A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFudan University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial population
During the whole study period, a total of 750 patients in the selected research centers from December 2024 to December 2025 were planned to be recruited consecutively, including 150 in cohort a, 150 in cohort B, 150 in cohort C, and 300 in cohort D. A single subject was visited every 8 weeks after enrollment until the diagnosis and treatment mode changed, disease progression or the patient withdrew from the study or died for any reason, whichever occurred first. The maximum duration of a single subject's total visit shall not exceed 24 months.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Targeted drugs combined with anti-PD-1/PD-L1 antibodies
DrugTargeted drugs combined with anti-PD-1/PD-L1 antibodies
TACE (transarterial chemoembolization) combined with targeted/immunotherapy
DrugTACE (transarterial chemoembolization) combined with targeted/immunotherapy
Lenvatinib monotherapy
DrugFor 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.
Huaier granules combined with any of the above Cohorts for treatment
DrugOral 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.
Treatment groups
750 Participants
are divided into 4 treatment groupsGroup A: Cohort A1 intervention
Group B: Cohort B1 intervention
Group C: Cohort C1 intervention
Group D: Cohort D1 intervention
Trial outcomes
Primary outcomes
1
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-up2
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-up3
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-up4
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-upSecondary outcomes
1
Quality of Life Score
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-up2
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-up3
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-up4
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-upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fudan University
Lead sponsor
LinkDoc Technology (Beijing) Co. Ltd.
Collaborator
Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov
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