MedDataX Logo

The Efficacy of Hepatectomy or TILA-TACE in Patients With Resectable Hepatocellular Carcinoma

NCT ID: NCT03314532

Last Updated: 2017-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Hepatocellular carcinoma (HCC) is one of the most common cancers in the world with major occurrences in eastern Asian countries such as China. HCC is the third leading cause of cancer-related deaths in the world. There are multiple treatment options for liver cancer including surgery, transcatheter arterial chemoembolization (TACE), liver transplantation, absolute ethanol injection, radiation therapy, and biological therapy. Surgery is the primary radical treatment measure for HCC, but its indication is narrow and is only suitable for certain group of patients. Another common treatment for liver cancer, TACE, can not only block tumor blood supply, control tumor growth, or even cause necrosis and result in tumor shrinkage, it can also deliver target chemotherapy drugs to the tumor tissue. However, there are still some controversies on the efficacy of TACE treatment. Therefore in this study, we will conduct a randomized comparison study of the efficacy of surgical resection and TILA-TACE treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The Barcelona Clinic Liver Cancer staging system (BCLC) is one of the more recognized staging criteria and has been recommended by the European Association for the Study of Liver and the American Association for the Study of Liver Diseases. BCLC staging is based on patients' general condition, tumor condition, and liver function to identify the best treatment option and predict prognosis using evidence-based medicine. Surgical excision is recommended for BCLC stage 0, liver transplantation or radiofrequency ablation is recommended for BCLC stage A, and TACE treatment is recommended for BCLC stage B.

However, there are still some controversies on the efficacy of TACE treatment. In recent years, development of technologies has led to improved methods including targeting-intratumoral-lactic-acidosis TACE (TILA-TACE). Early clinical practice has confirmed that compared with TACE, TILA-TACE has a relatively high response rate and efficiency. In clinical practice, the current standard treatments for patients with surgically resectable HCC are controversial and there is no recommendation in the guidelines.

This study is designed to evaluate and compare the therapeutic efficacies of surgical resection and TILA-TACE treatment in patients with resectable HCC.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Resection HCC

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Surgical Resection TILA-TACE Hepatocellular carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized controlled experimental design method will be adopted.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Cases will be randomized by computer into the groups

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surgery group

We will completely resection of the visible tumor and made the resection margin negative. We will use regular/irregular resection of the liver tumor tissue, hemihepatectomy or extended hepatectomy.

Group Type NO_INTERVENTION

No interventions assigned to this group

TILA-TACE group

After femoral artery catheterization, 5-Fr angiography catheters will be used for complete radiography of the celiac artery, the hepatic artery proper, left and right hepatic arteries and their branches, and 2.8-Fr micro-catheters will be used for complete radiography of the tumor's nutrient arteries. Lipiodol-epirubicin emulsions and 5% sodium bicarbonate injection solutions will be used for perfusion of chemotherapy drugs. Different sizes of embolic microspheres will be used alternatively for chemoembolization.

Group Type EXPERIMENTAL

TILA-TACE

Intervention Type PROCEDURE

After femoral artery catheterization, 5-Fr angiography catheters will be used for complete radiography of the celiac artery, the hepatic artery proper, left and right hepatic arteries and their branches, and 2.8-Fr micro-catheters will be used for complete radiography of the tumor's nutrient arteries. Lipiodol-epirubicin emulsions and 5% sodium bicarbonate injection solutions will be used for perfusion of chemotherapy drugs. Different sizes of embolic microspheres will be used alternatively for chemoembolization.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TILA-TACE

After femoral artery catheterization, 5-Fr angiography catheters will be used for complete radiography of the celiac artery, the hepatic artery proper, left and right hepatic arteries and their branches, and 2.8-Fr micro-catheters will be used for complete radiography of the tumor's nutrient arteries. Lipiodol-epirubicin emulsions and 5% sodium bicarbonate injection solutions will be used for perfusion of chemotherapy drugs. Different sizes of embolic microspheres will be used alternatively for chemoembolization.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Ages 18-75 with no gender, ethnicity, religion, or geographical restrictions.
2. Diagnosed HCC patient.
3. The following criteria will be used for the evaluation of tumor resectability and adequate remaining liver volume: ≥ 30% remaining liver volume/total liver volume for non-hepatitis patients; ≥ 40% remaining liver volume/total liver volume for hepatitis patients.
4. Imaging examination with no cancer embolus above the secondary branch of the portal vein.
5. New lesions found five years after liver cancer treatment.
6. Child-Pugh A or B grade liver function.
7. No concurrent malignancies in other systems.
8. Informed subjects who fully understand and willingly cooperate with the test program with signed relevant documents.

Exclusion Criteria

1. Suffer from other malignancies.
2. Have received any other liver cancer treatments.
3. Pathological diagnosis as non-HCC.
4. Experience large blood vessel invasion, distant metastases, or unresectable liver cancer.
5. One or more organ failures.
6. Child-Pugh C grade liver function.
7. Incomplete surgical resection or TILA-TACE.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jiang-tao Li, MD

Role: STUDY_DIRECTOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Second Affiliated Hospital Zhejiang University School of Medicine

Hanzhou, Zhejiang, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yun Jin, MD

Role: CONTACT

Phone: 86-1358140070

Email: [email protected]

Xiao-xiao Zhang, BS

Role: CONTACT

Phone: 86-15068764532

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jiang-tao Li, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

Sastre J, Diaz-Beveridge R, Garcia-Foncillas J, Guardeno R, Lopez C, Pazo R, Rodriguez-Salas N, Salgado M, Salud A, Feliu J. Clinical guideline SEOM: hepatocellular carcinoma. Clin Transl Oncol. 2015 Dec;17(12):988-95. doi: 10.1007/s12094-015-1451-3. Epub 2015 Nov 25.

Reference Type RESULT
PMID: 26607931 (View on PubMed)

European Association For The Study Of The Liver; European Organisation For Research And Treatment Of Cancer. EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. J Hepatol. 2012 Apr;56(4):908-43. doi: 10.1016/j.jhep.2011.12.001. No abstract available.

Reference Type RESULT
PMID: 22424438 (View on PubMed)

Chao M, Wu H, Jin K, Li B, Wu J, Zhang G, Yang G, Hu X. A nonrandomized cohort and a randomized study of local control of large hepatocarcinoma by targeting intratumoral lactic acidosis. Elife. 2016 Aug 2;5:e15691. doi: 10.7554/eLife.15691.

Reference Type RESULT
PMID: 27481188 (View on PubMed)

Zhou WP, Lai EC, Li AJ, Fu SY, Zhou JP, Pan ZY, Lau WY, Wu MC. A prospective, randomized, controlled trial of preoperative transarterial chemoembolization for resectable large hepatocellular carcinoma. Ann Surg. 2009 Feb;249(2):195-202. doi: 10.1097/SLA.0b013e3181961c16.

Reference Type RESULT
PMID: 19212170 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SAHZhejiangU-2017-071

Identifier Type: -

Identifier Source: org_study_id