MedTrace Logo

Hepatic Artery Infusion Chemotherapy Plus Donafenib in Patients With Hepatocellular Carcinoma After Surgery

NCT04962958 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-22

No results posted yet for this study

Summary

This is an open-label，multi-center ，non-randomized ，single arm exploratory study . This clinical study is an investigator-initiated clinical trial（IIT ）. The objective of this study is to evaluate if the addition of hepatic artery infusion chemotherapy (HAIC) and Donafenib after curative resection for hepatocellular carcinoma patients with a solitary tumor≥5 cm and microvascular invasion （MVI） will prevent or delay the recurrence of the disease.

Conditions

  • Carcinoma
  • Carcinoma, Hepatocellular
  • Liver Neoplasms
  • Digestive System Neoplasms
  • Antineoplastic Agents
  • Donafenib
  • Fluorouracil
  • Oxaliplatin
  • Antimetabolites

Interventions

PROCEDURE

Hepatic arterial infusion chemotherapy

administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

DRUG

Folfox Protocol

Oxaliplatin , fluorouracil, and leucovorin

DRUG

Donafenib

administration of Donafenib

Sponsors & Collaborators

  • Meng Chao Hepatobiliary Hospital of Fujian Medical University

    collaborator OTHER

  • Huashan Hospital

    collaborator OTHER

  • The Second Affiliated Hospital of Harbin Medical University

    collaborator OTHER

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Lei Zhang, PHD · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2024-03-31
Completion
2024-08-31

Countries

  • China

Study Locations

More Related Trials

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 NCT04962958 on ClinicalTrials.gov