Combining two treatments for large liver cancer

Transarterial Chemoembolization With Drug-eluting Beads Plus Hepatic Arterial Infusion Chemotherapy Versus Hepatic Arterial Infusion Chemotherapy Alone for Large Hepatocellular Carcinoma

This study is testing if combining two cancer treatments can help people with large liver tumors live longer and have better outcomes than using just one treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Second Affiliated Hospital of Guangzhou Medical University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05263219 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, randomized study aims to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) versus HAIC alone for patients with unresectable large hepatocellular carcinoma (HCC) greater than 7 cm. A total of 230 patients will be enrolled and randomly assigned to receive either the combination treatment or HAIC alone. The primary endpoint is overall survival, while secondary endpoints include tumor response, conversion to resection success rate, progression-free survival, and adverse events. Treatment will be administered through a microcatheter, with follow-up assessments to evaluate the potential for surgical resection.

Who should consider this trial

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

Not a fit: Patients with extrahepatic metastasis or significant portal vein involvement are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve overall survival rates for patients with large unresectable HCC.

How similar studies have performed: Other studies have shown promising results with similar combination therapies, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* Patients with HCC confirmed by histology/cytology or diagnosed clinically.
* The maximum HCC lesion \> 7 cm.
* Unresectable HCC evaluated by the surgeon team.
* At least one measurable intrahepatic target lesion.
* Patients without cirrhosis, or with cirrhosis but the liver function of Child-Pugh Class A.
* ECOG score of performance status ≤ 1 point.
* Adequate organ and bone marrow function; the blood biochemical examination: platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, ASL and AST≤5×ULN, creatinine≤1.5×ULN, INR\<1.5 or PT/APTT normal range.
* Life expectancy of at least 3 months.

Exclusion Criteria:

* Accompanied with tumor thrombus involving the main portal vein or bilateral first-order branch of portal vein.
* Accompanied with vena cava tumor thrombus.
* Extrahepatic metastasis.
* Previous treatment with TACE, HAIC, liver transplantation, resection, ablation, radiotherapy, or systemic therapy.
* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
* Those with organs (heart and kidneys) dysfunction who cannot tolerate TACE or HAIC treatment.
* History of other malignancies.
* Uncontrollable infection.
* History of HIV.
* Allergic to the drugs involved in the research.
* Patients with gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3.
* History of organ or cells transplantation.
* Those with bleeding tendency.

Where this trial is running

Guangzhou, Guangdong

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

Study contacts

• Study coordinator: Mingyue Cai, Dr.

Conditions: Unresectable Hepatocellular Carcinoma, Hepatocellular Carcinoma, Transarterial chemoembolization, Hepatic arterial infusion chemotherapy