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
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.
Study Type
OBSERVATIONAL
Enrollment
750
Targeted drugs combined with anti-PD-1/PD-L1 antibodies
TACE (transarterial chemoembolization) combined with targeted/immunotherapy
For patients weighing less than 60 kg, the recommended daily dose of this product is 8 mg (2 capsules of 4 mg), once daily; For patients weighing ≥ 60 kg, the recommended daily dose of this product is 12 mg (3 capsules of 4 mg), once daily. Treatment should be continued until disease progression or intolerable toxic reactions occur.
ORRObjective response rate (ORR)
It defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) in primary tumor imaging evaluation.
Time frame: start of treatment until 24-month follow-up
Progression free survival (PFS)
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.
Time frame: Start of treatment until 24-month follow-up
Disease control rate (DCR)
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 frame: Start of treatment until 24-month follow-up
Time to Response（TTR）
It defined as the time from the date the subject first receives combination therapy to the first observation of tumor response (CR or PR).
Time frame: Start of treatment until 24-month follow-up
Duration of Response (DoR)
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.
Time frame: Start of treatment until 24-month follow-up
Overall survival (OS):
It defined as the time from the day of randomization of patients to death from any cause.
Time frame: Start of treatment until 24-month follow-up
Quality of Life Score
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Oral administration of Huaier granules, 10g each time, 3 times a day, until the end of the study, intolerable toxicity, withdrawal from the study for any reason, or death, whichever occurs first; Or the researcher determines that there is no longer any benefit.It is recommended that the date of first use of Huaier granules be determined by the researchers, and after disease progression, the researchers and patients should jointly decide whether to continue receiving Huaier granules treatment.
Evaluation using the EORTC QLQ-C30 (Chinese version) core quality of life scale developed by the European Organization for Cancer Research and Treatment.
Time frame: Start of treatment until 24-month follow-up
The incidence and severity of adverse events (AE) and severe adverse events (SAE)
The definition and severity grading of AE and SAE refer to the corresponding descriptions in the definition and evaluation section of adverse events, and the incidence rate is defined as the proportion of patients with AE and SAE to the corresponding total population.
Time frame: 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)
The definition and severity grading of ADR, severe ADR, and SUSAR refer to the corresponding descriptions in the definition and evaluation section of adverse events. The incidence rate is defined as the proportion of patients with ADR, severe ADR, and SUSAR to the corresponding total population.
Time frame: Start of treatment until 24-month follow-up
The incidence and severity of Adverse Events of Special Concern (AESI)
AESI includes proteinuria, enteritis, and immune-mediated myocarditis. The incidence is defined as the proportion of patients who experience AESI to the corresponding total population, and the severity grading refers to the corresponding description in the definition and evaluation section of adverse events.
Time frame: Start of treatment until 24-month follow-up