A Multicenter Registry Study on Stage III Hepatocellular Carcinoma in Unresectable CNLC Liver Cancer

Official title

A Multicenter Registry Study on the Efficacy and Safety of Different Treatment Regimens for Unresectable CNLC Liver Cancer Stage III Hepatocellular Carcinoma

Overview

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

Detailed description

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.

Interventions

• Drug Targeted drugs combined with anti-PD-1/PD-L1 antibodies
  Targeted drugs combined with anti-PD-1/PD-L1 antibodies
• Drug TACE (transarterial chemoembolization) combined with targeted/immunotherapy
  TACE (transarterial chemoembolization) combined with targeted/immunotherapy
• Drug Lenvatinib monotherapy
  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.
• Drug Huaier granules combined with any of the above Cohorts for treatment
  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.

Primary outcome measures

• ORRObjective response rate (ORR) [Time frame: start of treatment until 24-month follow-up]
• Progression free survival (PFS) [Time frame: Start of treatment until 24-month follow-up]
• Disease control rate (DCR) [Time frame: Start of treatment until 24-month follow-up]
• Time to Response（TTR） [Time frame: Start of treatment until 24-month follow-up]
• Duration of Response (DoR) [Time frame: Start of treatment until 24-month follow-up]
• Overall survival (OS): [Time frame: Start of treatment until 24-month follow-up]

Secondary outcome measures (4)

• Quality of Life Score [Time frame: Start of treatment until 24-month follow-up]
• The incidence and severity of adverse events (AE) and severe adverse events (SAE) [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) [Time frame: Start of treatment until 24-month follow-up]
• The incidence and severity of Adverse Events of Special Concern (AESI) [Time frame: Start of treatment until 24-month follow-up]

Eligibility criteria

Inclusion criteria

·≥ 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05660213 · HELICOP

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗