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Neoadjuvant HAIC of TACE Plus Donafenib in BCLC B Stage HCC: a Multi-center Randomized Controlled Trial.

NCT05171166 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-12-18

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of the combination therapy with HAIC-TACE and donafenib compared to TACE plus donafenib in patients with BCLC B stage unresectable hepatocellular carcinoma (HCC) out of up-to-seven criteria.

Conditions

Interventions

PROCEDURE

HAIC

Hepatic arterial infusion chemotherapy is consist of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 would be intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.

PROCEDURE

TACE

A standard hepatic artery catheter would be introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery would be performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply, the proportion of the liver supplied by each artery would be estimated by the arteriography. After optimal positioning of the catheter, cTACE or DEB-TACE protocol would be performed to embolize the tumor supplying artery blood flow until the stasis of the supplying artery.

DRUG

FOLFOX

oxaliplatin,leucovorin, and 5-FU

DRUG

cTACE or DEB-TACE

lipiodol or microspheres that mixed with EPI

DRUG

Donafenib

200 mg of donafenib (consisting of two 100-mg tablets) twice daily.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Xiaodong Wang, MD · Department of Interventional Therapy, Peking University Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-12-24
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT05171166 on ClinicalTrials.gov