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The early phase clinical trial has become a key component for successfully developing advanced cancer treatments. The single-arm phase II trial is an initial step to access the primary efficacy of a new agent and drug. Traditional cancer treatments are chemotherapy or radiation or chemotherapy plus radiation. The primary endpoint of cancer clinical trials is tumor response which is often categorized as responder (complete response or partial response) or nonresponder (stable disease or disease progression). However, chemotherapy or radiation has not been successful for treating patients with advanced cancers.
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