Clinical trial Recruiting at 1 site Observational Ages 18 to 75

Combining chemotherapy and targeted therapy for advanced liver cancer

Official title: Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study

Run by Sun Yat-sen University · NCT06333561 · Data updated 2026-11-12

This study is testing whether combining a specific type of chemotherapy with two targeted therapies can help people with advanced liver cancer feel better and improve their treatment results.

Quick facts

Study typeObservational
Ages18 Years to 75 Years
SexAll
Enrollment300 (estimated)
SponsorSun Yat-sen University
Academic / other
Drugs / interventionsLenvatinib, chemotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 1, 2021
Main results expectedDecember 30, 2024
Study endsDecember 30, 2025
Registry record updatedFebruary 6, 2025
Trial IDNCT06333561 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults aged 18 to 75 with primary infiltrative HCC and a Child-Pugh class A or B status.

Probably not a fit

Patients with HCC that has a tumor capsule or those who have received prior systemic therapies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the efficacy and safety of combining hepatic arterial infusion chemotherapy (HAIC) with lenvatinib and PD-1 inhibitors in patients with advanced infiltrative hepatocellular carcinoma (HCC). It aims to gather real-world data on treatment outcomes and clinical parameters from multiple centers. By creating a comprehensive database, the study seeks to address important clinical questions regarding this treatment approach.

Why it matters

Potential benefit: If successful, this study could provide a new standard of care for patients with infiltrative hepatocellular carcinoma, potentially improving treatment outcomes.

How similar studies have gone: While there is promising evidence for the combination of HAIC, lenvatinib, and PD-1 inhibitors in advanced HCC, this specific approach for infiltrative HCC is relatively novel and less explored.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. primary infiltrative HCC according to MRI or CT imaging characteristics.
2. Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
3. Lenvatinib as initial treatment.
4. patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.
5. no history of other malignancies.
6. no tumor thrombus in the atrium or vena cava.

Exclusion Criteria:

1. HCC with tumor capsule.
2. under 18 years or over 75 years.
3. TACE as initial treatment.
4. sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.
5. incomplete tumor imaging data.
6. lost to follow-up after treatment within three months.

Where it's running

  • Chinese PLA General hospital
    Beijing, Beijing Municipality, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.