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目的 用131I标记抗癌胚抗原 (CEA)单抗C5 0 ,应用于临床胃肠癌的导向治疗 ,进行Ⅰ期临床研究。方法 对经传统治疗方法无效的 10例胃肠癌病人进行了研究。131I -C5 0剂量组分别为 3 70MBq/m2 ,3 71～ 74 0MBq/m2 ,74 1～ 1110MBq/m2 和 1111～ 2 2 2 0MBq/m2 。给药途经 :腹腔注射 5例 ,肝动脉内注射 3例 ,胃粘膜下注射 1例 ,淋巴结内注射 1例。结果 各组病人的造血系统功能均良好 ,肝肾功能未发生异常改变。药代动力学分析显示131I-C5 0的清除 ,经肝动脉给药组 ,符合两室型数学模型 ;经腹腔给药组 (恶性腹水组 )符合一室一类吸收非线性型数学模型 ;人造腹水组符合一室一类吸收型数学模型。 8例病人作了HAMA动态检测 ,阳性率为 62 5 %。治疗反应完全缓解 (CR) 2例 ,部分缓解 (PR) 5例 ,无改变 (NC) 2例 ,进展 (PD) 1例。 8例血清CEA升高者 ,治疗后有 7例下降 ;4例腹水CEA升高者 ,治疗后有 3例下降。结论 131I -C5 0对肿瘤灶具有良好的导向作用 ,最大用量达2 2 2 0MBq/m2 仍未产生任何毒性反应。用药剂量还可以进一步加大 ,以期取得更好的疗效。
Objective To label anti-carcinoembryonic antigen (CEA) monoclonal antibody C5 0 with 131I for the clinical treatment of gastrointestinal cancer and conduct phase I clinical study. Methods 10 patients with gastrointestinal cancer who were ineffective by traditional treatment methods were studied. The 131I-C50 dose group was 3 70 MBq/m2, 3 71 to 74 0 MBq/m2, 74 1 to 1110 MBq/m2, and 1111 to 2202 MB/m2, respectively. The route of administration was intraperitoneal injection in 5 cases, hepatic artery injection in 3 cases, gastric submucosal injection in 1 case, and lymph node injection in 1 case. Results The function of hematopoietic system was good in all groups, and there was no abnormal change in liver and kidney function. The pharmacokinetic analysis showed that the clearance of 131I-C50 was consistent with a two-compartment model in the hepatic arterial administration group; the intraperitoneal administration group (malignant ascites group) met a one-compartment, one-class, non-linear mathematical model; The ascites group conforms to a one-compartment, one-absorption mathematical model. HAMA detection was performed in 8 patients and the positive rate was 62.5%. The response to treatment was complete remission (CR) in 2 patients, partial remission (PR) in 5 patients, no change (NC) in 2 patients, and progression (PD) in 1 patient. Among 8 patients with elevated serum CEA, 7 patients had decreased after treatment; 4 patients had elevated ascites CEA, and 3 patients had decreased after treatment. Conclusion 131I-C50 has a good guiding effect on tumor foci, and the maximum dosage of 22200MBq/m2 has not produced any toxic reaction. The dosage can also be further increased in order to achieve better results.