HAIC Combined Withzoledronic Acid for the Prevention of Bone Metastases in Advanced HCC

Trial Title: HAIC Combined Withzoledronic Acid for the Prevention of Bone Metastases in Advanced HCC

NCT ID: NCT05866172

Condition: Hepatocellular Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Zoledronic Acid

Conditions: Keywords:
hepatocellular carcinoma
zoledronic Acid
hepatic arterial infusion chemotherapy

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: HAIC
Description: hepatic arterial infusion of oxaliplatin, LV and 5-fu (20h)
Arm group label: HAIC with zoledronic Acid
Arm group label: HAIC without zoledronic Acid

Intervention type: Drug
Intervention name: Zoledronic acid
Description: Zoledronic acid 4mg iv.drip
Arm group label: HAIC with zoledronic Acid

Summary: Zoledronic acid was initially used for bone metastases in various malignancies. However, it is unknown whether hepatic arterial infusion chemotherapy combined with zoledronic acid can improve overall survival of unresectable hepatocellular carcinoma.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Center Sun Yat-sen University

Address:
City: Guangzhou
Zip: 510060
Country: China

Status: Recruiting

Contact:
Last name: Ming Shi, MD

Phone: 8620-87343115
Email: shiming@mail.sysu.edu.cn

Start date: May 10, 2023

Completion date: June 1, 2025

Lead sponsor:
Agency: Sun Yat-sen University
Agency class: Other

Source: Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05866172