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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Ruijin Hospital | OTHER |
| RenJi Hospital | OTHER |
| Qilu Hospital of Shandong University |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afatinib with GEMOX | Experimental | 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) |
|
| GEMOX | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gemcitabine and oxaliplatin. | Drug | GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year DFS | 3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT. | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year OS | 3-year Overall survival rates | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| sensitivity and specificity of ctDNA | sensitivity and specificity of ctDNA compared to clinical index(CA199,CEA)for monitoring tumour progression | up to 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yingbin Liu, PHD | Contact | +8613918803900 | laoniulyb@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Yingbin Liu, PHD | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36854604 | Derived | Yang M, Zhao Y, Li Y, Cui X, Liu F, Wu W, Wang XA, Li M, Liu Y, Liu Y. Afatinib in combination with GEMOX chemotherapy as the adjuvant treatment in patients with ErbB pathway mutated, resectable gallbladder cancer: study protocol for a ctDNA-based, multicentre, open-label, randomised, controlled, phase II trial. BMJ Open. 2023 Feb 28;13(2):e061892. doi: 10.1136/bmjopen-2022-061892. |
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| ID | Term |
|---|---|
| D005706 | Gallbladder Neoplasms |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000093542 | Gemcitabine |
| D000077150 | Oxaliplatin |
| D003132 | Commerce |
| D036881 | Long-Term Synaptic Depression |
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Shanghai East Hospital of Tongji University | OTHER |
| Changshu Affiliated Hospital of Soochow University | OTHER |
| Qinghai People's Hospital | OTHER |
| The Second People's Hospital of Baoshan, Yunnan Province | UNKNOWN |
| Lanzhou University Second Hospital | OTHER |
| The Affiliated Hospital of Inner Mongolia Medical University | OTHER |
| The First People's Hospital of Nantong | UNKNOWN |
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| Afatinib | Drug | Target therapy Drug: afatinib |
|
|
| Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | China |
|
| D001660 |
| Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D013676 | Technology, Industry, and Agriculture |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D000577 | Amides |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |