NCT07078292

The Efficacy and Safety of First-line Treatment Combined With Immunotherapy for Advanced Hepatocellular Carcinoma: a Single Center, Real-world Study

Not yet recruiting Last updated 22 July 2025

What this trial tests

trial in Hepatocellular Carcinoma (HCC) in 400 participants. Not yet recruiting.

Timeline

1 August 2025

Primary endpoint
31 March 2027

31 December 2027

Quick facts

Lead sponsor	Tianjin Medical University Cancer Institute and Hospital
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	400
Start date	1 August 2025
Primary completion	31 March 2027
Estimated completion	31 December 2027

Conditions studied

• Hepatocellular Carcinoma (HCC) — all drugs for Hepatocellular Carcinoma (HCC) →
• Real World Study — all drugs for Real World Study →

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Who can join

18 and older, any sex, with Hepatocellular Carcinoma (HCC) or Real World Study. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In recent years, immunotherapy represented by PD-1/PD-L1 inhibitors has continuously brought breakthroughs in the treatment of hepatocellular carcinoma and has gradually become the cornerstone of advanced liver cancer treatment. With positive results from the IMbrave-150 study, the combination of atezolizumab and bevacizumab has been approved for first-line treatment of advanced HCC. Subsequently, multiple immune combination therapy regimens were approved one after another, enriching the first-line treatment options for advanced HCC. At present, combination therapy based on immune checkpoint inhibitors has become the mainstream first-line treatment for advanced HCC, and three main treatment modes have been formed: immune combined with bevacizumab, immune combined with TKI, and immune combined with immunity.

Multiple immune combination therapy regimens have shown a flourishing trend in clinical trials, which has brought some thought-provoking issues to the clinical practice of first-line treatment for advanced HCC. On the one hand, the above studies all used sorafenib/lenvatinib monotherapy as a control, lacking a "head to head" comparison. In real-world scenarios, how to choose between different treatment options depends on the judgment of clinical doctors and drug accessibility, lacking support from research data. On the other hand, the ORR of immune combination therapy is between 20% and 40%, and there are still a large number of patients who have initial treatment resistance to the above regimen and cannot achieve satisfactory therapeutic effects. How to accurately predict/identify the response of different populations to different treatment regimens, and then carry out personalized treatment, is also an important issue facing the first-line treatment of advanced HCC. In addition to systemic anti-tumor therapy, local treatment (such as TACE, HAIC, ablation, radiotherapy, etc.) and surgical treatment are also advantageous weapons for treating advanced HCC, complementing systemic treatment to further improve the prognosis of advanced HCC. However, more clinical research evidence is still needed to support the clinical efficacy data of local treatment combined with systemic treatment in the field of advanced HCC treatment.

Based on the above clinical issues, this study intends to retrospectively and prospectively collect advanced HCC patients who receive first-line immunotherapy in our center, explore the effectiveness and safety of combination therapy based on immune checkpoint inhibitors for first-line treatment of advanced hepatocellular carcinoma in the real world, and reveal the advantageous treatment populations of different immunotherapy regimens (immune+bevacizumab, immune+TKI, immune+immune) in the real world, in order to provide some data reference for the first-line treatment population and regimen selection of advanced HCC.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.