NCT05660213

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

Not yet recruiting Last updated 15 May 2025

What this trial tests

trial testing Targeted drugs combined with anti-PD-1/PD-L1 antibodies in Unresectable Hepatocellular Carcinoma in 750 participants. Not yet recruiting.

Timeline

1 August 2025

Primary endpoint
1 August 2027

1 August 2030

Quick facts

Lead sponsor	Fudan University
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	750
Start date	1 August 2025
Primary completion	1 August 2027
Estimated completion	1 August 2030

Drugs / interventions tested

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

Conditions studied

• Unresectable Hepatocellular Carcinoma — all drugs for Unresectable Hepatocellular Carcinoma →

Sponsor

Fudan University

Who can join

18 and older, any sex, with Unresectable Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• ORRObjective response rate (ORR)
  Time frame: 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)
  Time frame: 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)
  Time frame: 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）
  Time frame: 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)
  Time frame: 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):
  Time frame: 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.

Sponsor's own description

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

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Traditional Chinese medicine for the treatment of cancers of hepatobiliary system: from clinical evidence to drug discovery.
   Wu J, Tang G, Cheng CS, Yeerken R, et al · · 2024 · cited 34× · PMID 39354529 · DOI 10.1186/s12943-024-02136-2
2. Current Immunotherapy Strategies and Emerging Biomarkers for the Treatment of Hepatocellular Carcinoma.
   Kapelanski-Lamoureux A, Lazaris A, Meti N, Metrakos P. · · 2025 · PMID 41375071 · DOI 10.3390/cancers17233870