11- cancer therapy evaluation program( c t e p)（11 -癌症治疗评估计划(c t e p)）（9页）.docVIP

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11- cancer therapy evaluation program( c t e p)（11 -癌症治疗评估计划(c t e p)）（9页）.doc

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11- cancer therapy evaluation program( c t e p)（11 -癌症治疗评估计划(c t e p)）（9页）

11. MEASUREMENT OF EFFECT Please provide response criteria. If the criteria for solid tumors below are not applicable, the investigator(s) should provide disease-appropriate criteria (e.g., for specific hematologic malignancies) with references, and all solid tumor criteria should be deleted. 11.1 Antitumor Effect – Solid Tumors For the purposes of this study, patients should be re-evaluated for response every [# of weeks] weeks. In addition to a baseline scan, confirmatory scans should also be obtained [# of weeks] (not less than 4) weeks following initial documentation of objective response. Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) [Eur J Ca 45:228-247, 2009]. Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in the RECIST criteria. 11.1.1 Definitions Please use or modify the following text as appropriate. Evaluable for toxicity. All patients will be evaluable for toxicity from the time of their first treatment with _[Agent Name]_. Evaluable for objective response. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated below. (Note: Patients who exhibit objective disease progression prior to the end of cycle 1 will also be considered evaluable.) Evaluable Non-Target Disease Response. Patients who have lesions present at baseline that are evaluable but do not meet the definitions of measurable disease, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for non-target disease. The response as