NCT05866172

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P50-P75 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started May 2023

Shorter than P25 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 19, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

1.6 years

First QC Date

May 10, 2023

Last Update Submit

May 10, 2023

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomazoledronic Acidhepatic arterial infusion chemotherapy

Outcome Measures

Primary Outcomes (1)

  • overall survival

    OS was defined as the duration from the date of randomization until the date of death from any cause. Participants who were lost to follow-up were censored at the last date the participant was known to be alive, and participants who remained alive were censored at the time of data cutoff.

    12 months

Secondary Outcomes (3)

  • Progression Free Survival (PFS)

    12 months

  • Objective Response Rate (ORR)

    12 months

  • Adverse Events

    30 days

Study Arms (2)

HAIC with zoledronic Acid

EXPERIMENTAL
Procedure: HAICDrug: Zoledronic acid

HAIC without zoledronic Acid

ACTIVE COMPARATOR
Procedure: HAIC

Interventions

HAICPROCEDURE

hepatic arterial infusion of oxaliplatin, LV and 5-fu (20h)

HAIC with zoledronic AcidHAIC without zoledronic Acid
Zoledronic acidDRUG

Zoledronic acid 4mg iv.drip

HAIC with zoledronic Acid

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 19, 2023

Study Start

May 10, 2023

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

May 19, 2023

Record last verified: 2023-05

Locations

CN(1)