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HAIC Combine With Lenvatinib and PD-1 Inhibitors for Advanced HCC With PVTT

NCT05166239 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-01-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy combined with Lenvatinib and PD-1 inhibitors compared to Lenvatinib plus PD-1 inhibitors for advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT).

Conditions

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 1

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 2

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

DRUG

PD-1 inhibitors 2

PD-1 inhibitors injection intravenously or percutaneously every 4 week.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Xiaodong Wang, MD · Peking University Cancer Hospital & Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2023-12-29
Completion
2025-12-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05166239 on ClinicalTrials.gov