HAIC in Combination with PD-1 Inhibitors and Lenvatinib for High Tumor Burden Advanced HCC (CHANCE2416)

China Medical University

Status: Enrolling

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

Treatments: Procedure: hepatic artery infusion chemotherapy; Drug: Lenvatinib + PD-1 monoclonal antibody

Study type: Observational

Funder types: Other

Identifiers

NCT06631326

CHANCE2416

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with high tumor burden advanced-stage hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT).

Enrollment: 228 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

228 participants in 2 patient groups

HAIC plus Lenvatinib and PD-1 inhibitors

Description:

Each patient should receive at least 2 cycles of HAIC, 2 cycles of PD-1inhibitors and take at least 2 months of Lenvatinib. The interval between HAIC and Lenvatinib plus PD-1 inhibitors should be within 2 months.

Treatment:

Drug: Lenvatinib + PD-1 monoclonal antibody

Procedure: hepatic artery infusion chemotherapy

Lenvatinib plus PD-1 inhibitors

Description:

Each patient should receive at least 2 cycles of PD-1 inhibitors and 2 months of Lenvatinib.

Treatment:

Drug: Lenvatinib + PD-1 monoclonal antibody