Combining DEB-TACE with HAIC for large liver cancer
Official title: DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial
Run by Second Affiliated Hospital of Guangzhou Medical University · NCT06397235 · Data updated 2026-11-12
This study is testing if combining two types of chemotherapy treatments can help people with large liver cancer live longer and feel better compared to just one treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | May 1, 2024 |
| Main results expected | April 30, 2027 |
| Study ends | April 30, 2028 |
| Registry record updated | February 20, 2025 |
| Trial ID | NCT06397235 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with unresectable large HCC greater than 7 cm and adequate organ function.
✕Probably not a fit
Patients with macrovascular invasion, extrahepatic metastasis, or decompensated liver function are unlikely to benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the effectiveness and safety of combining transarterial chemoembolization with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) using oxaliplatin and raltitrexed for patients with unresectable large hepatocellular carcinoma (HCC) larger than 7 cm. The study is multicenter and randomized, enrolling 130 patients who will receive either the combination treatment or DEB-TACE alone. The primary focus is on progression-free survival, while secondary outcomes include tumor response, overall survival, and adverse events. Treatments can be repeated based on follow-up evaluations by a multidisciplinary team.
Why it matters
Potential benefit: If successful, this approach could improve tumor control and survival rates for patients with large unresectable HCC.
How similar studies have gone: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * HCC confirmed by histology/cytology or diagnosed clinically. * At least one measurable intrahepatic target lesion. * The largest tumor size \> 7 cm. * Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment. * Child-Pugh score 5-7. * ECOG performance status ≤ 1. * Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds. Exclusion Criteria: * Macrovascular invasion or extrahepatic metastasis. * Diffuse HCC. * Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy. * Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy. * Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment. * History of other malignancies. * Uncontrollable infection. * History of HIV. * Gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3. * History of organ or cells transplantation. * Pregnant or lactating patients.
Where it's running
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The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.