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.
Who is this study for? Patients with resectable gallbladder carcinoma
What treatments are being studied? Afatinib
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Renji hospital, Shanghai Jiaotong University School of Medicine
RECRUITING
Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Contact Information
Primary
Yingbin Liu, PHD
laoniulyb@163.com
+8613918803900
Time Frame
Start Date:2020-06-01
Estimated Completion Date:2025-12
Participants
Target number of participants:102
Treatments
Experimental: Afatinib with GEMOX
Patients will receive targeted therapy(Afatinib 40mg orally from day 1 to day 21 combined with GEMOX chemotherapy(gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion)
Active_comparator: GEMOX
Patients will receive conventional GEMOX chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion)
Sponsors
Collaborators: Qilu Hospital of Shandong University, The Affiliated Hospital of Inner Mongolia Medical University, Ruijin Hospital, RenJi Hospital, Qinghai People's Hospital, The Second People's Hospital of Baoshan, Yunnan Province, The First People's Hospital of Nantong, The First Affiliated Hospital of Anhui Medical University, Lanzhou University Second Hospital, Shanghai Zhongshan Hospital, Changshu Affiliated Hospital of Soochow University, Shanghai East Hospital of Tongji University
Leads: Shanghai Jiao Tong University School of Medicine