[Translation] A randomized, controlled, double-blind, multi-center phase III registration clinical study of recombinant human endostatin injection (Endostat®) combined with cisplatin versus placebo combined with intracavitary cisplatin injection in the treatment of malignant pleural ascites
主要研究目的
与安慰剂联合顺铂腔内注射比较,以无穿刺和/或引流生存期(Puncture /drainage-Free Survival, PuFS)为指标评价恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液的疗效。
次要研究目的
与安慰剂联合顺铂腔内注射比较,以6个月总生存率为指标评价恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液的生存获益(关键次要研究目的);
与安慰剂联合顺铂腔内注射比较,以WHO胸腹腔积液疗效标准评价的胸腹腔积液客观缓解率、3个月无穿刺和/或引流率,至下一次穿刺和/或引流时间(TTNP)、12个月OS率及OS为指标,评价恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液的疗效;
与安慰剂联合顺铂腔内注射比较,以干预前、后患者报告结局(PRO)评分变化评估的恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液对受试者症状及生活质量的变化;
与安慰剂联合顺铂腔内注射比较,评价恩度®联合顺铂腔内注射治疗恶性胸腔或腹腔积液的安全性。
[Translation] Main research purpose
Compared with placebo combined with intracavitary injection of cisplatin, using Puncture/drainage-Free Survival (PuFS) as an index to evaluate the efficacy of Endovir combined with intracavitary cisplatin injection in the treatment of malignant pleural or ascites curative effect.
Secondary research purpose
Compared with placebo combined with intracavitary cisplatin injection, the 6-month overall survival rate was used to evaluate the survival benefit of Endovir combined with intracavitary cisplatin injection in the treatment of malignant pleural or ascites (key secondary research objective);
Compared with placebo combined with intracavitary injection of cisplatin, objective remission rate of pleural effusion, 3-month non-puncture and/or drainage rate, and time to next puncture and/or drainage as assessed by WHO efficacy criteria for pleural ascites ( TTNP), 12-month OS rate and OS were used as indicators to evaluate the efficacy of Endovir combined with intracavitary injection of cisplatin in the treatment of malignant pleural or ascites;
Symptoms and quality of life of patients with malignant pleural or intraperitoneal effusion treated with Endovir combined with cisplatin as assessed by changes in patient-reported outcome (PRO) scores before and after the intervention compared with placebo combined with cisplatin The change;
To evaluate the safety of Endovir combined with intracavitary cisplatin in the treatment of malignant pleural or ascites compared with placebo combined with intracavitary cisplatin.