▎ 摘　　要

NOVELTY - Performing a clinical trial for a cancer therapy regimen involves administering a first cancer therapy regimen to a first group of patients having a cancer, determining the therapeutic efficacy offirst cancer therapy regimen for patients in the first group of patients by a method, comprising measuring a nucleic acid marker of cancer burden in a biological sample from the patients. The first cancer therapy regimen is identified as being efficacious in a patient when the nucleic acid marker indicates a lower cancer burden or a stable cancer burden as compared to one or more prior measurements of the nucleic acid marker in that patient after onset of the first cancer therapy regimen, or one or more measurements ofnucleic acid marker in that patient prior to onset of the first cancer therapy regimen, and where the first cancer therapy regimen is identified as not being efficacious in a patient. USE - Method for performing a clinical trial for a cancer therapy regimen, for evaluating a hospice patient, and a cancer patient, where cancer is selected from e.g. head and neck cancer, a central nervous system cancer, a lung cancer, a bronchial cancer, a mesothelioma, an esophageal cancer, a gastric cancer, a gall bladder cancer, a liver cancer, a pancreatic cancer, a melanoma, an ovarian cancer, a small intestine cancer, a colorectal cancer, a breast cancer, a kidney cancer, a renal pelvis cancer, a bladder cancer, a uterine cancer, a cervical cancer, a thyroid cancer (all claimed). ADVANTAGE - The method in contrast to conventional process such as imaging-based methods, the therapeutic efficacy of a cancer therapy regimen can advantageously be determined at an early stage after onset of cancer therapy regimen, and allow approval of temporally complex and variable protocols that involve a new drug. DETAILED DESCRIPTION - Performing a clinical trial for a cancer therapy regimen involves administering a first cancer therapy regimen to a first group of patients having a cancer, determining the therapeutic efficacy offirst cancer therapy regimen for patients in the first group of patients by a method, comprising measuring a nucleic acid marker of cancer burden in a biological sample from the patients. The first cancer therapy regimen is identified as being efficacious in a patient when the nucleic acid marker indicates a lower cancer burden or a stable cancer burden as compared to one or more prior measurements of the nucleic acid marker in that patient after onset of the first cancer therapy regimen, or one or more measurements ofnucleic acid marker in that patient prior to onset of the first cancer therapy regimen, and where the first cancer therapy regimen is identified as not being efficacious in a patient when the nucleic acid marker indicates a higher cancer burden as compared to one or more prior measurements of the nucleic acid marker in that patient after onset ofcancer therapy regimen, or one or more measurements of the nucleic acid marker in that patient prior to onset of the first cancer therapy regimen. The first cancer therapy regimen is continued to administer to a patient when the first cancer therapy regimen is identified as being efficacious in that patient, and discontinuing the first cancer therapy regimen and beginning to administer a second cancer therapy regimen to a patient when the first cancer therapy regimen is identified as not being efficacious in that patient, but retaining the patients receiving the second cancer therapy regimen in the first group of patients. INDEPENDENT CLAIMS are included for the following: (1) the method for performing an early stage clinical trial, which involves administering a first dose level of a first cancer therapy regimen to a first group of patients, determining the therapeutic efficacy of the dose level for patients in the first group of patients by a method, comprising measuring a nucleic acid marker of cancer burden in a biological sample from the patients, where the dose level is identified as being efficacious in a patient when the nucleic acid marker indicates a lower cancer burden or a stable cancer burden as compared to one or more prior measurements of the nucleic acid marker in that patient after onset of the first cancer therapy regimen or one or more measurements ofnucleic acid marker in that patient prior to onset of the first cancer therapy regimen, and where the dose level is identified as not being efficacious in a patient when the nucleic acid marker indicates a higher cancer burden as compared to one or more prior measurements of the nucleic acid marker in that patient after onset ofcancer therapy regimen or one or more measurements of the nucleic acid marker in that patient prior to onset of the first cancer therapy regimen, continuing to administer the first dose level to a patient when the first cancer therapy regimen is identified as being efficacious in the patient, and discontinuing the patient from the trial or escalating that patient to a higher dose level if the first dose level is identified as not being efficacious; (2) the method for evaluating a hospice patient, which involves administering a cancer therapy regimen to a hospice patient, determining the therapeutic efficacy ofcancer therapy regimen in the hospice patient by a method comprising measuring a nucleic acid marker of cancer burden in a biological sample from the patient, and continuing to administer the cancer therapy regimen to the patient when the cancer therapy regimen is identified as being efficacious in the patient, and discontinuing the cancer therapy regimen when the cancer therapy regimen is identified as not being efficacious in the patient; and (3) the method for evaluating a cancer patient to be given a cancer drug therapy that might cause hyperprogression, which involves determining the rate of growth of the patient s cancer by performing at least 2 measurements of circulating DNA prior to beginning of the therapy, determining the rate of growth of the patient s cancer by performing at least 1 measurement of circulating DNA after beginning the therapy, continuing to administer the therapy if the rate of growth has not increased, or discontinuing the therapy if the growth rate has increased.