Target Therapy With GEMOX in Recectable Gallbladder Carcinoma Patients Monitored by ctDNA
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. immuno-histochemistry tests reveal the abnormal activation status of signal pathways involved in study. These information will be used to recommend target therapy which may be more likely to result in a beneficial response. Patients will receive target antitumor agents according to the result of genomic and proteomic profiling and be monitored by circulating tumor DNA(ctDNA).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: target therapy with GEMOX Target therapy |
Drug: Afatinib
Target therapy Drug: afatinib
|
| Active Comparator: conventional chemotherapy The patients wil receive conventional chemotherapy(GEMOX). |
Drug: gemcitabine and oxaliplatin.
GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.
|
Outcome Measures
Primary Outcome Measures
- 3-year DFS [up to 3 years]
3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.
Secondary Outcome Measures
- 3-year OS [up to 3 years]
3-year Overall survival rates
Other Outcome Measures
- sensitivity and specificity of ctDNA [up to 2 years]
sensitivity and specificity of ctDNA compared to clinical index（CA199，CEA）for monitoring tumour progression
Eligibility Criteria
Criteria
Inclusion Criteria:
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Chinese#
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Stable vital signs, ECOG:0-1;
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Patients have a diagnosis of resectable gallbladder carcinoma by histopathology or cytopathology after radical surgery.
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Adequate fresh tumor tissue for genome sequencing and immunohistochemistry test; harboring mutations or abnormal activation of erb-b2 receptor tyrosine kinase signal pathway components
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Life expectancy of more than 18 weeks;
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T stage≥ T2 or histopathological lymph node positive according to AJCC (8th edition) staging.
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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≥3×109/L, neutrophils≥1.5×109/L, platelets≥75×10^9/L , hemoglobin ≥ 90g/L, creatinine clearance rate≥60ml/min;
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Volunteer for this study, have written informed consent and have good Patient compliance;
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Female patients of childbearing potential and their mates agree to avoid pregnancy.
Exclusion Criteria:
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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.
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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;
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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);
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Have ongoing or active serious infection;
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Have uncontrolled diabetes mellitus;
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Psychiatric illness which potentially hamper the ability to willingly give written informed consent and compliance with the study protocol;
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Active autoimmune diseases require long-term use of steroids or received allotransplantation
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Other serious illness considered not suitable for this study by investigators.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Renji hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai | China | |
| 2 | Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Shanghai Jiao Tong University School of Medicine
- Shanghai Zhongshan Hospital
- Ruijin Hospital
- RenJi Hospital
Investigators
- Principal Investigator: Yingbin Liu, PHD, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LTGBCLYB2019