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HAIC Plus Lenva and PD-1 for Advanced HCC With Macrovascular or Biliary Invasion

NCT07466225 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2026-03-12

No results posted yet for this study

Summary

The combination of HAIC with systemic therapy can provide superior efficacy compared to systemic therapy alone or local therapy alone for patients with advanced HCC complicated by vascular invasion, regardless of whether they have extrahepatic metastasis, with overall manageable safety. Currently, guidelines have recommended HAIC for HCC patients with unresectable primary tumors, PVTT type I/II/III/IV, and Child-Pugh A liver function, and recognize that its combination with sorafenib for patients with PVTT has superior efficacy compared to sorafenib monotherapy. However, more evidence is still needed regarding the efficacy of HAIC combined with lenvatinib and PD-1 inhibitors for patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion. This study aims to further validate the efficacy and safety of lenvatinib and PD-1 inhibitors ± HAIC for HCC patients with major vascular invasion (including PVTT/HVTT/IVCTT, etc.) and bile duct invasion through larger sample size multicenter real-world data, with the goal of providing new evidence-based guidance for HCC treatment in clinical practice. This study is to evaluate the efficacy and safety of HAIC combined with lenvatinib and PD-1 inhibitors versus lenvatinib combined with PD-1 inhibitors in the first-line treatment of advanced hepatocellular carcinoma with major vascular or biliary invasion

Conditions

  • Hepatocellular Carcinoma (HCC)

Interventions

PROCEDURE

HAIC

Hepatic arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks.

DRUG

Lenvatinib

12/8 mg (weight ≥ 60kg / \< 60 kg) of Lenvatinib once daily after HAIC.

DRUG

PD-1 Inhibitors

PD-1 inhibitors injection intravenously or percutaneously before 24h of HAIC every 4 week

DRUG

Lenvatinib 1

12/8 mg (weight ≥ 60kg / \< 60 kg) of Lenvatinib once daily.

DRUG

PD-1 inhibitors 1

PD-1 inhibitors injection intravenously or percutaneously every 4 week

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Xiaodong Wang · Peking University Cancer Hospital & Institute

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-06-30
Completion
2026-08-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07466225 on ClinicalTrials.gov