A Single-center Exploratory Clinical Study of Chemotherapy With the Ralox Regimen Combined With Anlotinib and Penpulimab for Unresectable Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
The objective of this clinical trial study is to determine whether intravenous chemotherapy with the Ralox regimen in combination with Anlotinib and Penpulimab has certain efficacy and high safety for patients with unresectable hepatocellular carcinoma.
Overall design: This clinical study is a single - center, single - arm, prospective clinical study.
In this single - arm study, randomization grouping is not involved. Sample size estimation: According to previous research reports, the objective response rate (ORR0) of targeted immunotherapy for literature unresectable HCC is 30%. If α = 0.05 and 1 - β = 0.80 are set, and assuming that the ORR1 of systemic chemotherapy combined with targeted immunotherapy for unresectable HCC is 59.2%, at least 21 patients need to be enrolled as calculated by the PASS15.0 software. Considering a 10% dropout rate, 24 patients need to be enrolled. It is planned to enroll a total of 30 patients.
Subjects will receive systemic intravenous chemotherapy combined with immune checkpoint inhibitors and targeted drug therapy:
The intravenous chemotherapy regimen is as follows: Oxaliplatin 100 mg/m², intravenous infusion for 3 hours on Day 1, once every 3 weeks; Raltitrexed 3 mg/m², intravenous infusion for 15 minutes on Day 1.
Penpulimab 200 mg, once every 3 weeks. Anlotinib 12 mg, taken orally once a day, with 2 weeks of administration followed by 1 week of discontinuation.
Each cycle is 21 days. The combined medication will be continued for 3 cycles, or until obvious disease progression, patient intolerance, or until the researcher deems it necessary to stop the medication (whichever occurs first). After that, subsequent treatment will be carried out according to the clinical diagnosis and treatment routine based on the tumor situation.
For each subject, safety assessment and research compliance assessment will be conducted at the first dose and at Weeks 1, 2, and 3 of treatment, and the researcher will medication provide guidance. An examination will be conducted once at the screening visit, every 6 weeks during the treatment phase, and at each research visit during the follow - up period. Throughout the entire research process, its toxicity and safety will be monitored.
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
- •Adult males or females;
- •Meeting the relevant criteria in the "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition)", and diagnosed with HCC through examinations such as ultrasound, enhanced CT and, magnetic resonance imaging, liver puncture biopsy;
- •Patients with unresectable HCC (patients with recurrence after radical resection are eligible for enrollment);
- •ECOG PS score ≤ 2;
- •Liver function of Child-Pugh class A/B, and liver function reserve ICG ≤ 30%;
- •According to the mRECIST criteria for tumor assessment, having ≥ 1 measurable intrahepatic target lesion, and the estimated survival period ≥ 6 months;
- •Normal organ and bone marrow functions before randomization, including: hemoglobin ≥ 90 g/L, absolute neutrophil count ≥ 1.0 × 10^9/L, platelet count ≥ 75 × 10^9/L, total bilirubin ≤ 2.0 × the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 × ULN, albumin ≥ 28 g/L, international normalized ratio PT-INR ≤ 1.6, glomerular filtration rate (DCK-EPI formula) ≥ 50 mL/min, urine protein < 2+ or 24 - hour urine protein quantification < 1.0 g;
- •Those who voluntarily sign the informed consent form.
排除标准
- •Patients with obvious abnormalities in organ and bone marrow functions that are difficult to reverse before randomization, including: hemoglobin < 90 g/L, absolute neutrophil count < 1.0 × 10^9/L, platelet count < 75 × 10^9/L, total bilirubin > 2.0 × the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 5 × ULN, albumin < 28 g/L, international normalized ratio PT - INR > 1.6, glomerular filtration rate (CKD - EPI formula) < 30 mL/min, urine protein ≥ 2+ or 24 - hour urine protein quantification ≥ 1.0 g.
- •Patients with infection, bleeding tendency, massive ascites and hepatic encephalopathy.
- •Patients who have been using hepatotoxic drugs for a long - term due to their own diseases and cannot stop taking the drugs.
- •Patients who have previously received chemotherapy, radiotherapy, immunotherapy or targeted therapy.
- •Patients with other severe diseases of the heart, brain, kidneys and other organs, autoimmune diseases, or diseases such as HIV/tuberculosis that the researcher deems inappropriate for enrollment.
- •Patients who fail to complete the treatment cycle before tumor assessment after the first treatment.
- •Patients with incomplete clinical general data or imaging data.
- •Patients who are currently participating in other therapeutic studies.
研究组 & 干预措施
Group of patients with unresectable hepatocellular carcinoma
干预措施: Intravenous chemotherapy with the Ralox regimen combined with Anlotinib and Penpulimab (Drug)
结局指标
主要结局
ORR
时间窗: through study completion.Continuously follow up the patient's subsequent treatment and survival status，an average of 1 year
ORR = (Number of CR cases + Number of PR cases) / Total number of cases
次要结局
- Conduct imaging evaluation(Evaluate the efficacy of solid tumor treatment according to the criteria established by mRECIST1.1 at the 6th and 12th weeks of the patient's treatment.)
- DCR(through study completion.Continuously follow up the patient's subsequent treatment and survival status，an average of 1 year)
- Incidence of adverse events(During anti - tumor treatment)