A Prospective, Randomized, Two-Cohort, Exploratory Clinical Study of Dalpiciclib Combined With Camrelizumab in Patients With Unresectable Hepatocellular Carcinoma Previously Treated With Immune Checkpoint Inhibitors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
While immune-based therapies (including targeted-immune or dual-immune regimens) have become first-line standard for advanced hepatocellular carcinoma (HCC), there is a lack of high-level evidence to guide second-line treatment after progression on immune checkpoint inhibitors (ICIs).
Preclinical studies suggest synergistic antitumor activity between CDK4/6 inhibitors and PD-1/PD-L1 blockade. However, no clinical studies have yet evaluated the combination of dalpiciclib and camrelizumab in this setting.
To address this unmet need and explore novel second-line strategies for advanced HCC, we plan to conduct an exploratory clinical trial investigating the efficacy and safety of dalpiciclib plus camrelizumab in patients with unresectable HCC previously treated with ICIs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
- •Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
- •Barcelona clinic liver cancer-stage C
- •Patients who have previously received first-line treatment with ICI treatments (including PD-1/PD-L1/CTLA-4) and who have shown tumor progression as confirmed by imaging studies.
- •Eastern Cooperative Oncology Group performance status of 0 to 1
- •No Cirrhosis or cirrhotic status of Child-Pugh class A only
- •Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
- •The following laboratory parameters:
- •Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/L Serum albumin ≥ 30 g/L ASL and AST ≤ 5 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) >1,500/mm3
- •Ability to understand the protocol and to agree to and sign a written informed consent document
排除标准
- •Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
- •Known history of HIV
- •History of organ allograft
- •Known or suspected allergy to the investigational agents or any agent given in association with this trial.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
- •Evidence of bleeding diathesis.
- •Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
- •Known central nervous system tumors including metastatic brain disease
研究组 & 干预措施
High-Dalpiciclib +Camrelizumab
Dalpiciclib 125mg, qd+Camrelizumab 200mg q2w
干预措施: Dalpiciclib Isetionate Tablets (Drug)
High-Dalpiciclib +Camrelizumab
Dalpiciclib 125mg, qd+Camrelizumab 200mg q2w
干预措施: Camrelizumab (anti-PD-1 inhibitor) (Drug)
Low-Dalpiciclib +Camrelizumab
Dalpiciclib 100mg, qd+Camrelizumab 200mg q2w
干预措施: Dalpiciclib Isetionate Tablets (Drug)
Low-Dalpiciclib +Camrelizumab
Dalpiciclib 100mg, qd+Camrelizumab 200mg q2w
干预措施: Camrelizumab (anti-PD-1 inhibitor) (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 6 months
ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all randomized subjects whose best overall response (BOR) is either a CR or PR.
次要结局
- Overall survival (OS)(6 months)
- Progression free survival (PFS)(6 months)
- Adverse events(30 days)
研究者
Shi Ming
Professor
Sun Yat-sen University