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Hepatocellular CarcinomaPhase 3NCT03468231

HAIC of FOLFOX vs. HAIC of OXA for Advanced HCC

A Phase 3 study testing Sorafenib, HAIC of FOLFOX and HAIC of OXA in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 7 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT). 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?
Sorafenib, HAIC of FOLFOX and HAIC of OXA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
7 sitesChina
Study dates
9 Mar 2018to 9 Mar 2020
Phase
Phase 3
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
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  • 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

7 sites in 1 country.

Ming Shi, MD contact

(8620)-87343938

shiming@sysucc.org.cn

RongPing Guo, MD contact

(8620)-87342266

guorp@sysucc.org.cn

7 sites in 1 country

China7 sites, 7 recruiting

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059

    Wusheng Yu, MD, 13827285010, yuwusheng1998@126.com

    Recruiting

  • Cancer Center Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Ming Shi, MD, 86-2087343115, shiming@mail.sysu.edu.cn

    Ming Shi, MD

    Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510060

    Guosheng Tan, MD, 13725254145, tgs1976@163.com

    Recruiting

  • Guangzhou Twelfth People 's Hospital

    Guangzhou, Guangdong, 510620

    Yuanmin Zhou, MD, 15521278919, 13430288977@139.com

    Jinghua Chen, MD

    Recruiting

  • First Affiliated Hospital of University Of South China

    Hengyang, Hunan, 421001

    Xiaoping Wu, MD, 13975486015, wxp19730806@sina.com

    Recruiting

  • Kaiping Central Hospital

    Kaiping, Guangdong, 529300

    Shijie Zhang, MD, 13717287622, Shijie_9262511@163.com

    Recruiting

  • The First Affiliated Hospital Of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

    Xin Zheng, MD, 13649265446, 183421344@qq.com

    Recruiting

Other trials in China

About this study

Official title: Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin, Fluorouracil/Leucovorin Versus Sorafenib Plus Hepatic Artery Infusion Chemotherapy of Oxaliplatin for Hepatocellular Carcinoma With Major Portal Vein Tumor Thrombosis

The purpose of this study is to evaluate the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin compared with HAIC of oxaliplatin alone in patients with hepatocellular carcinoma (HCC) with major portal venous tumor thrombus (PVTT).

Read the detailed description

Sorafenib is the most widely used palliative treatment for hepatocellular carcinoma (HCC) patients with portal venous tumor thrombus (PVTT). Our previous prospective study revealed that sorafenib combined with hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin plus fluorouracil/leucovorin confer a survival benefit to HCC with major PVTT. However, HAIC of fluorouracil is not such for advanced HCC. Whether HAIC of oxaliplatin is as effective as HAIC of oxaliplatin plus fluorouracil/leucovorin is controversial. Thus, the investigators carried out this prospective randomized control study to find out it.

Being tested
Sorafenib, HAIC of FOLFOX, HAIC of OXA
Keywords
Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy, Sorafenib, Oxaliplatin plus Fluorouracil/Leucovorin, Oxaliplatin
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • SorafenibDrug

    Oral Sorafenib, 400mg, Bid

  • HAIC of FOLFOXDrug

    Also called Oxaliplatin , fluorouracil, and leucovorin

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

  • HAIC of OXADrug

    Also called Oxaliplatin

    administration of Oxaliplatin via the tumor feeding arteries

Study groups in NCT03468231
Study groupRoleWhat they receive
Sorafenib plus HAIC of FOLFOXActive comparatorSorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin, Fluorouracil and Leucovorin
Receives: Drug: Sorafenib; Drug: HAIC of FOLFOX
Sorafenbi plus HAIC of OXAExperimentalSorafenib combined with Hepatic arterial infusion chemotherapy with Oxaliplatin
Receives: Drug: Sorafenib; Drug: HAIC of OXA

What is being measured

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

  1. Overall survival

    Overall survival

    Measured: 10 months

Secondary outcomes (4)

  1. Progress free survival

    Progress free survival

    Measured: 10 months

  2. Adverse Events

    Number of adverse events. Postoperative adverse events were graded based on CTCAE v4.0

    Measured: 30 days

  3. Number of of Patients developed Adverse Events

    Number of of patients who developed adverse event. Postoperative adverse events were graded based on CTCAE v4.0

    Measured: 30 days

  4. Tumor response

    overall response

    Measured: 10 months

Timeline

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

  1. First posted16 Mar 2018
  2. Study start9 Mar 2018
  3. Primary completion9 Sep 2019 (estimated)
  4. Study completion9 Mar 2020 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03468231
Sponsor's protocol ID
HCC-20180309
Status last verified
Mar 2018
First submitted
11 Mar 2018
Last updated
16 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sorafenib, HAIC of FOLFOX and HAIC of OXA in people with Hepatocellular Carcinoma, run by Sun Yat-sen University at 7 sites 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: status not confirmed, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Ming Shi, MD ((8620)-87343938, shiming@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 10 months). 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 NCT03468231.

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 16 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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