Actively Recruiting
Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA
Led by Shanghai Jiao Tong University School of Medicine · Updated on 2024-10-16
102
Participants Needed
2
Research Sites
287 weeks
Total Duration
On this page
Sponsors
S
Shanghai Jiao Tong University School of Medicine
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese ethnicity
- Stable vital signs with ECOG performance status 0-1
- Diagnosed with resectable gallbladder carcinoma by histopathology or cytopathology after radical surgery
- Adequate fresh tumor tissue available for genome sequencing and immunohistochemistry
- Tumor harbors mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components
- Life expectancy of more than 18 weeks
- Tumor stage T2 or higher, or positive lymph nodes according to AJCC 8th edition staging
- Adequate liver, blood, and kidney function (ALT and AST ≤ 5 times upper limit of normal; Child-Pugh class A or B; white blood cells ≥ 3 × 10^9/L; neutrophils ≥ 1.5 × 10^9/L; platelets ≥ 75 × 10^9/L; hemoglobin ≥ 90 g/L; creatinine clearance rate ≥ 60 ml/min)
- Voluntary participation with written informed consent and good compliance
- Female patients of childbearing potential and their partners agree to avoid pregnancy
You will not qualify if you...
- Previous treatment with anti-tumor molecular targeted therapy or chemotherapy within 6 months
- Previous irradiation treatment of lesions
- Participation in other therapeutic or interventional clinical trials
- History of other malignancies except carcinoma in situ of uterine cervix, cured basal cell carcinoma of skin, or other malignancies cured for more than 5 years
- Serious concurrent illnesses including uncontrolled congestive heart failure (NYHA class III or IV), unstable angina, unstable cardiac arrhythmias, uncontrolled moderate or severe hypertension
- Active or ongoing serious infections
- Uncontrolled diabetes mellitus
- Psychiatric illness affecting ability to consent or comply with study
- Active autoimmune diseases requiring long-term steroids or history of allotransplantation
- Other serious illnesses deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Renji hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
2
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yingbin Liu, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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