Combining chemotherapy and immunotherapy for advanced liver cancer

Hepatic Arterial Infusion Chemotherapy Plus Lenvatinib and PD-1 Inhibitors Versus Lenvatinib Plus PD-1 Inhibitors As First-line Treatment for High Tumor Burden Advanced Hepatocellular Carcinoma with Portal Vein Tumor Thrombus: a Target Trial Emulation Study

This study is testing a new combination of chemotherapy and immunotherapy to see if it helps people with advanced liver cancer feel better and manage their condition.

Quick facts

• Study type: Observational
• Enrollment: 228 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: First Hospital of China Medical University (Academic / other)
• Drugs / interventions: lenvatinib, chemotherapy
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT06631326 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of hepatic arterial infusion chemotherapy (HAIC) combined with PD-1 inhibitors and Lenvatinib in patients suffering from high tumor burden advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT). Participants will receive HAIC alongside Lenvatinib and PD-1 inhibitors, with specific treatment cycles required for eligibility. The study aims to determine how well this combination therapy works in managing advanced HCC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with advanced HCC and portal vein tumor thrombus who have measurable intrahepatic lesions.

Not a fit: Patients without measurable lesions or those with earlier-stage HCC may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with advanced liver cancer.

How similar studies have performed: While this approach combines established treatments, the specific combination of HAIC with PD-1 inhibitors and Lenvatinib is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Age 18 to 80 years old;
2. Diagnosis of HCC was confirmed by histologic or cytologic analysis or clinical features according to the American Association for the Study of Liver Diseases (AASLD) guideline;
3. At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
4. HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
5. Presence of PVTT;
6. Patients received a first-line lenvatinib+PD-1 (L+P) inhibitors combination or that of HAIC+lenvatinib+PD-1 inhibitors (H+L+P). More specifically, the administration of lenvatinib was concomitant with PD-1 inhibitors, and HAIC was performed either concurrently with, or up to 2 months before or after the L+P inhibitors combination therapy. Patients in the H+L+P group should undergo at least 2 cycles of HAIC, receive at least 2 cycles of PD-1 inhibiors and take at least 2 months of lenvatinib. Patients in the L+P group should receive at least 2 cycles of PD-1 inhibiors, and take at least 2 months of lenvatinib.
7. Child-Pugh class A or B7;
8. Tumor burden meets up to 7 out criteria.

Exclusion Criteria:

1. Patients who took anti-tumor treatments before the combination therapy;
2. With other malignant tumors;
3. incomplete data.

Where this trial is running

Shenyang, Liaoning

• The first hospital of China medical university — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Principal investigator: Haibo Shao — First Hospital of China Medical University
• Study coordinator: Jiaxi Liu

Conditions HCC - Hepatocellular Carcinoma; Hepatic Arterial Infusion Chemotherapy; BCLC Stage C Hepatocellular Carcinoma; Lenvatinib; PD-1 Inhibitors