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A Study of the Application of HAIC in Advanced HCC Previously Treated With ICIs and Antiangiogenic Agents

NCT05718492 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-02-08

No results posted yet for this study

Summary

Immune checkpoint inhibitors (ICIs) plus antiangiogenic agents can achieve better efficacy than sorafenib in the treatment of hepatocellular carcinoma (HCC) within a certain period of time, but more than half of the patients are still insensitive to the treatment. There is no evidence-based basis for second-line treatment after the progression of the disease.In view of the effectiveness of Hepatic arterial infusion (HAIC) in the first-line treatment of HCC in the Chinese population, this study intends to launch a prospective intervention study to explore the efficacy and safety of HAIC treatment in patients with advanced HCC after the failure of ICIs and antiangiogenic agents combination therapy, and to provide high-level evidence for optimizing the second-line treatment of advanced HCC in the future.

Conditions

Interventions

PROCEDURE

digital subtraction angiography.

Each patient received an artery catheter procedure guided by digital subtraction angiography.

DRUG

FOLFOX (oxaliplatin , leucovorin , fluorouracil , and fluorouracil )

Hepatic artery infusion chemotherapy. The FOLFOX (oxaliplatin 130 mg/m2, leucovorin 200 mg/m2, fluorouracil 400 mg/m2, and fluorouracil 2,400 mg/m2) regimen was sequentially infused through the catheter every cycle (3 weeks).

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Ming Zhao, M.D. & Ph.D. · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2022-10-18
Primary Completion
2025-10-18
Completion
2026-10-18

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 NCT05718492 on ClinicalTrials.gov