NCT06370065招募中2 期
Efficacy and Safety of Serplulimab Combined With Bevacizumab Biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) Patients
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2023年4月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Evaluation of the efficacy and safety of Serplulimab combined with bevacizumab biosimilar and HAIC in Advanced Hepatocellular Carcinoma (HCC) patients
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to attend the study and having given the ICF
- •Have a HCC diagnosis confirmed by radiology, histology, or cytology HCC is diagnosed at Barcelona Clinic Liver Cancer (BCLC) Stage C
- •Have not accepted any of systemic therapy for HCC such as systemic chemotherapy, molecular targeted drugs, immunotherapy.
- •At least 1 measurable intrahepatic lesion suitable for repeat assessments according to RECISTv1.1 criteria and it has not undergone surgery, radiology and/or other regional therapy (including but not limited to radiofrequency ablation, percutaneous ethanol injection, freezing therapy, high intensity focused ultrasound, transcatheter arterial chemoembolization, transcatheter arterial embolization). But if it progressed after the regional therapy, it could be selected as a target lesion. The local regional therapy must be done 4 weeks before randomization and the related AEs must recover to ≤ CTCAE grade
- •Child-Pugh score ≤7
- •Eastern Cooperative Oncology Group (ECOG) 0 or 1
- •Expected life time is over 12 weeks.
- •HBV-DNA < 2000 IU/mL
- •Organs function:
- •Platelet count ≥75×109/L Absolute neutrophil count (ANC) ≥1.5×109 /L White blood cell count ≥3.0×109 /L Haemoglobin ≥9.0 g/dL Serum total bilirubin ≤1.5×ULN ALT ≤5×ULN, and AST ≤5×ULN（ALT ≤3×ULN, and AST ≤3×ULN, if HCV-RNA is detectable） Albumin ≥28 g/L INR ≤1.5×ULN PT ≤1.5×ULN APTT ≤1.5×ULN Creatinine clearance (CL) >50 mL/min or serum creatinine ≤1.5×ULN Urine protein ≤1+ or ≤1.0g/24h
- •Patient is not fertile or willing and able to obey effective contraception
排除标准
- •Known fibrolamellar HCC, sarcomatoid HCC, mixed cholangiocarcinoma and HCC
- •History of hepatic encephalopathy
- •History of GI bleeding within 6 months, or investigator defined with high risk of haemorrhage for esophageal varices
- •With distant metastasis (hilar lymph nodes metastasis is allowed)
- •Co-infection of HBV and HCV
- •History of other malignancy within 5 years except for healed local tumor.
- •History of or plan to accept allogenic organ transplantation
- •Ascites requiring invasive intervention (e.g. paracentesis) to maintain symptomatic control (every month or more often)
- •History of myocardial infarction or unstable angina or uncontrolled arrythmia or stroke or cerebral hemorrhage within 6 months prior to randomization. QTcF value ≥450ms（male）or ≥470ms（female） detected by 12-lead electrocardiogram.
- •New York Heart Association Grade ≥2 congestive heart failure or LVEF <50%
- •Uncontrolled hypertension
- •History of hypertensive crisis or hypertensive encephalopathy
- •Active infection including but not limited to tuberculosis and HIV
- •With interstitial lung disease, lung fibrosis, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia and serious impairment in lung function
- •Active autoimmune disorders except patients with substitutional treatment with thyroid hormone and type I diabetes under treatment with insulin.
- •Receipt of live attenuated vaccine within 28 days prior to randomization
- •Current or prior use of steroids (>10mg/d prednisone) or immunosuppressive medication within 14 days before randomization
- •Significant traumatic injury or major surgical procedure within 28 days prior to randomization
- •Receipt of checkpoint inhibitors or T cell costimulatory drugs
- •Receipt of bevacizumab or its analogues
- •Involved in another clinical trial less than 14 days before randomization
- •Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- •Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control
- •Active bleeding, with history of ≥grade 3 bleeding within 6 months, or ≥grade 2 bleeding within 3 months
- •Use of anti-thrombotics within 5 days prior to randomization
- •In need of NSAIDs for long-term treatment.
- •26.With one of the following diseases within 6 months before randomization:(1) Digestive fistula, perforation and abscess (2) Gastrointestinal obstruction (3) Abdominal infection or inflammation (4) Major vascular disease
- •With severe and green wound, active ulcer or untreated fracture
- •History of drug abuse
- •Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to screen for the study
研究组 & 干预措施
HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04）
Experimental
Procedure: HAIC (Hepatic arterial infusion chemotherapy) Drug: HLX10 (PD-1 antibody) Drug: HLX04 (VEGF antibody) HAIC: FOLFOX, q3w, up to 8 times; HLX10: 4.5mg/kg, iv, q3w, ; HLX04: 10mg/kg, iv, q3w.
干预措施: HAIC+Serplulimab（HLX10）+ Bevacizumab Biosimilar（HLX04） (Drug)
结局指标
主要结局
ORR
时间窗: up to 1year
Defined as proportion of patients who have a best response of CR or PR
次要结局
- PFS(up to 1 year)
- OS(up to 2 years)
研究者
研究点 (1)
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