CompletedNot Applicable

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

China244 participantsStarted 2021-01-01

Plain-language summary

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).

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. Age 18 to 80 years old;
✓. 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;
✓. At least one measurable intrahepatic lesion as per the RECIST 1.1 criteria;
✓. HCC staging of the patients are consistent with both the BCLC stage C and the CNLC stage IIIa.
✓. Presence of PVTT;
✓. 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.
✓. Child-Pugh class A or B7;
✓. Tumor burden meets up to 7 out criteria.

Exclusion criteria

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

What they're measuring

Overall survival (OS)

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT06631326

SponsorFirst Hospital of China Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-22

View on ClinicalTrials.gov More HCC - Hepatocellular Carcinoma trials