A Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PM8002 Injection in Combination With Standard Chemotherapy as First Line Therapy in Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 9
- 主要终点
- Objective Response Rate
研究概览
简要总结
This is a multicenter, single-arm, open-label phase II study to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in the first-line treatment of subjects with inoperable HCC.
详细描述
PM8002 is a Bispecific Antibody Targeting PD-L1 and VEGF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in clinical study; fully understand the study and sign informed consent voluntarily; willing to follow and able to complete all test procedures;
- •Male or female aged >= 18 years;
- •HCC diagnosed by pathology or clinical;
- •BCLC stage C or B (unresectable or/and not suitable for local therapy);
- •Child-Pugh score <= 7;
- •ECOG performance status of 0 or 1.
排除标准
- •Histological diagnosis of fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC;
- •Symptomatic CNS metastases, not suitable for the study assessed by investigator;
- •Evidence of major coagulopathy or other obvious risk of bleeding;
- •Unable to accept enhanced imaging examination (CT or MRI) for any reason;
- •History of severe allergic disease, severe allergy to drugs or known allergy to any component of the drug in this study;
- •Human immunodeficiency virus infection or known acquired immunodeficiency syndrome;
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- •Known history of alcohol abuse, psychotropic drug abuse or drug abuse;
- •Patients with psychiatric disorders or poor compliance;
- •Women who are pregnant or breastfeeding;
- •The condition of the subject, as determined by the investigator, may increase the risk of after study treatment, or may cause confusion about the interpretation of the toxic reaction and AE;
- •Other conditions lead to inappropriate to participate in this study as judged by the investigator.
研究组 & 干预措施
PM8002+FOLFOX-4
PM8002 20mg/kg Q2W day 1: oxaliplatin [85 mg/m2, 2-h infusion] plus leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]; day 2: leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]
干预措施: FOLFOX regimen (Drug)
PM8002+FOLFOX-4
PM8002 20mg/kg Q2W day 1: oxaliplatin [85 mg/m2, 2-h infusion] plus leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]; day 2: leucovorin [200 mg/m2, 2-h infusion], followed by 5-fluorouracil [400 mg/m2, intravenous bolus; 600 mg/m2, 22-h infusion]
干预措施: PM8002 (Biological)
结局指标
主要结局
Objective Response Rate
时间窗: Up to approximately 2 years
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
次要结局
未报告次要终点