Combining DEB-TACE with HAIC for large liver cancer

DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial

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: PHASE2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06397235 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable large HCC greater than 7 cm and adequate organ function.

Not a fit: Patients with macrovascular invasion, extrahepatic metastasis, or decompensated liver function are unlikely to benefit from this study.

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 performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility 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 this trial is running

Guangzhou, Guangdong

• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (RECRUITING)

Conditions: Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma, transarterial chemoembolization, drug-eluting beads, hepatic artery infusion chemotherapy, oxaliplatin, raltitrexe