目的 既往研究证实从天然植物中提取的化合物 JC724 与 5-Fu 类药物联合使用具有协同抗癌效应。本研究观察JC724 联合卡培他滨治疗胰腺癌、结直肠癌等晚期肿瘤的临床效果和副作用,确定 JC724 治疗晚期肿瘤的剂量和安全性。方法 符合卡培他滨口服化疗的 35 例晚期结直肠癌、胰腺癌等肿瘤患者,采用 JC724 联合卡培他滨治疗,卡培他滨 2,500mg/m2
,口服,每日 2 次,共 14 天,休息 7 天,21 天为一周期;JC724 同步口服,剂量为 800mg、1,000mg、1,200mg
三组,每日 2 次。评价指标为治疗期间肿瘤体积的变化和患者对治疗的耐受性。结果 35 位患者中,男 21 例,女 14 例,平均年龄 62.3 岁,胰腺癌 3 例,结直肠癌 18 例,原发性肝癌 3 例,胆管癌 1 例,胃癌 7 例,乳腺癌 2 例,不明来源肝转移性癌 1 例,ECOG 评分:0~1 分 30 例,2 分 5 例,所有患者共完成 132 个周期卡培他滨治疗(平均 3.77 周期,1~6 周期),JC724 共服药物 134 个周期(平均 3.83 周期,1~6 周期)。1,200mg 组出现 DLT,800mg、1,000mg JC724 均未出现 DLT,我们将联合用药的 JC724 最大剂量定在 1,000mg,3 位患者出现 PR,20 位患者出现持续 8 周以上的 SD。结论 JC724 联合卡培他滨治疗晚期结直肠癌等肿瘤患者能获得较好的疗效,在该方案中,JC724 1,000mg 口服,每日 2 次,1~14 天,安全有效,仍需要进一步研究。
Abstract
Objective Cell experiment showed that the combined use of JC724 extracted from natural plant compounds and 5-Fu had a synergistic antitumor effect. The clinical effects and side effects of JC724 combined with capecitabine in the treatment of pancreatic cancer, colorectal cancer and other advanced cancer were observed, and the dose and safety of JC724 in the treatment of advanced tumors were determined. Methods 35 patients with advanced colorectal cancer, pancreatic cancer and other tumors were treated using JC724 combined with capecitabine. Capecitabine was administered orally at a dose of 1,250 mg/m2 twice daily for 14 days followed by 7 days of rest (one cycle), and JC724 was administered 2 times a day in three different oral doses, 800mg, 1,000mg and 1,200mg. The evaluation indexes were tumor response and patient’s tolerance to the treatment. Results Totally 35 advanced cancer patients were 21 males, 14 females, with the average age of 62.3 years, 3 cases of pancreatic carcinoma, 18 cases of colorectal cancer, 3 cases of primary liver cancer, 1 cases of bile duct cancer, 7 cases of gastric cancer, 2 cases of breast cancer, 1 cases of metastatic liver cancer with unknown origin. The ECOG score of 0~1 in 30 cases, 2 points in 5 cases. All patients completed 132 cycles of capecitabine in the treatment (median 3.77 cycle, 1~6 cycle), and 134 cycles JC724 (median 3.83 cycles, 1~6 cycles ). Only one DLT was observed in 1,200mg group, which 1,000mg would be determined as the maximum dose of JC724. 3 patients had PR, 20 patients had SD for more than 8 weeks. Conclusions JC724 combined with capecitabine in the treatment of advanced cancer patients could obtain better curative effect, in which oral dose of JC724 1,000mg, 2 times a day for up to 1~14 days, was safe and effective, but further research was needed.
关键词
晚期肿瘤 /
中药 /
JC724 /
辅助治疗 /
临床试验研究
Key words
Advanced cancer /
Chinese medicine /
JC724 /
Auxiliary treatment /
Clinical trial