A Multicenter Registry Study on the Efficacy and Safety of Different Treatment Regimens for Unresectable CNLC Liver Cancer Stage III Hepatocellular Carcinoma
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 750
- 主要终点
- ORRObjective response rate (ORR)
研究概览
简要总结
This study is a multicenter, registered research aimed at evaluating the efficacy of different treatment regimens in the treatment of unresectable CNLC liver cancer stage III hepatocellular carcinoma
详细描述
This study is a multicenter, observational, natural cohort registration study. We plan to continuously include 750 subjects diagnosed with unresectable CNLC stage III hepatocellular carcinoma (HCC) at selected research centers. According to the actual clinical diagnosis and treatment plan of patients, the following treatment modes will be included in the Cohort of patients:
Cohort A: Targeted drugs combined with anti-PD-1/PD-L1 antibodies Cohort B: TACE (transarterial chemoembolization) combined with targeted/immunotherapy Cohort C: Lenvatinib monotherapy Cohort D: Huaier granules combined with any of the above Cohorts for treatment Throughout the entire study period, it is planned to recruit patients who have visited the selected research center within 12 months (December 2024 to December 2025). Each individual subject will be followed up every 8 weeks until the diagnosis and treatment mode changes, disease progression progresses, or the patient withdraws from the study or dies for any reason, whichever occurs first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •·≥ 18 years old;
- •Diagnosed as unresectable hepatocellular carcinoma through histopathological and/or cytological examination, or meeting the clinical diagnostic criteria for hepatocellular carcinoma in the 2022 edition of the guidelines for the diagnosis and treatment of primary liver cancer;
- •CNLC liver cancer stage III;
- •Liver function Child Pugh A or B grade 7 points;
- •Has not received systematic treatment in the past;
- •Patients with active HBV infection who meet one of the following conditions can be enrolled: ① Within 28 days before enrollment, the patient's HBV DNA is less than 500 IU/mL. If they have received anti HBV treatment, they need to continue their original antiviral treatment; If anti HBV treatment has not been received, it is necessary to receive anti HBV treatment throughout the entire course of medication (according to local treatment standards; for example, entecavir); ② For patients with HBV DNA>500 IU/mL and who have not received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Before enrollment, the serum HBV-DNA virus should be retested to decrease by more than 1 log value For patients with HBV DNA>500 IU/mL and who have received antiviral therapy, they must receive at least 7 days of antiviral therapy (according to local treatment standards; for example, entecavir) before enrollment in this study, and are willing to continue receiving antiviral therapy during the study. Serum HBV-DNA virus levels should be retested before enrollment;
- •Active HCV infected individuals with stable disease status after treatment;
- •At least one tumor lesion available for evaluation;
- •Clear consciousness, language expression ability or reading ability, able to communicate normally, and cooperate to complete the questionnaire evaluation;
- •Voluntarily join this study and sign an informed consent form.
排除标准
- •Simultaneously having two or more active primary malignant tumors;
- •Portal vein cancer thrombus invades the superior mesenteric vein;
- •Received radiation therapy within the past 4 weeks;
- •Expected survival time is less than 3 months;
- •Pregnant or lactating women or those planning to conceive;
- •Coagulation dysfunction (INR>2.0, PT>16 s) or diseases with a strong likelihood of bleeding (including but not limited to esophageal and/or gastric variceal bleeding, active ulcers, uncontrolled hypertension);
- •Refusing to cooperate with follow-up visits;
- •Other reasons led the researchers to believe that it was not suitable to participate in this study.
研究组 & 干预措施
Cohort A
Targeted drugs combined with anti-PD-1 / PD-L1 antibodies
干预措施: Targeted drugs combined with anti-PD-1/PD-L1 antibodies (Drug)
Cohort B
TACE (transarterial chemoembolization) combined with target immunotherapy
干预措施: TACE (transarterial chemoembolization) combined with targeted/immunotherapy (Drug)
Cohort C
Lenvatinib monotherapy
干预措施: Lenvatinib monotherapy (Drug)
Cohort D
Huaier granules combined with any of the above Cohorts for treatment
干预措施: Huaier granules combined with any of the above Cohorts for treatment (Drug)
结局指标
主要结局
ORRObjective response rate (ORR)
时间窗: start of treatment until 24-month follow-up
It defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) in primary tumor imaging evaluation.
Progression free survival (PFS)
时间窗: Start of treatment until 24-month follow-up
It defined as the time from the date the subject first receives combination therapy until the first observation of tumor progression or death from any cause.
Disease control rate (DCR)
时间窗: Start of treatment until 24-month follow-up
It defined as the proportion of subjects who achieve complete response (CR), partial response (PR), or disease stability (SD) as assessed by primary tumor imaging.
Time to Response（TTR）
时间窗: Start of treatment until 24-month follow-up
It defined as the time from the date the subject first receives combination therapy to the first observation of tumor response (CR or PR).
Duration of Response (DoR)
时间窗: Start of treatment until 24-month follow-up
It defined as the time from the first observation of tumor remission (CR or PR) in a subject receiving combination therapy to the first observation of tumor progression or death from any cause.
Overall survival (OS):
时间窗: Start of treatment until 24-month follow-up
It defined as the time from the day of randomization of patients to death from any cause.
次要结局
- Quality of Life Score(Start of treatment until 24-month follow-up)
- The incidence and severity of adverse events (AE) and severe adverse events (SAE)(Start of treatment until 24-month follow-up)
- The incidence and severity of adverse reactions (ADR), severe adverse reactions (SADR), suspicious and unexpected severe adverse reactions (SUSAR)(Start of treatment until 24-month follow-up)
- The incidence and severity of Adverse Events of Special Concern (AESI)(Start of treatment until 24-month follow-up)