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

NCT03314532 | Unknown DMC

• 1 other identifier: SAHZhejiangU-2017-071
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Surgical Resection; HCC

Keywords

Surgical Resection; TILA-TACE; Hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• disease-progression-free period

  This will be the time period from the beginning of treatment to the time that disease progression has been observed.

  This will be the time period from the beginning of treatment to the time that disease progression has been observed (up to 120 months).

Secondary Outcomes (1)

• overall survival period

  from the beginning of the treatment, until the death of the patient or the end of the study period (up to 100 months).

Study Arms (2)

Surgery group

NO INTERVENTION

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.

TILA-TACE group

EXPERIMENTAL

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.

Procedure: TILA-TACE

Interventions

TILA-TACE 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.

TILA-TACE group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-75 with no gender, ethnicity, religion, or geographical restrictions.
• Diagnosed HCC patient.
• 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.
• Imaging examination with no cancer embolus above the secondary branch of the portal vein.
• New lesions found five years after liver cancer treatment.
• Child-Pugh A or B grade liver function.
• No concurrent malignancies in other systems.
• Informed subjects who fully understand and willingly cooperate with the test program with signed relevant documents.

You may not qualify if:

• Suffer from other malignancies.
• Have received any other liver cancer treatments.
• Pathological diagnosis as non-HCC.
• Experience large blood vessel invasion, distant metastases, or unresectable liver cancer.
• One or more organ failures.
• Child-Pugh C grade liver function.
• Incomplete surgical resection or TILA-TACE.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hanzhou, Zhejiang, 310009, China

Location

Related Publications (4)

• 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.

  PMID: 26607931 RESULT

• 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.

  PMID: 22424438 RESULT

• 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.

  PMID: 27481188 RESULT

• 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.

  PMID: 19212170 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jiang-tao Li, MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Yun Jin, MD

CONTACT

86-1358140070; william99@126.com

Xiao-xiao Zhang, BS

CONTACT

86-15068764532; zxiaoxiao204@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Cases will be randomized by computer into the groups
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled experimental design method will be adopted.

Study Record Dates

• First Submitted: October 8, 2017
• First Posted: October 19, 2017
• Study Start: November 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2022
• Last Updated: October 19, 2017

Record last verified: 2017-09

Locations

CN (1)