Using chemotherapy and zoledronic acid to prevent bone metastases in advanced liver cancer

A Randomized Controlled Study of Hepatic Arterial Infusion Chemotherapy of FOLFOX With or Without Zoledronic Acid for the Prevention of Bone Metastases in Advanced Hepatocellular Carcinoma Staged at BCLC C

This study is testing if combining a special chemotherapy treatment with zoledronic acid can help people with advanced liver cancer live longer and avoid spreading cancer to their bones.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: lenvatinib, chemotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT05866172 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of hepatic arterial infusion chemotherapy (HAIC) combined with zoledronic acid in improving overall survival for patients with unresectable hepatocellular carcinoma (HCC). The study aims to determine if this combination can prevent the development of bone metastases, which is a common complication in advanced HCC. Patients enrolled must meet specific diagnostic and health criteria, ensuring they are suitable candidates for this treatment approach. The trial is conducted at the Cancer Center of Sun Yat-sen University in Guangzhou, Guangdong.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with unresectable hepatocellular carcinoma who meet specific health criteria and have not received prior treatment.

Not a fit: Patients with cirrhosis beyond Child-Pugh class A or those who have previously undergone treatment for HCC may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with advanced liver cancer.

How similar studies have performed: While zoledronic acid has been used in various malignancies, the combination with HAIC for HCC is a novel approach that has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* The diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL)
* Patients must have at least one tumor lesion that can be accurately measured according to EASL criteria.
* Unresectable HCC. For BCLC C HCC, sorafenib/lenvatinib or PD-1/L1 antibody was allowed.
* Eastern Cooperative Oncology Group performance status of 0 to 2
* with no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment.
* The following laboratory parameters:
* Platelet count ≥ 75,000/μL
* Hemoglobin ≥ 8.5 g/dL
* Total bilirubin ≤ 30mmol/L
* Serum albumin ≥ 30 g/L
* ASL and AST ≤ 5 x upper limit of normal
* Serum creatinine ≤ 1.5 x upper limit of normal
* INR ≤ 1.5 or PT/APTT within normal limits
* Absolute neutrophil count (ANC) \>1,500/mm3
* Ability to understand the protocol and to agree to and sign a written informed consent document

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
* Known central nervous system tumors including metastatic brain disease

Where this trial is running

Guangzhou, Guangdong

• Cancer Center Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Conditions: Hepatocellular Carcinoma, hepatocellular carcinoma, zoledronic Acid, hepatic arterial infusion chemotherapy