The Efficacy and Safety of Donafenib Plus PD-1/L1 Monoclonal Antibodies Plus Transarterial Chemoembolization (TACE) or Hepatic Arterial Infusion Chemotherapy (HAIC) as First-line Treatment for Unresectable Hepatocellular carcinomaA Multicenter, Retrospective Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- progression free survival(PFS)
研究概览
简要总结
This is a multicenter, retrospective study planned to enroll patients with unresectable hepatocellular carcinoma (uHCC) who received first-line donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC at 8 sites between June 1, 2021 and November 30, 2024. The study consists of two cohorts: Cohort A consists of patients who received donafenib + PD-1/L1 inhibitor + TACE, and Cohort B consists of patients who received donafenib + PD-1/L1 inhibitor + HAIC, with a planned enrollment of 200 patients per cohort. Relevant data will be collected to evaluate the efficacy and safety of donafenib combined with an anti-PD-1/L1 monoclonal antibody and either TACE or HAIC in the treatment of uHCC in real-world clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients with unresectable hepatocellular carcinoma (uHCC) who received donafenib, an anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC), with retrievable records in the hospital electronic information system between June 1, 2021 and November 30,
- •Diagnosis of hepatocellular carcinoma confirmed by the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition) clinically or by histology/cytology.
- •Age ≥18 years, regardless of sex.
- •No prior systemic therapy before the administration of donafenib, anti-PD-1/L1 monoclonal antibody combined with transarterial interventional therapy (TACE or HAIC).
- •The maximum interval between the initiation of donafenib, anti-PD-1/L1 monoclonal antibody, and transarterial interventional therapy (TACE or HAIC) does not exceed 8 weeks, and at the time the last of these treatment modalities is initiated, the subject must not have experienced disease progression.
- •For patients who have previously undergone hepatectomy, the resection must be R0, and tumor recurrence must have occurred more than 24 months after surgery.
- •At least one evaluable lesion (according to RECIST v1.1 criteria).
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to
- •Child-Pugh class A or B.
- •Adequate major organ function, defined by the following criteria:
- •Complete blood count (without blood transfusion or use of granulocyte colony-stimulating factor [G-CSF] within 14 days prior to screening):
- •Hemoglobin ≥90 g/L;
- •Absolute neutrophil count (ANC) ≥1.5×10⁹/L;
- •Platelet count ≥75×10⁹/L;
- •- Blood biochemistry (without albumin use within 14 days prior to screening):
- •Albumin ≥28 g/L;
- •Total bilirubin ≤2× upper limit of normal (ULN);
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5× ULN;
- •Alkaline phosphatase (ALP) ≤5× ULN;
- •Creatinine ≤1.5× ULN;
- •- Coagulation function:
- •International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN;
- •Activated partial thromboplastin time (APTT) ≤1.5× ULN.
排除标准
- •Incomplete or unavailable patient information data; patient refused follow-up or was lost to follow-up;
- •Duration of donafenib, PD-1/L1 monoclonal antibody combined with transarterial intervention therapy was less than 1 month;
- •Prior histologically/cytologically confirmed diagnosis of fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, cholangiocarcinoma, or other components;
- •History of malignancy other than hepatocellular carcinoma, unless meeting the following criteria: a) The patient received potentially curative treatment and there has been no evidence of disease for 5 years; b) Successfully treated resected cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or other carcinoma in situ;
研究组 & 干预措施
Group A
Donafenib +PD-1/L1+TACE
干预措施: PD-1 / PD-L1 monoclonal antibody (Drug)
GROUP B
Donafenib +PD-1/L1+HAIC
干预措施: Donafeinib (Drug)
GROUP B
Donafenib +PD-1/L1+HAIC
干预措施: PD-1 / PD-L1 monoclonal antibody (Drug)
Group A
Donafenib +PD-1/L1+TACE
干预措施: Donafeinib (Drug)
Group A
Donafenib +PD-1/L1+TACE
干预措施: Transcatheter arterial chemoembolization (Procedure)
GROUP B
Donafenib +PD-1/L1+HAIC
干预措施: Hepatic Artery Infusion Chemotherapy (Procedure)
结局指标
主要结局
progression free survival(PFS)
时间窗: Up to approximately 2 year
Progressive disease is measured according to modified Response Evaluation Criteria in Solid Tumors
次要结局
- Objective response rate（ORR）(up to approximately 2 years)
- Disease control rate（DCR）(up to approximately 2 years)
- Overall Survival (OS）(up to approximately 2 years)
- Duration of Response（DOR）(up to approximately 2 years)
- Safety（incidence of AEs ）(up to approximately 2 years)