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Hepatocellular CarcinomaPhase 2NCT02981498

Phase II Trial of Sorafenib Combined With Concurrent HAIC for Hepatocellular Carcinoma

A Phase 2 study testing Hepatic arterial infusion chemotherapy and Folfox Protocol in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular carcinoma (HCC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Hepatic arterial infusion chemotherapy and Folfox Protocol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteChina
Study dates
Jun 2015to Apr 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • diagnosed with major or main portal vein invasion (Vp3 or Vp4)
  • KPS≥70；
  • with no previous treatment
  • No Cirrhosis or cirrhotic status of Child-Pugh class A only
Show all 17Show fewer
  • 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

Who cannot join

  • 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.
Show all 10Show fewer
  • Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Phase II Trial of Sorafenib Combined With Concurrent Hepatic Arterial Infusion (HAI) of Oxaliplatin, 5-fluorouracil and Leucovorin for Hepatocellular Carcinoma

To evaluate safety and efficacy of combined hepatic arterial infusion (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin and sorafenib in patients with advanced hepatocellular carcinoma (HCC).

Read the detailed description

In most current guidelines, unresectable HCC with major PVTT are considered not generally suitable for transarterial chemoembolization, and sorafenib is recommended as standard care.3-5 However, for patients with major PVTT, the median overall survival of those treated with sorafenib monotherapy was only 3.1 to 6.0 months.

Whether combining sorafenib with hepatic arterial infusion (HAIC) of oxaliplatin, 5-fluorouracil and leucovorin is safe, well tolerated, and efficacious remains unknown, with no prospective clinical data currently available.The investigators therefore conducted a prospective single center, single-arm phase II trial to evaluate the safety and efficacy of sorafenib combined with HAIC in patients with unresectable advanced HCC.

Being tested
Hepatic arterial infusion chemotherapy, Folfox Protocol
Keywords
Hepatic arterial infusion chemotherapy, Sorafenib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hepatic arterial infusion chemotherapyProcedure or surgery

    administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries

  • Folfox ProtocolDrug

    Oxaliplatin , fluorouracil, and leucovorin

Study groups in NCT02981498
Study groupRoleWhat they receive
Sorafenib combined with HAICExperimentalSorafenib combined with Hepatic arterial infusion chemotherapy with Folfox Protocol
Receives: Procedure: Hepatic arterial infusion chemotherapy; Drug: Folfox Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival rate

    Measured: 3 month

Secondary outcomes (3)

  1. Objective response

    Measured: 3 month

  2. OS

    Overall Survival

    Measured: 12 months

  3. AE event

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2016 (estimated)
  2. Study startJun 2015
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02981498
Sponsor's protocol ID
HCC-S027
Status last verified
Mar 2019
First submitted
1 Dec 2016
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Llovet JM, Real MI, Montana X, Planas R, Coll S, Aponte J, Ayuso C, Sala M, Muchart J, Sola R, Rodes J, Bruix J; Barcelona Liver Cancer Group. Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1734-9. doi: 10.1016/S0140-6736(02)08649-X.

    PubMed 12049862

  • Ando E, Yamashita F, Tanaka M, Tanikawa K. A novel chemotherapy for advanced hepatocellular carcinoma with tumor thrombosis of the main trunk of the portal vein. Cancer. 1997 May 15;79(10):1890-6. doi: 10.1002/(sici)1097-0142(19970515)79:103.0.co;2-k.

    PubMed 9149014

  • Luo J, Guo RP, Lai EC, Zhang YJ, Lau WY, Chen MS, Shi M. Transarterial chemoembolization for unresectable hepatocellular carcinoma with portal vein tumor thrombosis: a prospective comparative study. Ann Surg Oncol. 2011 Feb;18(2):413-20. doi: 10.1245/s10434-010-1321-8. Epub 2010 Sep 14.

    PubMed 20839057

  • He MK, Zou RH, Li QJ, Zhou ZG, Shen JX, Zhang YF, Yu ZS, Xu L, Shi M. Phase II Study of Sorafenib Combined with Concurrent Hepatic Arterial Infusion of Oxaliplatin, 5-Fluorouracil and Leucovorin for Unresectable Hepatocellular Carcinoma with Major Portal Vein Thrombosis. Cardiovasc Intervent Radiol. 2018 May;41(5):734-743. doi: 10.1007/s00270-017-1874-z. Epub 2018 Jan 11.

    PubMed 29327075

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hepatic arterial infusion chemotherapy and Folfox Protocol in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival rate (time frame: 3 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02981498, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.

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