ClinicalTrials.Veeva

Menu

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

Sun Yat-sen University logo

Sun Yat-sen University

Status and phase

Enrolling
Phase 3

Conditions

Hepatocellular Carcinoma

Treatments

Drug: Zoledronic acid
Procedure: HAIC

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

264 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

264 participants in 2 patient groups

HAIC with zoledronic Acid
Experimental group
Treatment:
Drug: Zoledronic acid
Procedure: HAIC
HAIC without zoledronic Acid
Active Comparator group
Treatment:
Procedure: HAIC

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems