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Hypothesis: Different patients have different biomarkers, if doctors know about the biomarkers of patients; they may be able to prescribe a regimen that is better suited to the patient's specific needs. This is a pilot study. Here, we used whole exon sequencing and Integrated genomic network analysis to identify the biomarker or gene. We aimed to learn if the drug chosen based on biomarkers can help to control metastatic gastrointestinal cancer who had failed from all standard and available regimens.
Rational: Cancer sequencing (CS) promises to become the centerpiece of personalized oncology by informing on treatments targeted to each tumor's unique genetic constitution. This data can be critical to making an informed decision for disease management, though this may not be the case for all patients. CS identifies variations or differences in the DNA and/or RNA of the cells in an individual's tumor by comparison to that of his/her normal cells. These somatic variations may, on further interpretation, be identified as key drivers of carcinogenesis. Such information may predict a patient's prognosis, response to currently available treatments or prompt the development of novel therapeutics. Though CS has the potential to personalize and optimize cancer care, it may produce a vast amount of data and unique changes in the DNA/RNA that may be difficult to interpret at the present time.
Using the Integrated genomic network analysis, we could have better understanding of the underlying processes and pathways involved in tumor onset and progression. And then we could choose a specific treatment regimen and develop personalized cancer therapies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib or Gefitinib | Experimental | Erlotinib 150 mg tablet or Gefitinib 250 mg tablet by mouth every day |
|
| Everolimus | Experimental | Everolimus 10 mg orally once daily every day |
|
| Imatinib | Experimental | Imatinib 400 mg tablet orally per day |
|
| Sorafenib or Sunitinib | Experimental | Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day |
|
| Vandetanib | Experimental | Vandetanib 300 mg orally once daily |
|
| Control | No Intervention | No intervention was performed for patients without any gene alternation or without any available target agents |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erlotinib or Gefitinib | Drug | Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | From the date of enrollment until the date of death from any cause. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | After identifying the driver gene and choosing the specific target drug, the response rate of all patients. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | The disease control rate of all patients. | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanghong Deng, PhD | Sixth Affiliated Hospital, Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal Hospital, Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510655 | China |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| D000077156 | Gefitinib |
| D000068338 | Everolimus |
| D000068877 | Imatinib Mesylate |
| D000077157 | Sorafenib |
| D000077210 | Sunitinib |
| C452423 | vandetanib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Everolimus | Drug | Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation |
|
|
| Imatinib | Drug | Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation |
|
|
| Sorafenib or Sunitinib | Drug | Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day with or without food for patients with VEGFR, KIT, RAF gene alternation |
|
|
| Vandetanib | Drug | Vandetanib 300 mg orally once daily for patients with RET gene fusion. |
|
|
| D005767 |
| Gastrointestinal Diseases |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D001549 | Benzamides |
| D000577 | Amides |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011743 | Pyrimidines |
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D011725 | Pyridines |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D007211 | Indoles |