(s) / intervention(s)

gemcitabine and oxaliplatin. →Afatinib →

gemcitabine and oxaliplatin.: GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.

Afatinib: Target therapy Drug: afatinib

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Renji hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting

More Shanghai Jiao Tong University School of Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04183712 on ClinicalTrials.gov ↗ ← All trials in China