irenea........I would like to share this: (I am sure to be corrected if stating anything wrong.) Oftentimes, the criteria are strict: No metastases, limited or, no prior chemotherapy, sometimes no multiple tumors or, sometimes tumors not exceeding a specific size. I have learned about some clinical trials where a controlled group of patients is being treated with a conventional therapy and the results are then compared to the control group receiving another drug or, another drug in addition to the conventional drug. For example: Group A receives 5FU and Leucovarin and Group B receives 5FU, Leucovarin and Oxyplatin. The results are then compared. However, a new drug for Cholangiocarcinoma would fall under the Orphan Drug status meaning: it is a rare disease affecting fewer than 200,000 patients or: less then 5 people per 10,000.
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