NCT05660213

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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 750 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Unresectable Hepatocellular Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-01
• Completion: 2030-08-01
• First posted: 2022-12-21
• Last updated: 2025-05-20