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Adjuvant Chemotherapy With FOLFOX in HCC Patients After Resection

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ClinicalTrials.gov Identifier: NCT02738697
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Rong-ping Guo, Sun Yat-sen University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Adjuvant chemotherapy Procedure: Follow-up Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Clinical Randomized Trial of Adjuvant Chemotherapy With FOLFOX in HCC Patients at High Risk After Resection
Study Start Date : January 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Adjuvant chemotherapy
8~12 cycles of adjuvant chemotherapy with FOLFOX were performed 4-6 weeks after radical surgery
Drug: Adjuvant chemotherapy
8~12 cycles of adjuvant chemotherapy with FOLFOX were performed 4-6 weeks after radical surgery
Other Name: adjuvant chemotherapy with FOLFOX

Follow-up
Routine follow-up were performed instead of adjuvant chemotherapy
Procedure: Follow-up
Patients received just follow-up instead of adjuvant chemotherapy




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]
    The overall survival is defined as the percentage of patients who are alive at 5 years after their enrollments of this study.


Secondary Outcome Measures :
  1. Disease-free survival [ Time Frame: 5 years ]
    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.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 5 years ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18~75 years;
  2. Eastern Cooperative Oncology Group performance status (ECOG PS) score <=2;
  3. Histologically confirmed hepatocellular carcinoma with microvessels invasion;
  4. No previous treatment for HCC;
  5. More than 5 cm solitary tumor before surgery confirmed by more than 2 radiological examinations;
  6. R0 resection achieved;
  7. No recurrence evidence in radiological follow-up 3~5 weeks after surgery;
  8. 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;
  9. Give signed informed consent before enrollment.

Exclusion Criteria:

  1. 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);
  2. Histologically confirmed of positive resection margin (R1 resection);
  3. Previous or current malignant tumor beyond HCC;
  4. Allergy to any agent of the FOLFOX regimen;
  5. History of organ transplantation;
  6. Previously receiving other treatments for HCC;
  7. Pregnant or breastfeeding women, and women of childbearing potential without adequate contraception;
  8. Neurological or mental abnormalities that may affect cognitive assessment and inform consent;
  9. Concomitant anti-tumor therapy or participating in other interventional clinical trials;
  10. Other psychological, family or social reason, which would affect compliance with the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738697


Contacts
Contact: Rong-Ping Guo, M.D. 00862087342266 guorp@sysucc.org.cn
Contact: Wei Wei, Ph.D. M.D. 00862087343790 weiwei@sysucc.org.cn

Locations
China, Guangdong
SUN YAT-SEN University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Rong-Ping Guo, M.D.    00862087342266    guorp@sysucc.org.cn   
Contact: Wei Wei, Ph.D. M.D.    00862087343790    weiwei@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Rong-Ping Guo, M.D. Sun Yat-sen University

Publications of Results:

Responsible Party: Rong-ping Guo, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02738697     History of Changes
Other Study ID Numbers: SYSUCC-HCC-ADCHEMO
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rong-ping Guo, Sun Yat-sen University:
Carcinoma,Hepatocellular
Adjuvant chemotherapy
Microvessels invasion
Survival
Recurrence

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases