Combining chemotherapy and targeted therapy for advanced liver cancer

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

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 type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: Lenvatinib, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06333561 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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 performed: 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.

Eligibility 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 this trial is running

Beijing, Beijing Municipality

• Chinese PLA General hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Feng Duan, MD — Chinese PLA General Hospital
• Study coordinator: Qunfang Zhou, MD

Conditions Hepatocellular Carcinoma; Lenvatinib; PD-1 Inhibitor; Hepatic Arterial Infusion Chemotherapy; Hepatic arterial infusion chemotherapy; Tislelizumab; Toripalimab; Sintilimab