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Carcinoma, HepatocellularPhase 3NCT02738697

Adjuvant Chemotherapy With FOLFOX in HCC Patients After Resection

A Phase 3 study testing Adjuvant chemotherapy and Follow-up in people with Carcinoma, Hepatocellular, run by Sun Yat-sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second leading cause of cancer-related death. Surgical resection is still the main radical approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further improvement of prognosis of HCC patients. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Adjuvant chemotherapy and Follow-up
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
1 siteChina
Study dates
Jan 2016to Dec 2021
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

  • Age 18~75 years;
  • Eastern Cooperative Oncology Group performance status (ECOG PS) score <=2;
  • Histologically confirmed hepatocellular carcinoma with microvessels invasion;
  • No previous treatment for HCC;
  • More than 5 cm solitary tumor before surgery confirmed by more than 2 radiological examinations;
  • R0 resection achieved;
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  • No recurrence evidence in radiological follow-up 3~5 weeks after surgery;
  • Adequate hematologic parameters and liver and kidney functions: (1) Neutrophils Absolute >=1.5*10^9/L; (2) Hemoglobin >=90g/L; (3) Platelet count >=75*10^9/L; (4) Serum albumin >=35g/L; (5) Serum total bilirubin <=1.5*upper limit of normal (ULN); (6) Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <2.5*ULN; (7) Serum creatinine <=1.5*ULN; (8) International normalized ratio (INR)<=1.5;
  • Give signed informed consent before enrollment.

Who cannot join

  • Function impairment of vital organs (heart, lung, kidney, etc), serious infection or >grade 2 adverse events (Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0);
  • Histologically confirmed of positive resection margin (R1 resection);
  • Previous or current malignant tumor beyond HCC;
  • Allergy to any agent of the FOLFOX regimen;
  • History of organ transplantation;
  • Previously receiving other treatments for HCC;
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  • Pregnant or breastfeeding women, and women of childbearing potential without adequate contraception;
  • Neurological or mental abnormalities that may affect cognitive assessment and inform consent;
  • Concomitant anti-tumor therapy or participating in other interventional clinical trials;
  • Other psychological, family or social reason, which would affect compliance with the study protocol.

Trial locations and contacts

1 site in 1 country.

Rong-Ping Guo, M.D. contact

00862087342266

guorp@sysucc.org.cn

Wei Wei, Ph.D. M.D. contact

00862087343790

weiwei@sysucc.org.cn

China1 site, 1 recruiting

  • SUN YAT-SEN University Cancer Center

    Guangzhou, Guangdong, 510060

    Rong-Ping Guo, M.D., 00862087342266, guorp@sysucc.org.cn

    Wei Wei, Ph.D. M.D., 00862087343790, weiwei@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: The Clinical Randomized Trial of Adjuvant Chemotherapy With FOLFOX in HCC Patients at High Risk After Resection

Hepatocellular carcinoma (HCC) is the sixth most common malignancies worldwide and the second leading cause of cancer-related death. Surgical resection is still the main radical approach for HCC, but the recurrence rate after hepatectomy is very high, which hampers the further improvement of prognosis of HCC patients. The conventional risk factors of recurrence including: huge tumor, multiple lesions, vessels invasion and tumor rupture. Recently, the microvessels invasion (MVI) has been recognized a novel risk factor of recurrence after hepatectomy. The investigators' previous study showed that the recurrence rate is more than 50% for the patients with >5cm solitary tumor and MVI. The MVI was confirmed as the only independent risk factor for the overall and disease-free survival of HCC patients in multiple variables analysis. It is important to reduce the recurrence and prolong the survival of patients after hepatectomy with effective adjuvant therapy. Reported at 2014 American Society of Clinical Oncology (ASCO) annual meeting, A phase III randomized, double-blind, placebo-controlled trial of adjuvant sorafenib after resection or ablation to prevent recurrence of hepatocellular carcinoma (STORM trial) failed to meet the primary endpoint-recurrence free survival (RFS). Given the inspiring result of a recent trial, which compared with single agent of doxorubicin, the oxaliplatin-containing regimens (FOLFOX) showed significant improvement in OS, objective response rate (ORR) and disease control rate (DCR) in Asian (especially China) HCC patients. Based on these rationales, the investigators design the current prospective randomized clinical trial to evaluate the effect of adjuvant chemotherapy with FOLFOX to prolong the overall survival and reduce the recurrence in HCC patients at high risk (>5cm solitary tumor and MVI) after resection, compared to vigilant follow-up.

Read the detailed description

The patients with solitary tumor more than 5cm and microvessels invasion after radical hepatectomy were randomized to receive adjuvant FOLFOX chemotherapy （8~12 cycles) or follow-up. The main endpoint: overall survival (OS), disease-free survival(DFS) and safety were compared between this two groups.

Being tested
Adjuvant chemotherapy, Follow-up
Keywords
Carcinoma,Hepatocellular, Adjuvant chemotherapy, Microvessels invasion, Survival, Recurrence
Medical subject headings
Carcinoma, Hepatocellular, Recurrence

What participants receive

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

  • Adjuvant chemotherapyDrug

    Also called adjuvant chemotherapy with FOLFOX

    8~12 cycles of adjuvant chemotherapy with FOLFOX were performed 4-6 weeks after radical surgery

  • Follow-upProcedure or surgery

    Patients received just follow-up instead of adjuvant chemotherapy

Study groups in NCT02738697
Study groupRoleWhat they receive
Adjuvant chemotherapyExperimental8~12 cycles of adjuvant chemotherapy with FOLFOX were performed 4-6 weeks after radical surgery
Receives: Drug: Adjuvant chemotherapy
Follow-upOtherRoutine follow-up were performed instead of adjuvant chemotherapy
Receives: Procedure: Follow-up

What is being measured

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

  1. Overall survival

    The overall survival is defined as the percentage of patients who are alive at 5 years after their enrollments of this study.

    Measured: 5 years

Secondary outcomes (2)

  1. Disease-free survival

    The disease-free survival is defined as the percentage of patients who are alive at 5 years without any signs or symptoms of HCC after their enrollments of this study.

    Measured: 5 years

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 5 years

Timeline

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

  1. First posted14 Apr 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionDec 2020 (estimated)
  4. Study completionDec 2021 (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
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738697
Sponsor's protocol ID
SYSUCC-HCC-ADCHEMO
Status last verified
Nov 2016
First submitted
24 Mar 2016
Last updated
2 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Qin S, Cheng Y, Liang J, Shen L, Bai Y, Li J, Fan J, Liang L, Zhang Y, Wu G, Rau KM, Yang TS, Jian Z, Liang H, Sun Y. Efficacy and safety of the FOLFOX4 regimen versus doxorubicin in Chinese patients with advanced hepatocellular carcinoma: a subgroup analysis of the EACH study. Oncologist. 2014 Nov;19(11):1169-78. doi: 10.1634/theoncologist.2014-0190. Epub 2014 Sep 15.

    PubMed 25223462

  • Qin S, Bai Y, Lim HY, Thongprasert S, Chao Y, Fan J, Yang TS, Bhudhisawasdi V, Kang WK, Zhou Y, Lee JH, Sun Y. Randomized, multicenter, open-label study of oxaliplatin plus fluorouracil/leucovorin versus doxorubicin as palliative chemotherapy in patients with advanced hepatocellular carcinoma from Asia. J Clin Oncol. 2013 Oct 1;31(28):3501-8. doi: 10.1200/JCO.2012.44.5643. Epub 2013 Aug 26.

    PubMed 23980077

  • Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Haussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008 Jul 24;359(4):378-90. doi: 10.1056/NEJMoa0708857.

    PubMed 18650514

  • Llovet JM, Di Bisceglie AM, Bruix J, Kramer BS, Lencioni R, Zhu AX, Sherman M, Schwartz M, Lotze M, Talwalkar J, Gores GJ; Panel of Experts in HCC-Design Clinical Trials. Design and endpoints of clinical trials in hepatocellular carcinoma. J Natl Cancer Inst. 2008 May 21;100(10):698-711. doi: 10.1093/jnci/djn134. Epub 2008 May 13.

    PubMed 18477802

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adjuvant chemotherapy and Follow-up in people with Carcinoma, Hepatocellular, 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 9 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 2 Nov 2016. 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 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 Rong-Ping Guo, M.D. (00862087342266, guorp@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: 5 years). 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 NCT02738697, which also lists 5 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 2 Nov 2016.

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