Hepatic Arterial Infusion Chemotherapy(HAIC) for Hepatoma After Resection (HAICAT)

August 9, 2017 updated by: Baocai Xing, Peking University Cancer Hospital & Institute

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

192

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Guang Cao, Doctor
        • Sub-Investigator:
          • Wei Liu, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 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).

Exclusion Criteria:

  • 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)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: HAIC treatment group
HAIC treatment after resection Intervention: Drug: Oxaliplatin, 5-fluorouracil (5-FU) Procedure/Surgery: Hepatic arterial catheter implantation
Drug: Oxaliplatin(OXA), 5-fluorouracil (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
Other Names:
  • OXA,5-FU
Procedure: Hepatic arterial catheter implantation
for the the HAIC treatment group: Hepatic arterial catheter implantation for HAIC
Other Names:
  • HAIC
NO_INTERVENTION: No HAIC treatment group
Best support care and follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence Free Survival
Time Frame: approximately 70 months from first patient first visit
approximately 70 months from first patient first visit

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to recurrence
Time Frame: approximately 60 months from first patient first visit
approximately 60 months from first patient first visit
Overall survival
Time Frame: approximately 60 months from first patient first visit
approximately 60 months from first patient first visit
Visual Analog Score for pain
Time Frame: approximately 60 months from first patient first visit
approximately 60 months from first patient first visit
Physicians Global Assessment to measure quality of life
Time Frame: approximately 60 months from first patient first visit
approximately 60 months from first patient first visit
Number of Participants With Abnormal Laboratory Values
Time Frame: approximately 60 months from first patient first visit
approximately 60 months from first patient first visit
Adverse Events That Are Related to Treatment
Time Frame: approximately 60 months from first patient first visit
approximately 60 months from first patient first visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University Cancer Hospital & Institute

Investigators

  • Study Director: Baocai Xing, Doctor, 1st Department of HBP Surgery.Beijing Cancer Hospital
  • Study Director: Xu Zhu, Doctor, Interventional therapy department of Beijing Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

April 3, 2016

First Submitted That Met QC Criteria

May 9, 2016

First Posted (ESTIMATE)

May 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BeijingCancerH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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