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Hepatocellular CarcinomaPhase 2/3HAICATNCT02767375

Hepatic Arterial Infusion Chemotherapy(HAIC) for Hepatoma After Resection

A Phase 2/3 study testing Oxaliplatin(OXA), 5-fluorouracil (5-FU) and Hepatic arterial catheter implantation in people with Hepatocellular Carcinoma, run by Peking University Cancer Hospital & Institute at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

To study if the addition of HAIC following complete removal of early stage liver cancer of HCC will prevent or delay the recurrence of the disease. Half of the participant will receive two cycles of the HAIC after the hepatectomy, while the other half will return to the baseline surveillance schedule. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Oxaliplatin(OXA), 5-fluorouracil (5-FU) and Hepatic arterial catheter implantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteChina
Study dates
Feb 2015to Dec 2018
Phase
Phase 2/3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years and older
  • Informed consent Confirmation of diagnosis of HCC: For subjects undergoing surgical resection histological confirmation is mandatory (a post surgery pathology report is required for both histological confirmation and risk stratification).
  • After qualifying at the time of scanning, by independent radiology review diagnosed CR (no residual tumor deposit radical therapy Assess their level of risk of disease recurrence by tumor characteristics as moderate or high risk
  • Subjects who have undergone surgical resection for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment.
  • At least 3 weeks (21 days) but not more than 7 weeks (49 days), from resection course, to CT/MRI scan date. A timeframe of 4 weeks after surgical resection is recommended.
  • Male or female subjects ≥ 18 years of age Confirmation of complete response(CR)- (absence of residual tumor after curative treatment), on the eligibility scan by independent radiological review.
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  • For subjects undergoing surgical resection pathology proven complete removal of tumor. Intermediate or High Risk of recurrence as assessed by tumor characteristics.
  • Child-Pugh score 5 -7 points. A Child-Pugh score of 7 points is allowed only in the absence of ascites.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0.
  • Adequate bone marrow, liver and renal function as assessed by central lab by means of the following laboratory requirements from samples within 14 days prior to randomization: Alpha fetoprotein ≤ 400 ng/mL
  • Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of treatment (assessed centrally).

Who cannot join

  • Recurrent HCC Child-Pugh score 7 points with presence of ascites.
  • The following tumor characteristics: Low risk of recurrence after curative treatment defined as any of the following: for local ablation patients: single lesions ≤ 2 cm for surgical resection patients: single lesions ≤ 2 cm without microscopic vascular invasion, without tumor satellites and histologically well differentiated. ≥ 3 lesions or 2-3 lesions of which any are ≥ 3 cm in size (largest diameter, unidimensional measurement) prior curative treatment (surgical resection or local ablation) single lesion ≥ 5 cm (largest diameter, unidimensional measurement) in size prior local ablation.
  • Macrovascular invasion Extrahepatic spread (including regional lymph nodes and invasion into adjacent structures)
  • History of cardiovascular disease:
  • History of HIV infection Active clinically serious infections (≥ grade 2 NCI-CTCAE version 3.0)
  • Subjects with seizure disorder requiring medication (such as steroids or anti-epileptics)
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  • History of organ allograft Subjects with evidence or history of bleeding diathesis
  • Subjects undergoing renal dialysis
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors [Ta, Tis \& T1] or any cancer curatively treated ≥ 3 years prior to study entry as defined by the signing of informed consent.
  • Uncontrolled ascites (defined as not easily controlled with diuretic treatment)
  • Encephalopathy History of GI bleeding within 30 days of randomization.
  • Subjects with a history of esophageal varices bleeding which has not been followed by effective therapy and/or treatment to prevent bleeding recurrence.
  • Prior anti cancer therapy for treatment of HCC (including sorafenib or any other molecular therapy) is excluded.
  • Major surgery within 4 weeks of start of study as defined by the signing of informed consent, except for surgical resection or local ablation of HCC.
  • Autologous bone marrow transplant or stem cell rescue within 4 months of study entry as defined by the signing of informed consent.
  • Use of biologic response modifiers, such as colony stimulating factor(G-CSF), within 3 week of study entry, as defined by the signing of informed consent.
  • Investigational drug therapy outside of this trial during or within 4 weeks of study entry, as defined by the signing of informed consent.
  • Pregnant or breast-feeding subjects.
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
  • Known or suspected allergy to contrast media for angiography.
  • Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study
  • This applies to subjects with severe obstruction of the upper GI tract that require gavage.

Trial locations and contacts

1 site in 1 country.

Guang Cao, Doctor contact

86-138-1165-2497

caoguang1207@bjmu.edu.cn

Wei Liu, Doctor contact

86-138-1083-9736

huoxinglaotai@163.com

China1 site, 1 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Guang Cao, Doctor, 86-138-1165-2497, caoguang1207@bjmu.edu.cn

    Wei Liu, Doctor, 86-138-1083-9736, huoxinglaotai@163.com

    Recruiting

Other trials in China

About this study

Official title: Hepatic Arterial Infusion Chemotherapy as Adjuvant Treatment in the Prevention of Recurrence of Hepatocellular Carcinoma(HCC): A Prospective Randomized Controlled Clinical Trial

To study if the addition of HAIC following complete removal of early stage liver cancer of HCC will prevent or delay the recurrence of the disease. Half of the participant will receive two cycles of the HAIC after the hepatectomy, while the other half will return to the baseline surveillance schedule.

Read the detailed description

The high incidence of HCC recurrence following liver resection is a serious issue. The recurrent rate is as high as 50-60% at 3 years and 70-100% at 5 years.

So to reduce the recurrence rate of HCC, some interventions had been tried in clinic, including transarterial chemoembolization (TACE), immunotherapy, and interferon treatment etc. But few of these adjuvant therapies had been proved effective and the long term efficacy and clinical application remained further explored.

HAIC had been prove to be effective adjuvant treatment in patients with liver metastasis of colorectal cancers in randomized controlled trials and meta-analysis, but the role of adjuvant HAIC after liver resection is controversial. The results getting from different randomized control trials varied significantly because of the bias of patient selection, different study design，the small size of sample, different drug used in chemotherapy and lack of proper stratification,so a big sample size, well patients selected and well designed randomized controlled trial is needed to further confirm the role of the postoperative HAIC.

Patients with HCC who received curative liver resection (R0) were randomly assigned 1:1 by the doctors to receive no adjuvant HAIC(control group) or HAIC (treatment group). All patients in the treatment group will receive 2 cycles of adjuvant HAIC within 3 months after liver resection. The outcomes of patients were evaluated during the 5-years follow up.

Being tested
Oxaliplatin(OXA), 5-fluorouracil (5-FU), Hepatic arterial catheter implantation
Keywords
Hepatocellular Carcinoma, Hepatic arterial infusion chemotherapy
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • Oxaliplatin(OXA), 5-fluorouracil (5-FU)Drug

    Also called OXA,5-FU

    for the HAIC treatment group OXA 85mg/m2, d1，0-4h 5-FU 1500mg/m2 d1, 4-24h 24 hours in d1 \& 2 , IA，q4-6 Weeks

  • Hepatic arterial catheter implantationProcedure or surgery

    Also called HAIC

    for the the HAIC treatment group: Hepatic arterial catheter implantation for HAIC

Study groups in NCT02767375
Study groupRoleWhat they receive
HAIC treatment groupActive comparatorHAIC treatment after resection Intervention: Drug: Oxaliplatin, 5-fluorouracil (5-FU) Procedure/Surgery: Hepatic arterial catheter implantation
Receives: Drug: Oxaliplatin(OXA), 5-fluorouracil (5-FU); Procedure: Hepatic arterial catheter implantation
No HAIC treatment groupNo interventionBest support care and follow up

What is being measured

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

  1. Recurrence Free Survival

    Measured: approximately 70 months from first patient first visit

Secondary outcomes (6)

  1. Time to recurrence

    Measured: approximately 60 months from first patient first visit

  2. Overall survival

    Measured: approximately 60 months from first patient first visit

  3. Visual Analog Score for pain

    Measured: approximately 60 months from first patient first visit

  4. Physicians Global Assessment to measure quality of life

    Measured: approximately 60 months from first patient first visit

  5. Number of Participants With Abnormal Laboratory Values

    Measured: approximately 60 months from first patient first visit

  6. Adverse Events That Are Related to Treatment

    Measured: approximately 60 months from first patient first visit

Timeline

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

  1. First posted10 May 2016 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2018 (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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02767375
Sponsor's protocol ID
BeijingCancerH
Acronym
HAICAT
Status last verified
Aug 2017
First submitted
3 Apr 2016
Last updated
10 Aug 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Clinical Practice Guidelines for Hepatocellular Carcinoma Differ between Japan, United States, and Europe. Liver Cancer. 2015 Mar;4(2):85-95. doi: 10.1159/000367730. No abstract available.

    PubMed 26020031

  • Qi X, Liu L, Wang D, Li H, Su C, Guo X. Hepatic resection alone versus in combination with pre- and post-operative transarterial chemoembolization for the treatment of hepatocellular carcinoma: A systematic review and meta-analysis. Oncotarget. 2015 Nov 3;6(34):36838-59. doi: 10.18632/oncotarget.5426.

    PubMed 26451613

  • Lee JH, Lee Y, Lee M, Heo MK, Song JS, Kim KH, Lee H, Yi NJ, Lee KW, Suh KS, Bae YS, Kim YJ. A phase I/IIa study of adjuvant immunotherapy with tumour antigen-pulsed dendritic cells in patients with hepatocellular carcinoma. Br J Cancer. 2015 Dec 22;113(12):1666-76. doi: 10.1038/bjc.2015.430. Epub 2015 Dec 10.

    PubMed 26657650

  • Zhong JH, Li H, Li LQ, You XM, Zhang Y, Zhao YN, Liu JY, Xiang BD, Wu GB. Adjuvant therapy options following curative treatment of hepatocellular carcinoma: a systematic review of randomized trials. Eur J Surg Oncol. 2012 Apr;38(4):286-95. doi: 10.1016/j.ejso.2012.01.006. Epub 2012 Jan 24.

    PubMed 22281155

  • Kumamoto T, Tanaka K, Matsuo K, Takeda K, Nojiri K, Mori R, Taniguchi K, Matsuyama R, Ueda M, Akiyama H, Ichikawa Y, Ota M, Endo I. Adjuvant hepatic arterial infusion chemotherapy with 5-Fluorouracil and interferon after curative resection of hepatocellular carcinoma: a preliminary report. Anticancer Res. 2013 Dec;33(12):5585-90.

    PubMed 24324102

  • Tung-Ping Poon R, Fan ST, Wong J. Risk factors, prevention, and management of postoperative recurrence after resection of hepatocellular carcinoma. Ann Surg. 2000 Jul;232(1):10-24. doi: 10.1097/00000658-200007000-00003.

    PubMed 10862190

  • Nitta H, Beppu T, Imai K, Hayashi H, Chikamoto A, Baba H. Adjuvant hepatic arterial infusion chemotherapy after hepatic resection of hepatocellular carcinoma with macroscopic vascular invasion. World J Surg. 2013 May;37(5):1034-42. doi: 10.1007/s00268-013-1957-1.

    PubMed 23435678

  • Nagano H. Treatment of advanced hepatocellular carcinoma: intraarterial infusion chemotherapy combined with interferon. Oncology. 2010 Jul;78 Suppl 1:142-7. doi: 10.1159/000315243. Epub 2010 Jul 8.

    PubMed 20616597

  • Song MJ. Hepatic artery infusion chemotherapy for advanced hepatocellular carcinoma. World J Gastroenterol. 2015 Apr 7;21(13):3843-9. doi: 10.3748/wjg.v21.i13.3843.

    PubMed 25852268

  • Shiozawa K, Watanabe M, Ikehara T, Kogame M, Matsui T, Okano N, Kikuchi Y, Nagai H, Ishii K, Makino H, Igarashi Y, Sumino Y. Comparison of Sorafenib and Hepatic Arterial Infusion Chemotherapy for Advanced Hepatocellular Carcinoma: A Propensity Score Matching Study. Hepatogastroenterology. 2014 Jun;61(132):885-91.

    PubMed 26158136

  • Bruix J, Takayama T, Mazzaferro V, Chau GY, Yang J, Kudo M, Cai J, Poon RT, Han KH, Tak WY, Lee HC, Song T, Roayaie S, Bolondi L, Lee KS, Makuuchi M, Souza F, Berre MA, Meinhardt G, Llovet JM; STORM investigators. Adjuvant sorafenib for hepatocellular carcinoma after resection or ablation (STORM): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Oncol. 2015 Oct;16(13):1344-54. doi: 10.1016/S1470-2045(15)00198-9. Epub 2015 Sep 8.

    PubMed 26361969

  • Korean Liver Cancer Study Group (KLCSG); National Cancer Center, Korea (NCC). 2014 Korean Liver Cancer Study Group-National Cancer Center Korea practice guideline for the management of hepatocellular carcinoma. Korean J Radiol. 2015 May-Jun;16(3):465-522. doi: 10.3348/kjr.2015.16.3.465. Epub 2015 May 13.

    PubMed 25995680

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Oxaliplatin(OXA), 5-fluorouracil (5-FU) and Hepatic arterial catheter implantation in people with Hepatocellular Carcinoma, run by Peking University Cancer Hospital & Institute 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 11 inclusion and 22 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 10 Aug 2017. 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 combined 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.

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 Guang Cao, Doctor (86-138-1165-2497, caoguang1207@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence Free Survival (time frame: approximately 70 months from first patient first visit). 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 NCT02767375, which also lists 12 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 10 Aug 2017.

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