NCT03048123

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) compared with transarterial chemoembolization (TACE) in patients with large and unresectable hepatocellular carcinoma staged BCLC A/B.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P75+ for phase_2 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

February 7, 2017

Last Update Submit

February 7, 2017

Conditions

Hepatocellular Carcinoma

Keywords

Hepatic arterial infusion chemotherapyTransarterial ChemoembolizationLarge and unresectable HCC

Outcome Measures

Primary Outcomes (1)

  • Disease control rate

    Best response based on RECIST

    16 months

Secondary Outcomes (2)

  • Time to progression

    16 months

  • Adverse Events

    30 Days after HAIC and TACE

Study Arms (2)

Hepatic arterial infusion chemotherapy

EXPERIMENTAL

Procedure/Surgery: Hepatic arterial infusion chemotherapy Drug: Folfox Protocol. Hepatic intraarterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin

Procedure: Hepatic arterial infusionDrug: Folfox Protocol

Transarterial chemoembolization

ACTIVE COMPARATOR

Procedure/Surgery: Transarterial chemoembolization Drug: TACE Drug Protocol. Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA)

Procedure: Transarterial chemoembolizationDrug: TACE Drug Protocol

Interventions

Hepatic arterial infusionPROCEDURE

A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially

Hepatic arterial infusion chemotherapy
Transarterial chemoembolizationPROCEDURE

Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.

Transarterial chemoembolization
Folfox ProtocolDRUG

oxaliplatin,leucovorin and 5-FU

Also known as: Folfox for TAI
Hepatic arterial infusion chemotherapy
TACE Drug ProtocolDRUG

lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)

Also known as: Drugs for transarterial chemotherapy and embolization
Transarterial chemoembolization

Eligibility Criteria

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

You may qualify if:

  • Age range from 18-75 years;
  • 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), simultaneously staged as BCLC A or BCLC B based on Barcelona Clinic Liver Cancer staging system.
  • Patients must have at least one tumor lesion that can be accurately measured;
  • Solitary tumor with diameter ≥10cm, invaded both left and right lobe; or multiple tumors, diameter of the largest was more than 7cm.
  • Diagnosed as unresectable with consensus by the panel of liver surgery experts;
  • Re commanded treated by TAI or TACE with consensus by the panel of liver MDT;
  • No past history of TACE, TAI, chemotherapy or molecule-targeted treatment;
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
  • No liver protection therapy in 2 weeks before enrolled, and 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
  • Serious non-healing wound, ulcer, or bone fracture
  • Known central nervous system tumors including metastatic brain disease
  • Poor compliance that can not comply with the course of treatment and follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Folfox protocolPharmaceutical PreparationsEmbolization, Therapeutic

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hemostatic TechniquesTherapeuticsTherapeutic Occlusion

Study Officials

  • Ming Shi, MD

    The Department of Hepatobiliary Oncology of Sun Yat-sen University Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Proffessor

Study Record Dates

First Submitted

February 7, 2017

First Posted

February 9, 2017

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

January 24, 2017

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

CN(1)