Hepatic Arterial Infusion Chemotherapy(HAIC) for Hepatoma After Resection

NCT02767375 | Unknown Phase 2 DMC

• 1 other identifier: BeijingCancerH
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Hepatic arterial infusion chemotherapy

Outcome Measures

Primary Outcomes (1)

• Recurrence Free Survival

  approximately 70 months from first patient first visit

Secondary Outcomes (6)

• Time to recurrence

  approximately 60 months from first patient first visit

• Overall survival

  approximately 60 months from first patient first visit

• Visual Analog Score for pain

  approximately 60 months from first patient first visit

• Physicians Global Assessment to measure quality of life

  approximately 60 months from first patient first visit

• Number of Participants With Abnormal Laboratory Values

  approximately 60 months from first patient first visit

Study Arms (2)

HAIC treatment group

ACTIVE COMPARATOR

HAIC treatment after resection Intervention: Drug: Oxaliplatin, 5-fluorouracil (5-FU) Procedure/Surgery: Hepatic arterial catheter implantation

Drug: Oxaliplatin(OXA), 5-fluorouracil (5-FU); Procedure: Hepatic arterial catheter implantation

No HAIC treatment group

NO INTERVENTION

Best support care and follow up

Interventions

Oxaliplatin(OXA), 5-fluorouracil (5-FU) DRUG

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

Also known as: OXA,5-FU

HAIC treatment group

Hepatic arterial catheter implantation PROCEDURE

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

Also known as: HAIC

HAIC treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 26020031 BACKGROUND

• 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.

  PMID: 26451613 BACKGROUND

• 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.

  PMID: 26657650 BACKGROUND

• 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.

  PMID: 22281155 BACKGROUND

• 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.

  PMID: 24324102 BACKGROUND

• 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.

  PMID: 10862190 BACKGROUND

• 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.

  PMID: 23435678 BACKGROUND

• 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.

  PMID: 20616597 BACKGROUND

• 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.

  PMID: 25852268 BACKGROUND

• 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.

  PMID: 26158136 BACKGROUND

• 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.

  PMID: 26361969 BACKGROUND

• 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.

  PMID: 25995680 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Fluorouracil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Baocai Xing, Doctor

  1st Department of HBP Surgery.Beijing Cancer Hospital

  STUDY DIRECTOR

• Xu Zhu, Doctor

  Interventional therapy department of Beijing Cancer Hospital

  STUDY DIRECTOR

Central Study Contacts

Guang Cao, Doctor

CONTACT

86-138-1165-2497; caoguang1207@bjmu.edu.cn

Wei Liu, Doctor

CONTACT

86-138-1083-9736; huoxinglaotai@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chief of Department of Hepatobiliary Pancreatic Surgery Ward

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: May 10, 2016
• Study Start: February 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 10, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)