Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06397235

DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC

Led by Second Affiliated Hospital of Guangzhou Medical University · Updated on 2025-02-20

130

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital of Guangzhou Medical University

Lead Sponsor

Z

Zhongshan People's Hospital, Guangdong, China

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).

CONDITIONS

Official Title

DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed hepatocellular carcinoma by histology, cytology, or clinical diagnosis
  • At least one measurable tumor inside the liver
  • Largest tumor size greater than 7 cm
  • Tumor recurrence allowed after curative treatments like surgery or ablation
  • Child-Pugh liver function score between 5 and 7
  • ECOG performance status of 0 or 1
  • Adequate blood cell counts and organ function (specified platelet, leukocyte, neutrophil counts, liver enzymes, kidney function, and prothrombin time limits)
Not Eligible

You will not qualify if you...

  • Presence of major blood vessel invasion or cancer spread outside the liver
  • Diffuse hepatocellular carcinoma
  • Decompensated liver disease including ascites, bleeding from varices, or hepatic encephalopathy
  • Previous palliative treatments such as TACE, arterial embolization, HAIC, radiation, or systemic therapy
  • Heart or kidney dysfunction preventing TACE or HAIC
  • History of other cancers
  • Uncontrolled infections
  • History of HIV infection
  • Recent or severe gastrointestinal bleeding
  • History of organ or cell transplantation
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China, 510260

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC | DecenTrialz