NCT04687163

Brief Summary

A randomized trial showed that sorafenib plus hepatic artery infusion of 85mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. However, a retrospective study showed that hepatic artery infusion of 130 mg/m² oxaliplatin, leucovorin and fluorouracil is more effective than sorafenib in advanced hepatocellular carcinoma. It is unknown which oxaliplatin dose is better.

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
400

participants targeted

Target at P50-P75 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

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

December 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

December 30, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 13, 2021

Status Verified

December 1, 2020

Enrollment Period

1.9 years

First QC Date

December 24, 2020

Last Update Submit

January 12, 2021

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    24 months

Secondary Outcomes (4)

  • progression-free survival

    24 months

  • objective response rate

    6 months

  • time to response

    12 months

  • Adverse Events

    30 Days after HAIC

Study Arms (2)

OXA 130

EXPERIMENTAL

Patients received sorafenib or lenvatinib Plus HAIC of 130 mg/m² oxaliplatin, and 2400 mg/m² 5-fu

Drug: HAIC of 130 mg/m² Oxaliplatin, and 5-fuDrug: TKI

OXA 85

ACTIVE COMPARATOR

Patients received sorafenib or lenvatinib Plus HAIC of 85 mg/m² oxaliplatin, and 2400 mg/m² 5-fu

Drug: HAIC of 85 mg/m² Oxaliplatin, and 5-fuDrug: TKI

Interventions

HAIC of 130 mg/m² Oxaliplatin, and 5-fuDRUG

Hepatic arterial infusion of 130 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU

OXA 130
HAIC of 85 mg/m² Oxaliplatin, and 5-fuDRUG

Hepatic arterial infusion of 85 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU

OXA 85
TKIDRUG

sorafenib 400mg bid or lenvatinib 12 mg/day (for bodyweight ≥60 kg) or 8 mg/day (for bodyweight \<60 kg)

OXA 130OXA 85

Eligibility Criteria

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

You may qualify if:

  • KPS≥70;
  • 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;
  • With vascular invasion or extrahepatic metastasis
  • Diagnosed as unresectable with consensus by the panel of liver surgery experts;
  • No past history of TACE, HAIC, chemotherapy or molecule-targeted treatment;
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • Meet the following laboratory parameters:(a) Platelet count ≥ 75,000/μL; (b)Hemoglobin ≥ 8.5 g/dL;(c) Total bilirubin ≤ 30mmol/L;(d) Serum albumin
  • ≥ 32 g/L;(e) ASL and AST ≤ 6 x upper limit of normal;(f) Serum creatinine
  • ≤ 1.5 x upper limit of normal;(g) INR \> 2.3 or PT/APTT within normal limits; (h) Absolute neutrophil count (ANC) \>1,500/mm3;
  • Ability to understand the protocol and to agree to and sign a written informed consent document.

You may not qualify if:

  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • Known of serious heart disease which can nor endure the treatment such as cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
  • 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.
  • Evidence of bleeding diathesis.
  • Any other hemorrhage/bleeding event \> CTCAE Grade 3 within 4 weeks of first dose of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Guangzhou Twelfth People 's Hospita

Guangzhou, Guangdong, 510620, China

RECRUITING

Kaiping Central Hospital

Kaiping, Guangdong, 529300, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic 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
Proffessor

Study Record Dates

First Submitted

December 24, 2020

First Posted

December 29, 2020

Study Start

December 30, 2020

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 13, 2021

Record last verified: 2020-12

Locations

CN(3)