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Hepatocellular Carcinoma(HCC)NCT01642446

Optimal Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension

A study testing Precise hepatectomy and Combined intervention (chemoembolization/ablation) in people with Hepatocellular Carcinoma(HCC) and Cirrhotic Portal Hypertension, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

There is no consensus about the optimal treatment of hepatocellular carcinoma (HCC) with cirrhotic portal hypertension, While this group of patients are classified as hepatectomy contraindication according to guidelines from National Comprehensive Cancer Network (NCCN) and American Association for the Study of Liver… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Precise hepatectomy and Combined intervention (chemoembolization/ablation)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteChina
Study dates
Jan 2013to 30 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of hepatocellular carcinoma patients, in accordance with HCC Professional Committee of the Chinese Anti-Cancer Association 2001 "Clinical Diagnosis of Primary Liver Cancer and Staging Criteria"
  • solitary tumor ≤5cm, or three or fewer lesions none ≤3cm，As Milan criteria
  • History of hepatitis B or HBsAg positive
  • Cirrhosis and portal hypertension
  • No treatment on liver cancer before
  • KPS score ≥ 70
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  • The age of 18 to 65 years
  • Child-Pugh A or B (Class B, scoring no more than 7 points)
  • Baseline laboratory test comply with the following criteria:
  • White blood cell ≥ 1.0×109/L
  • Platelet ≥ 25×109/L
  • Hemoglobin ≥ 80g/L
  • Serum ALT,AST ≤ 3×upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 × ULN
  • INR<1.5, or prothrombin time <ULN +4 sec
  • Albumin ≥30g/L
  • Total bilirubin ≤34mmol/L
  • Informed consent with signature and time
  • Good patient compliance
  • The surgical group patients received radical hepatectomy. Radical surgery is defined as: complete resection of visible tumor, R0 resection margins, and also including:
  • The number of tumors is less than 3
  • No tumor thrombus found in major branch of the portal veins, hepatics, inferior vena cava or bile duct
  • No hepatic hilar lymph node metastasis
  • No extrahepatic metastasis

Who cannot join

  • extrahepatic metastasis; With metastasis in major branch of portal vein, hepatic vein
  • History of hepatitis C or HCV-Ab positive
  • Pugh Child-Pugh C, or with massive ascites or had a history of hepatic encephalopathy, or Upper digestive tract bleeding
  • Poor physical condition or cachexia
  • During the past 12 months just before the study, there had been any of the following: myocardial infarction, severe/unstable angina, coronary artery bypass graft surgery, congestive heart failure, cerebrovascular accident (including transient ischemic attack), pulmonary embolism; arrhythmia according to the NCI-CTCAE ≥ grade 2, QTc interval extension (male> 450 ms, female> 470 ms);
  • Renal insufficiency, need peritoneal dialysis or hemodialysis
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  • Serious dysfunction of other organs
  • History of second primary malignant tumors
  • Known or new evidence of brain or leptomeningeal disease
  • Hemophilia or bleeding tendency, and are taking therapeutic doses of coumarin derivative anticoagulant therapy drugs
  • Pregnant or lactation, all female patients with childbearing potential must have a pregnancy test (serum or urine) within 7 days after enrollment,and the result is negative
  • History of organ transplantation
  • Known HIV infection
  • With any other serious acute and chronic physical or mental disease or abnormal laboratory tests, which are likely to increase risks or interfere with the interpretation of the results, or researchers believe that patients are not suitable for enrollment

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Randomized Control Clinical Trial Between Precise Hepatectomy and Combined Interventional Treatment on Hepatocellular Carcinoma (HCC) With Cirrhotic Portal Hypertension

There is no consensus about the optimal treatment of hepatocellular carcinoma (HCC) with cirrhotic portal hypertension, While this group of patients are classified as hepatectomy contraindication according to guidelines from National Comprehensive Cancer Network (NCCN) and American Association for the Study of Liver Diseases (AASLD). With improvement of surgical technique, preoperative evaluation, and perioperative management,especially the Precise Hepatectomy Technique, more and more studies confirmed the safety of surgical intervention to hepatocellular carcinoma (HCC) patients with cirrhotic portal hypertension.However, most of the previous studies were either retrospective or with small samples.

The investigators project is a prospective randomized controlled trial, planning to compare the safety, efficacy and quality of life between precise hepatectomy and combined interventional treatment on hepatocellular carcinoma (HCC) with cirrhotic portal hypertension, to make a further understanding of optimal strategy.

Being tested
Precise hepatectomy, Combined intervention (chemoembolization/ablation)
Keywords
precise hepatectomy, hepatocellular carcinoma, cirrhotic, portal hypertension, safety, combined interventional treatment
Medical subject headings
Carcinoma, Hepatocellular, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Precise hepatectomyProcedure or surgery

    Precise hepatectomy

  • Combined intervention (chemoembolization/ablation)Other

    transcatheter hepatic arterial chemoembolization and/or ablation

Study groups in NCT01642446
Study groupRoleWhat they receive
surgeryExperimentalPrecise hepatectomy
Receives: Procedure: Precise hepatectomy
combined interventionActive comparatortranscatheter hepatic arterial chemoembolization and/or ablation
Receives: Other: Combined intervention (chemoembolization/ablation)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Overall survival is based on death from any cause, not just the condition being treated, thus it picks up death from side effects of the treatment, and effects on survival after relapse

    Measured: 5 years

Secondary outcomes (4)

  1. Treatment complication

    defined as complications within the 90 days after treatment

    Measured: 90 days

  2. Time to progress(TTP)

    TTP: The Hazard Ratio will be analyzed respectively with 95% confidence interval. Meanwhile, Kaplan-Meier estimation and survival curves will be performed.

    Measured: 3 years

  3. Disease control rate(DCR)

    Disease control rate: Calculate the disease control rate of the two treatment groups (disease control rate) and its 95% confidence interval, and make a descriptive analysis.

    Measured: 3 years

  4. Quality of life(Qol)

    Quality of life: Follow the QOL-LC V2.0

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2012 (estimated)
  2. Study startJan 2013
  3. Primary completion30 Dec 2018
  4. Study completion30 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
transartery embolization chemotherapy, infusion of Chemoembolization was performed using 30 mg/m2 of epirubicin, 200 mg/m2 of carboplatin, and 4mg/m2 of mitomycin C (MMC), mixed with 2-5 mL lipiodol. Then up to 20 mL of additional pure lipiodol was injected into the tumor-feeding artery until stasis of blood flow in the target artery was observed
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01642446
Sponsor's protocol ID
20125010Y
Status last verified
Sep 2021
First submitted
12 Jul 2012
Last updated
27 Sep 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Yuan Y, Peng H, He W, Zheng Y, Qiu J, Chen B, Zou R, Wang C, Lau WY, Li B, Yuan Y. Partial hepatectomy versus interventional treatment in patients with hepatitis B virus-related hepatocellular carcinoma and clinically significant portal hypertension: a randomized comparative clinical trial. Cancer Commun (Lond). 2024 Nov;44(11):1337-1349. doi: 10.1002/cac2.12614. Epub 2024 Sep 25.

    PubMed 39322951

Questions about this trial

What is this clinical trial studying?

A study testing Precise hepatectomy and Combined intervention (chemoembolization/ablation) in people with Hepatocellular Carcinoma(HCC) and Cirrhotic Portal Hypertension, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01642446, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.

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