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TACE Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02630108
Collaborator
Xijing Hospital (Other), Changhai Hospital (Other), Eastern Hepatobiliary Surgery Hospital (Other), Shanghai Cancer Hospital, China (Other), Shengjing Hospital (Other), The Third Affiliated Hospital of Harbin Medical University (Other), Jilin Provincial Tumor Hospital (Other), Zhejiang Cancer Hospital (Other), Jiangsu Cancer Institute & Hospital (Other), Guangdong Provincial People's Hospital (Other), Sichuan Cancer Hospital and Research Institute (Other), Henan Cancer Hospital (Other), Anhui Provincial Hospital (Other), The First Affiliated Hospital of Anhui Medical University (Other), Qilu Hospital of Shandong University (Other), Shandong Tumor Hospital (Other), First Affiliated Hospital of Xinjiang Medical University (Other), Chinese PLA General Hospital (Other), Nanfang Hospital of Southern Medical University (Other), Wuhan Union Hospital, China (Other), LanZhou University (Other), Sun Yat-sen University (Other), Hunan Provincial People's Hospital (Other), The Affiliated Zhongshan Hospital of Dalian University (Other)
280
Enrollment
1
Location
2
Arms
28
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

It is a prospective and multi-center clinical research in China to compare the efficacy, safety and related impact factors between TACE alone and TACE combined with synchronous multi-point MWA/RFA for large and huge liver cancer.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Thermal Ablation
  • Drug: EADM
  • Drug: Ultra-fluid lipiodol
  • Other: Gelatin sponge articles
 Phase 3

Detailed Description

It is an open random prospective phase III clinical trial conducted by Principal Investigator Professor Jian-Hua Wang. Investigators in twenty-five hospitals in China participate in. Patients with unresectable large HCC (>5cm in diameter) and huge HCC (>=10cm in diameter) are enrolled. The investigators propose to recruitment 280 patients who are randomly assigned into the combined group (treated with TACE and synchronous ablation) and the control group (treated with TACE alone) according to the proportion of 1:1, which means 140 patients in each group. The criteria of inclusion and exclusion, and the methods of lab tests, imaging modality and treatment procedures are the same.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of Transarterial Chemoembolization (TACE) Combined With Synchronous Radiofrequency /Microwave Ablation to Treat Large and Huge Hepatocellular Carcinoma
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thermal Ablation & TACE

Transarterial chemoembolization (TACE) is performed immediately following thermal ablation. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

Procedure: Thermal Ablation
Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.
Other Names:
  • Radiofrequency ablation
  • Microwave ablation

    • Drug: EADM
    EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
    Other Names:
  • Epirubicin

    • Drug: Ultra-fluid lipiodol
    Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
    Other Names:
  • lipiodol

    • Other: Gelatin sponge articles
    Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
    Active Comparator: TACE alone

    Only TACE is performed. EADM, ultra-fluid lipiodol and gelatin sponge articles are used in TACE.

    Drug: EADM
    EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
    Other Names:
  • Epirubicin

    • Drug: Ultra-fluid lipiodol
    Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
    Other Names:
  • lipiodol

    • Other: Gelatin sponge articles
    Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [From the date of randomization until the date of death from any cause, assessed up to 26 months]

    Secondary Outcome Measures

    1. Time-to-Disease Progression [From the date of first procedure of TACE or TACE combined with synchronous ablation until the time when the disease progresses from an intermediate to an advanced stage as defined by specific events, assessed up to 26 months]

      TTDP follow-up is done at three months interval after lesions defined as stable with treatment of TACE or ablation combined with synchronous TACE six months after enrollment until lesions are defined as disease progression.

    2. Objective response rate (ORR) [Six months after the date of first procedure of TACE or TACE combined with synchronous ablation.]

      The ratio of CR plus PR. The efficacy is defined as complete regression (CR), partial regression (PR), stable disease (SD) and progressive disease (PD) according to modified Response Evaluation Criteria in Solid Tumors (mRESIST)

    3. Progression free survival(PFS) [From the date of first procedure of TACE or TACE combined with synchronous ablationto until the time when lesions are defined as disease progression or death by any cause,assessed up to 26 months.]

    4. Numbers of TACE and TACE combined with ablation cycles [From the date of randomization until the date of death, assessed up to 26 months.]

      The times of the subjects undergoing TACE or TACE combined with ablation

    5. Number of participants with adverse events and severe adverse events in TACE alone and TACE combined with ablation groups [From the date of randomization until the date of follow-up visit (30 days after the procedure of TACE or TACE combined with thermal ablation)]

      Serious or mild adverse events after treatment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Patients with primary liver cancer aged from 18-80 years, and life expectancy longer than three months;

    2. Patients with large HCC (>5cm in diameter) and huge HCC (≥10cm in diameter), including HCC and mixed type of liver cancer (HCC-ICC);

    3. Patients with no thrombus in main portal vein (PV)

    4. Patients' liver function classified as Child-Pugh A or B, ECOG PS ≤ 2;

    5. Patients without bleeding tendency or coagulation disorder, or with reversible coagulopathy after therapy;

    6. White blood cell count ≥ 3.0×10^9/L;

    7. Hemoglobin ≥ 8.5g/dl;

    8. Platelet ≥ 50×10^9/L;

    9. INR ≤ 2.3 or PT not exceeding the upper limit of reference 3 seconds;

    10. Blood creatinine less than 1.5 times of upper limit of reference;

    11. Patients and/or their relatives willing to join in the clinical trial and signing the informed consent.

    Exclusion Criteria:

    1. Patients with diffuse type of liver cancer;

    2. Cholangiocellular carcinoma

    3. Patients with main PV thrombus;

    4. Patients with hepatic vein thrombus;

    5. Patients with lymph node or distant metastasis outside of liver;

    6. Patients' liver function classified as Child-Pugh C and no improvement after treatment of liver protection;

    7. Patients with irreversible coagulation disorder and abnormality in blood routine test, or having obvious bleeding tendency;

    8. Patients with intractable massive ascites;

    9. Patients' ECOG PS >2;

    10. Patients complicated with active infection, especially cholangitis;

    11. Patients with severe disorders of heart, lungs, kidneys, or brain;

    12. Patients and/or their relatives refuse to anticipate this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Interventional Radiology, Zhongshan Hospital, Fudan University Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Shanghai Zhongshan Hospital
    • Xijing Hospital
    • Changhai Hospital
    • Eastern Hepatobiliary Surgery Hospital
    • Shanghai Cancer Hospital, China
    • Shengjing Hospital
    • The Third Affiliated Hospital of Harbin Medical University
    • Jilin Provincial Tumor Hospital
    • Zhejiang Cancer Hospital
    • Jiangsu Cancer Institute & Hospital
    • Guangdong Provincial People's Hospital
    • Sichuan Cancer Hospital and Research Institute
    • Henan Cancer Hospital
    • Anhui Provincial Hospital
    • The First Affiliated Hospital of Anhui Medical University
    • Qilu Hospital of Shandong University
    • Shandong Tumor Hospital
    • First Affiliated Hospital of Xinjiang Medical University
    • Chinese PLA General Hospital
    • Nanfang Hospital of Southern Medical University
    • Wuhan Union Hospital, China
    • LanZhou University
    • Sun Yat-sen University
    • Hunan Provincial People's Hospital
    • The Affiliated Zhongshan Hospital of Dalian University

    Investigators

    • Principal Investigator: Jianhua Wang, MD, Shanghai Zhongshan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Shanghai Zhongshan Hospital
    ClinicalTrials.gov Identifier:
    NCT02630108
    Other Study ID Numbers:
    • B2015-146R
    First Posted:
    Dec 15, 2015
    Last Update Posted:
    Oct 18, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Shanghai Zhongshan Hospital
    HCC
    TACE
    Thermal Ablation
    Safety/Efficacy
    Additional relevant MeSH terms:
    Carcinoma
    Carcinoma, Hepatocellular
    Epirubicin
    Ethiodized Oil

    Study Results

    No Results Posted as of Oct 18, 2016