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出境医 / 临床实验 / A Study on the Angioarchitecture of Hepatocellular Carcinoma

A Study on the Angioarchitecture of Hepatocellular Carcinoma

Study Description
Brief Summary:
Hepatocellular carcinoma (HCC) is one of the commonest solid malignancies in Hong Kong as well as globally. Transarterial therapy has been playing an important role in the treatment algorithm for patients with HCC. The primary purpose of transarterial therapy is eradication of the viability of the targeted tumors. The treatment outcomes have been variable among the various treatments, in general, there is still much room for improvement, especially for large size tumors. From the studies on Transarterial chemoembolization (TACE), it is known that the treatment outcome is affected by the nature and the formulation of therapeutic agents that are delivered, which is related to the angioarchitecture of the tumor. Knowledge on the angioarchitecture of HCC is essential for the understanding of the requirements for effective transarterial treatment of HCC. This prospective study is aimed to study the angioarchitecture of HCC.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Other: embolization Not Applicable

Detailed Description:

Embolization is performed within 2 weeks before the scheduled date of partial hepatectomy. The purpose of the timing is two folded, it allows observation of the embolization effect to be differentiated among the various embolic agents, it also allows time for the patient and the liver to recover from the embolization.

The patient then receives partial hepatectomy within 2 weeks unless the result of liver function tests shows contraindication to surgery, in which case the liver function test is further evaluated on a weekly basis until the findings are acceptable, and surgery is scheduled accordingly.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Tumors are categorized into 3 groups based on the longest diameter of the largest tumor:

Group 1: ≤3cm Group 2: >3cm to 7cm Group 3: >7cm
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Study on the Angioarchitecture of Hepatocellular Carcinoma
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021
Arms and Interventions
Arm Intervention/treatment
Tumor <=3cm
Embolization with particulate or liquid embolic agent
 Other: embolization
Patient with a diagnosis of HCC and a treatment plan to receive partial hepatectomy will receive transarterial embolization under local anesthesia 2 weeks before the surgery. Angiographic examinations of the tumor before and after embolization of the tumor will be performed. Histological examination of the tumor in the surgical specimens will be performed.
Tumor >3cm to 7cm
Embolization with particulate or liquid embolic agent
 Other: embolization
Patient with a diagnosis of HCC and a treatment plan to receive partial hepatectomy will receive transarterial embolization under local anesthesia 2 weeks before the surgery. Angiographic examinations of the tumor before and after embolization of the tumor will be performed. Histological examination of the tumor in the surgical specimens will be performed.
Tumor > 7cm
Embolization with particulate or liquid embolic agent
 Other: embolization
Patient with a diagnosis of HCC and a treatment plan to receive partial hepatectomy will receive transarterial embolization under local anesthesia 2 weeks before the surgery. Angiographic examinations of the tumor before and after embolization of the tumor will be performed. Histological examination of the tumor in the surgical specimens will be performed.
Outcome Measures
Primary Outcome Measures :
  1. arterial flow through the tumor [ Time Frame: within one hour ]
    Digital subtraction angiography (DSA) is performed before and after embolization, through catheterization of the arterial branches supplying the tumor, images from arterial phase to delayed phase are captured. Contrast distribution at the arterial tumor branches, arterioles, tumor sinusoids, peri-tumoral liver, and peri-tumoral portal venules are observed.


Secondary Outcome Measures :
  1. The degree of tumor necrosis [ Time Frame: within 2 weeks after embolization ]
    The percentage of viable residual HCC is assessed quantitatively in increments of 5 %, with the measurement of the largest axial diameter of viable HCC compared to that of the whole tumor using a microscopic ruler.


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age above 18 years
  2. HCC suitable for partial hepatectomy
  3. Child-Pugh A or B cirrhosis
  4. Eastern Cooperative Oncology Group performance score 0 or 1
  5. Barcelona clinic liver cancer (BCLC) staging A or B
  6. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
  7. Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)

Exclusion Criteria:

  1. Previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
  2. Evidence of tumor invasion of portal vein or hepatic vein
  3. History of acute tumor rupture presenting with hemo-peritoneum
  4. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
  5. Serum creatinine level > 150umol/L
Contacts and Locations

Contacts
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Contact: Carmen Wong (852) 3505 3210 carmenwongsp@cuhk.edu.hk
Contact: Pui Man Chong (852) 3505 4094 siuman@cuhk.edu.hk

Locations
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Hong Kong
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong Recruiting
Hong Kong, Hong Kong
Contact: Carmen Wong    (852)3505 3210    carmenwongsp@cuhk.edu.hk   
Contact: Pui Man Chong    (852)3505 4094    siuman@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Simon Yu DIIR, CUHK, Hong Kong
Tracking Information
First Submitted Date  ICMJE October 10, 2018
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date February 24, 2021
Actual Study Start Date  ICMJE August 13, 2018
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019) 		arterial flow through the tumor [ Time Frame: within one hour ]
Digital subtraction angiography (DSA) is performed before and after embolization, through catheterization of the arterial branches supplying the tumor, images from arterial phase to delayed phase are captured. Contrast distribution at the arterial tumor branches, arterioles, tumor sinusoids, peri-tumoral liver, and peri-tumoral portal venules are observed.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019) 		The degree of tumor necrosis [ Time Frame: within 2 weeks after embolization ]
The percentage of viable residual HCC is assessed quantitatively in increments of 5 %, with the measurement of the largest axial diameter of viable HCC compared to that of the whole tumor using a microscopic ruler.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Angioarchitecture of Hepatocellular Carcinoma
Official Title  ICMJE A Study on the Angioarchitecture of Hepatocellular Carcinoma
Brief Summary Hepatocellular carcinoma (HCC) is one of the commonest solid malignancies in Hong Kong as well as globally. Transarterial therapy has been playing an important role in the treatment algorithm for patients with HCC. The primary purpose of transarterial therapy is eradication of the viability of the targeted tumors. The treatment outcomes have been variable among the various treatments, in general, there is still much room for improvement, especially for large size tumors. From the studies on Transarterial chemoembolization (TACE), it is known that the treatment outcome is affected by the nature and the formulation of therapeutic agents that are delivered, which is related to the angioarchitecture of the tumor. Knowledge on the angioarchitecture of HCC is essential for the understanding of the requirements for effective transarterial treatment of HCC. This prospective study is aimed to study the angioarchitecture of HCC.
Detailed Description

Embolization is performed within 2 weeks before the scheduled date of partial hepatectomy. The purpose of the timing is two folded, it allows observation of the embolization effect to be differentiated among the various embolic agents, it also allows time for the patient and the liver to recover from the embolization.

The patient then receives partial hepatectomy within 2 weeks unless the result of liver function tests shows contraindication to surgery, in which case the liver function test is further evaluated on a weekly basis until the findings are acceptable, and surgery is scheduled accordingly.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Tumors are categorized into 3 groups based on the longest diameter of the largest tumor:

Group 1: ≤3cm Group 2: >3cm to 7cm Group 3: >7cm

Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Carcinoma, Hepatocellular
Intervention  ICMJE Other: embolization
Patient with a diagnosis of HCC and a treatment plan to receive partial hepatectomy will receive transarterial embolization under local anesthesia 2 weeks before the surgery. Angiographic examinations of the tumor before and after embolization of the tumor will be performed. Histological examination of the tumor in the surgical specimens will be performed.
Study Arms  ICMJE
  • Tumor <=3cm
    Embolization with particulate or liquid embolic agent
    Intervention: Other: embolization
  • Tumor >3cm to 7cm
    Embolization with particulate or liquid embolic agent
    Intervention: Other: embolization
  • Tumor > 7cm
    Embolization with particulate or liquid embolic agent
    Intervention: Other: embolization
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2019) 		84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age above 18 years
  2. HCC suitable for partial hepatectomy
  3. Child-Pugh A or B cirrhosis
  4. Eastern Cooperative Oncology Group performance score 0 or 1
  5. Barcelona clinic liver cancer (BCLC) staging A or B
  6. HCC diagnosed by typical enhancement patterns on cross sectional imaging or histology
  7. Massive expansive tumor morphology with measurable lesion on CT (characterized by well-defined spherical or globular configuration, with or without tumor capsule or satellite lesions)

Exclusion Criteria:

  1. Previous treatment with liver resection, ablation, chemotherapy, radiotherapy or transarterial embolization (with or without chemotherapy),
  2. Evidence of tumor invasion of portal vein or hepatic vein
  3. History of acute tumor rupture presenting with hemo-peritoneum
  4. Infiltrative tumor morphology (characterized by ill- defined tumor margin and amorphous configuration) or diffuse tumor morphology (characterized by large number of small nodules)
  5. Serum creatinine level > 150umol/L
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Carmen Wong (852) 3505 3210 carmenwongsp@cuhk.edu.hk
Contact: Pui Man Chong (852) 3505 4094 siuman@cuhk.edu.hk
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03808766
Other Study ID Numbers  ICMJE VIR-18-09
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Simon Yu, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Simon Yu DIIR, CUHK, Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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