目的 :评价国产抗癌新药阿托氟啶 (atofluding ,ATFU)对胃癌、食管癌、大肠癌及肝癌的临床疗效、不良反应及对免疫功能的影响。方法 :单药组采用开放非随机试验 ,联合治疗组中心内配对随机对照。单药组给予ATFU 75 0mg·m- 2 ·d- 1 ,分 3次口服 ,连用 4～ 8周 ,第 4周结束时评价疗效。联合治疗给予化疗药加ATFU (治疗组 )或替加氟 (FT 2 0 7,对照组 ) ,均 5 0 0mg·m- 2 ·d- 1 ,分 4次口服 ,连用 2周 ,2组同一类型肿瘤联合用化疗药物相同 ,均每 3周为 1周期 ,连用 2～ 3周期 ,从第 2周期始 ,每周期前评价疗效。以上治疗达CR ,PR ,NC者继续用药至8周 (单药组 )或 3周期 (联合化疗组 )停药。结果 :入组 2 4例患者有 2 3例可评价疗效。接受ATFU治疗的患者有3例 (单药组 1例 ,治疗组 2例 )达PR ,总有效率 15 % ,其中单药组和治疗组有效率分别为 12 .5 %和 16 .7% ;对照组3例中无有效病例。疗前疗后免疫学指标测定表明 ,ATFU对免疫功能无影响或有所改善。ATFU血液学毒性轻微 ,均为I度 ;非血液学不良反应主要表现为恶心、呕吐、腹泻、脱发、粘膜炎、肝功损害 ,多为I度。结论 :国产抗癌新药ATFU对胃癌、食管癌均有一定疗效 ,不良反应轻微 ,无免疫抑制作用 ,是一有价值及治疗前景的抗癌新药。 Objective: To evaluate the clinical efficacy, adverse reactions and immune function of domestic anti-cancer drug ATFU on gastric cancer, esophageal cancer, colorectal cancer and liver cancer. Methods: A single non-randomized open-label group was used in the study. Randomized controls were matched in the center of the combined treatment group. The single drug group was given ATFU 75 0mg · m-2 · d-1, orally 3 times, once every 4 to 8 weeks, the end of the 4th week to evaluate the efficacy. The combination therapy was given chemotherapy drugs ATFU (treatment group) or tegafur (FT 2 0 7, control group), were 500 mg · m-2 · d-1, 4 times orally for 2 weeks, 2 groups of the same Type of tumor combined with chemotherapy drugs are the same, every 3 weeks for 1 cycle, once every 2 to 3 cycles, beginning from the second cycle, the efficacy evaluation before each cycle. The above treatment up to CR, PR, NC continued treatment to 8 weeks (single drug group) or 3 cycles (combined chemotherapy group) withdrawal. Results: Twenty-three patients in 24 patients could evaluate the curative effect. Among the patients receiving ATFU treatment, 3 patients (1 in the single drug group and 2 in the treatment group) reached PR with a total effective rate of 15%. The effective rates in the single drug group and the treatment group were 12.5% ​​and 16.7%, respectively. 3 cases in the control group no effective cases. Immunological indicators before treatment after treatment showed that ATFU had no effect on immune function or improved. ATFU hematology toxicity is mild, are I degrees; non-hematological adverse reactions mainly as nausea, vomiting, diarrhea, hair loss, mucositis, liver damage, mostly I degrees. Conclusion: The domestic anti-cancer drug ATFU has a certain effect on gastric cancer and esophageal cancer with mild adverse reactions and no immunosuppressive effect. It is a new anticancer drug with potential and therapeutic prospects.