The evaluation of the efficacy of Chinese medicine in treating malignant tumors (solid tumors) has always been based on the efficacy evaluation standards of WHO for solid tumors or the Guiding Principles for Clinical Research of New Drugs (Traditional Chinese Medicines). However, the targets of TCM treatment of malignant tumors are mostly patients in middle and late stages, whose treatment is characterized by the combination of disease identification and evidence identification, and the importance of patients’ subjective feelings and clinical benefits, including “survival with tumor”. Therefore, it is difficult for the above criteria to reflect the efficacy of Chinese medicine. It is imperative to establish evaluation standards that appropriately reflect the efficacy of Chinese medicine in tumor treatment. This draft is based on the “Clinical Diagnosis and Efficacy Criteria of Chinese Medicine in Treating Common Malignant Tumors (Part I Discussion Draft)” of the Guizhou Meeting of the Oncology Branch of the Chinese Society of Traditional Chinese Medicine (CSTCM) in 1999, and it has been revised repeatedly after combining with the relevant progress in recent years and listening to the opinions of various parties. It is hoped that it will be gradually modified and improved in the future clinical operation. Based on the considerations of practicality and operability, the evaluation criteria of therapeutic efficacy are as follows: Wang Shumei, Department of Oncology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. Part I: Stage Ⅰ to Ⅱ (Early and Intermediate Stage) Efficacy Evaluation Criteria Total Efficacy Evaluation Criteria (100%) = Tumor Change (40%) + Clinical Symptoms (15%) + Physical Condition (15%) + Survival Period (30%) Apparent Efficacy: 75-100 points, Effective: 50-74 points, Stable: 25-74 points, Stable: 25-74 points, Stable: 25-74 points, Effective: 50-100 points, Effective: 50-100 points, Stable: 25-100 points, Stable: 25-75 points. ～Effective: 75-100 points, Effective: 50-74 points, Stable: 25-49 points, Ineffective: <25 points. 1. Tumor changes (40%) According to the WHO general standard. 40 points, according to the actual score × O.40. CR: complete remission (100 points). PR: partial remission (80 points). MR: Minimal effect (50 points). NC: stable (30 points). PD: Progression (0 points). *The coefficient of 1.2 is multiplied by the coefficient of CR (i.e., 120 points for CR). 2. Clinical symptoms (15%) Symptoms and efficacy scoring criteria. 15 points, according to the actual score × O.15. According to the main symptom performance, after the treatment than before the treatment of two levels of decline, is effective (100 points), down one level, is effective (50 points), there is no change, is stable (25 points), the further development of symptoms, is ineffective (0 points). 3. Physical condition (15%) According to the Karnofsky scale. The score of 15 points was determined by the actual score × O.15. Effective: The physical condition improved by 20 points compared with the pre-drug level (100 points). Effective: Improvement of physical condition by 10 points (50 points). Stable: no significant change in physical condition (25 points). Ineffective: Decrease in physical condition (0 points). 4. Survival (30%) Survival time ≥60 months (more than 5 years), 30 points, according to the actual score × O.3. 1 point is awarded for every 2 months of survival from the date of initiation of treatment, and so on. Part II: Stage III-IV (advanced) efficacy evaluation criteria Total efficacy evaluation criteria (100%) = tumor change (30%) + clinical symptoms (15%) + physical condition (15%) + survival (40%). Significant effect: 75-100 points, effective: 50-74 points, stable: 25-49 points, ineffective: <25 points. Tumor changes, clinical symptoms, and physical status were calculated in the same way as the criteria for evaluating the efficacy of stage I-II (early and intermediate stages). In addition, if the survival period is ≥12 months (more than 1 year), 40 points will be awarded. The actual score × O.4, 10/3 points for each month of survival from the start of treatment, and so on. The total score is rounded up. Note: Symptomatic efficacy scale: 5 points. 1.5 Degree Scoring Method (scored by medical personnel) 0 degree: no obvious symptoms. Degree I: Mild symptoms, tolerated, no treatment required. Degree II: Symptoms are severe, often difficult to tolerate, and must be treated appropriately. Ⅲ: Symptoms are severe and cannot be tolerated, symptomatic treatment is required. IV: Extremely severe, life-threatening symptoms, requiring specific treatment.